Trial Outcomes & Findings for Study to Determine the Efficacy and Safety of a Novel Nicotine Replacement Therapy (NCT NCT02355665)
NCT ID: NCT02355665
Last Updated: 2019-01-08
Results Overview
Percentage of participants with carbon monoxide (CO)-verified self-report of continuous abstinence from smoking
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
1198 participants
Primary outcome timeframe
Week 2 to Week 6
Results posted on
2019-01-08
Participant Flow
Participant milestones
| Measure |
Placebo
Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions
|
Nicotine
Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions
|
|---|---|---|
|
Overall Study
STARTED
|
601
|
597
|
|
Overall Study
COMPLETED
|
352
|
365
|
|
Overall Study
NOT COMPLETED
|
249
|
232
|
Reasons for withdrawal
| Measure |
Placebo
Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions
|
Nicotine
Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions
|
|---|---|---|
|
Overall Study
Adverse Event
|
16
|
24
|
|
Overall Study
Protocol Violation
|
2
|
0
|
|
Overall Study
Withdrawal by Subject
|
90
|
100
|
|
Overall Study
Lost to Follow-up
|
131
|
103
|
|
Overall Study
Death
|
4
|
2
|
|
Overall Study
Compliance, PI decision, move, eligible
|
6
|
3
|
Baseline Characteristics
Study to Determine the Efficacy and Safety of a Novel Nicotine Replacement Therapy
Baseline characteristics by cohort
| Measure |
Placebo
n=601 Participants
Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions
|
Nicotine
n=597 Participants
Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions
|
Total
n=1198 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
51.2 years
STANDARD_DEVIATION 11.72 • n=5 Participants
|
51.5 years
STANDARD_DEVIATION 11.7 • n=7 Participants
|
51.3 years
STANDARD_DEVIATION 11.71 • n=5 Participants
|
|
Sex: Female, Male
Female
|
319 Participants
n=5 Participants
|
332 Participants
n=7 Participants
|
651 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
282 Participants
n=5 Participants
|
265 Participants
n=7 Participants
|
547 Participants
n=5 Participants
|
|
Region of Enrollment
United States · USA
|
601 Participants
n=5 Participants
|
597 Participants
n=7 Participants
|
1198 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Week 2 to Week 6Population: Analysis was based on the Full Analysis Set which included all randomized participants.
Percentage of participants with carbon monoxide (CO)-verified self-report of continuous abstinence from smoking
Outcome measures
| Measure |
Placebo
n=601 Participants
Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions
|
Nicotine
n=597 Participants
Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions
|
|---|---|---|
|
Percentage of Participants With Continuous Smoking Abstinence From Week 2 to Week 6
|
2.5 Percentage of Participants
|
5.0 Percentage of Participants
|
SECONDARY outcome
Timeframe: Week 2 to Week 12Population: Analysis was based on the Full Analysis Set which included all randomized participants.
Percentage of participants with carbon monoxide (CO)-verified self-report of continuous abstinence from smoking
Outcome measures
| Measure |
Placebo
n=601 Participants
Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions
|
Nicotine
n=597 Participants
Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions
|
|---|---|---|
|
Percentage of Participants With Continuous Smoking Abstinence From Week 2 to Week 12
|
1.3 Percentage of Participants
|
4.0 Percentage of Participants
|
SECONDARY outcome
Timeframe: Week 2 to Week 26Population: Analysis was based on the Full Analysis Set which included all randomized participants.
Percentage of participants with carbon monoxide (CO)-verified self-report of continuous abstinence from smoking
Outcome measures
| Measure |
Placebo
n=601 Participants
Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions
|
Nicotine
n=597 Participants
Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions
|
|---|---|---|
|
Percentage of Participants With Continuous Smoking Abstinence From Week 2 to Week 26
|
1.2 Percentage of Participants
|
3.4 Percentage of Participants
|
SECONDARY outcome
Timeframe: Week 2 to Week 4Population: Analysis was based on the Full Analysis Set which included all randomized participants.
Percentage of participants with carbon monoxide (CO)-verified self-report of continuous abstinence from smoking
Outcome measures
| Measure |
Placebo
n=601 Participants
Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions
|
Nicotine
n=597 Participants
Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions
|
|---|---|---|
|
Percentage of Participants With Continuous Smoking Abstinence From Week 2 to Week 4
|
4.0 Percentage of Participants
|
6.7 Percentage of Participants
|
SECONDARY outcome
Timeframe: Week 2 to Week 8Population: Analysis was based on the Full Analysis Set which included all randomized participants.
Percentage of participants with carbon monoxide (CO)-verified self-report of continuous abstinence from smoking
Outcome measures
| Measure |
Placebo
n=601 Participants
Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions
|
Nicotine
n=597 Participants
Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions
|
|---|---|---|
|
Percentage of Participants With Continuous Smoking Abstinence From Week 2 to Week 8
|
2.2 Percentage of Participants
|
4.5 Percentage of Participants
|
SECONDARY outcome
Timeframe: Week 2 to Week 16Population: Analysis was based on the Full Analysis Set which included all randomized participants.
Percentage of participants with carbon monoxide (CO)-verified self-report of continuous abstinence from smoking
Outcome measures
| Measure |
Placebo
n=601 Participants
Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions
|
Nicotine
n=597 Participants
Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions
|
|---|---|---|
|
Percentage of Participants With Continuous Smoking Abstinence From Week 2 to Week 16
|
1.3 Percentage of Participants
|
3.9 Percentage of Participants
|
SECONDARY outcome
Timeframe: Week 2 to Week 20Population: Analysis was based on the Full Analysis Set which included all randomized participants.
Percentage of participants with carbon monoxide (CO)-verified self-report of continuous abstinence from smoking
Outcome measures
| Measure |
Placebo
n=601 Participants
Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions
|
Nicotine
n=597 Participants
Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions
|
|---|---|---|
|
Percentage of Participants With Continuous Smoking Abstinence From Week 2 to Week 20
|
1.3 Percentage of Participants
|
3.5 Percentage of Participants
|
SECONDARY outcome
Timeframe: Week 1Population: Analysis was based on randomized participants verified abstinent from smoking since the last visit.
Participants were asked if during the last 24 hours they experienced the desire/urge to smoke on a 5-grade categorical scale of 0 - 4 (where 0=not at all and 4=extremely so).
Outcome measures
| Measure |
Placebo
n=21 Participants
Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions
|
Nicotine
n=39 Participants
Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions
|
|---|---|---|
|
Percentage Distribution of the Rating of Desire/Urge to Smoke on a Categorical Scale at Week 1
Not at all (0)
|
9.5 Percentage of Participants
|
12.8 Percentage of Participants
|
|
Percentage Distribution of the Rating of Desire/Urge to Smoke on a Categorical Scale at Week 1
Somewhat (1)
|
33.3 Percentage of Participants
|
35.9 Percentage of Participants
|
|
Percentage Distribution of the Rating of Desire/Urge to Smoke on a Categorical Scale at Week 1
Moderately so (2)
|
33.3 Percentage of Participants
|
25.6 Percentage of Participants
|
|
Percentage Distribution of the Rating of Desire/Urge to Smoke on a Categorical Scale at Week 1
Very much so (3)
|
19.0 Percentage of Participants
|
15.4 Percentage of Participants
|
|
Percentage Distribution of the Rating of Desire/Urge to Smoke on a Categorical Scale at Week 1
Extremely so (4)
|
4.8 Percentage of Participants
|
10.3 Percentage of Participants
|
SECONDARY outcome
Timeframe: Week 2Population: Analysis was based on randomized participants verified abstinent from smoking since the last visit.
Participants were asked if during the last 24 hours they experienced the desire/urge to smoke on a 5-grade categorical scale of 0 - 4 (where 0=not at all and 4=extremely so).
Outcome measures
| Measure |
Placebo
n=25 Participants
Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions
|
Nicotine
n=58 Participants
Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions
|
|---|---|---|
|
Percentage Distribution of the Rating of Desire/Urge to Smoke on a Categorical Scale at Week 2
Not at all (0)
|
24.0 Percentage of Participants
|
15.5 Percentage of Participants
|
|
Percentage Distribution of the Rating of Desire/Urge to Smoke on a Categorical Scale at Week 2
Somewhat (1)
|
28.0 Percentage of Participants
|
36.2 Percentage of Participants
|
|
Percentage Distribution of the Rating of Desire/Urge to Smoke on a Categorical Scale at Week 2
Moderately so (2)
|
20.0 Percentage of Participants
|
34.5 Percentage of Participants
|
|
Percentage Distribution of the Rating of Desire/Urge to Smoke on a Categorical Scale at Week 2
Very much so (3)
|
20.0 Percentage of Participants
|
10.3 Percentage of Participants
|
|
Percentage Distribution of the Rating of Desire/Urge to Smoke on a Categorical Scale at Week 2
Extremely so (4)
|
8.0 Percentage of Participants
|
3.4 Percentage of Participants
|
SECONDARY outcome
Timeframe: Week 4Population: Analysis was based on randomized participants verified abstinent from smoking since the last visit.
Participants were asked if during the last 24 hours they experienced the desire/urge to smoke on a 5-grade categorical scale of 0 - 4 (where 0=not at all and 4=extremely so).
Outcome measures
| Measure |
Placebo
n=26 Participants
Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions
|
Nicotine
n=43 Participants
Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions
|
|---|---|---|
|
Percentage Distribution of the Rating of Desire/Urge to Smoke on a Categorical Scale at Week 4
Not at all (0)
|
19.2 Percentage of Participants
|
37.2 Percentage of Participants
|
|
Percentage Distribution of the Rating of Desire/Urge to Smoke on a Categorical Scale at Week 4
Somewhat (1)
|
53.8 Percentage of Participants
|
39.5 Percentage of Participants
|
|
Percentage Distribution of the Rating of Desire/Urge to Smoke on a Categorical Scale at Week 4
Moderately so (2)
|
23.1 Percentage of Participants
|
16.3 Percentage of Participants
|
|
Percentage Distribution of the Rating of Desire/Urge to Smoke on a Categorical Scale at Week 4
Very much so (3)
|
3.8 Percentage of Participants
|
7.0 Percentage of Participants
|
|
Percentage Distribution of the Rating of Desire/Urge to Smoke on a Categorical Scale at Week 4
Extremely so (4)
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
SECONDARY outcome
Timeframe: Week 6Population: Analysis was based on randomized participants verified abstinent from smoking since the last visit.
Participants were asked if during the last 24 hours they experienced the desire/urge to smoke on a 5-grade categorical scale of 0 - 4 (where 0=not at all and 4=extremely so).
Outcome measures
| Measure |
Placebo
n=32 Participants
Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions
|
Nicotine
n=54 Participants
Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions
|
|---|---|---|
|
Percentage Distribution of the Rating of Desire/Urge to Smoke on a Categorical Scale at Week 6
Not at all (0)
|
43.8 Percentage of Participants
|
31.5 Percentage of Participants
|
|
Percentage Distribution of the Rating of Desire/Urge to Smoke on a Categorical Scale at Week 6
Somewhat (1)
|
31.3 Percentage of Participants
|
42.6 Percentage of Participants
|
|
Percentage Distribution of the Rating of Desire/Urge to Smoke on a Categorical Scale at Week 6
Moderately so (2)
|
12.5 Percentage of Participants
|
18.5 Percentage of Participants
|
|
Percentage Distribution of the Rating of Desire/Urge to Smoke on a Categorical Scale at Week 6
Very much so (3)
|
9.4 Percentage of Participants
|
3.7 Percentage of Participants
|
|
Percentage Distribution of the Rating of Desire/Urge to Smoke on a Categorical Scale at Week 6
Extremely so (4)
|
3.1 Percentage of Participants
|
3.7 Percentage of Participants
|
SECONDARY outcome
Timeframe: Week 1Population: Analysis was based on randomized participants verified abstinent from smoking since the last visit.
Participants were asked if during the last 24 hours they experienced irritability/frustration/anger on a 5-grade categorical scale of 0 - 4 (where 0=not at all and 4=extremely so).
Outcome measures
| Measure |
Placebo
n=21 Participants
Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions
|
Nicotine
n=39 Participants
Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions
|
|---|---|---|
|
Percentage Distribution of the Rating of Irritability/Frustration/Anger on a Categorical Scale at Week 1
Moderately so (2)
|
19.0 Percentage of Participants
|
15.4 Percentage of Participants
|
|
Percentage Distribution of the Rating of Irritability/Frustration/Anger on a Categorical Scale at Week 1
Not at all (0)
|
38.1 Percentage of Participants
|
51.3 Percentage of Participants
|
|
Percentage Distribution of the Rating of Irritability/Frustration/Anger on a Categorical Scale at Week 1
Somewhat (1)
|
38.1 Percentage of Participants
|
28.2 Percentage of Participants
|
|
Percentage Distribution of the Rating of Irritability/Frustration/Anger on a Categorical Scale at Week 1
Very much so (3)
|
4.8 Percentage of Participants
|
0.0 Percentage of Participants
|
|
Percentage Distribution of the Rating of Irritability/Frustration/Anger on a Categorical Scale at Week 1
Extremely so (4)
|
0.0 Percentage of Participants
|
5.1 Percentage of Participants
|
SECONDARY outcome
Timeframe: Week 2Population: Analysis was based on randomized participants verified abstinent from smoking since the last visit.
Participants were asked if during the last 24 hours they experienced irritability/frustration/anger on a 5-grade categorical scale of 0 - 4 (where 0=not at all and 4=extremely so).
Outcome measures
| Measure |
Placebo
n=25 Participants
Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions
|
Nicotine
n=58 Participants
Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions
|
|---|---|---|
|
Percentage Distribution of the Rating of Irritability/Frustration/Anger on a Categorical Scale at Week 2
Not at all (0)
|
28.0 Percentage of Participants
|
56.9 Percentage of Participants
|
|
Percentage Distribution of the Rating of Irritability/Frustration/Anger on a Categorical Scale at Week 2
Moderately so (2)
|
12.0 Percentage of Participants
|
8.6 Percentage of Participants
|
|
Percentage Distribution of the Rating of Irritability/Frustration/Anger on a Categorical Scale at Week 2
Somewhat (1)
|
40.0 Percentage of Participants
|
24.1 Percentage of Participants
|
|
Percentage Distribution of the Rating of Irritability/Frustration/Anger on a Categorical Scale at Week 2
Very much so (3)
|
8.0 Percentage of Participants
|
5.2 Percentage of Participants
|
|
Percentage Distribution of the Rating of Irritability/Frustration/Anger on a Categorical Scale at Week 2
Extremely so (4)
|
12.0 Percentage of Participants
|
5.2 Percentage of Participants
|
SECONDARY outcome
Timeframe: Week 4Population: Analysis was based on randomized participants verified abstinent from smoking since the last visit.
Participants were asked if during the last 24 hours they experienced irritability/frustration/anger on a 5-grade categorical scale of 0 - 4 (where 0=not at all and 4=extremely so).
Outcome measures
| Measure |
Placebo
n=26 Participants
Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions
|
Nicotine
n=43 Participants
Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions
|
|---|---|---|
|
Percentage Distribution of the Rating of Irritability/Frustration/Anger on a Categorical Scale at Week 4
Not at all (0)
|
46.2 Percentage of Participants
|
55.8 Percentage of Participants
|
|
Percentage Distribution of the Rating of Irritability/Frustration/Anger on a Categorical Scale at Week 4
Somewhat (1)
|
34.6 Percentage of Participants
|
23.3 Percentage of Participants
|
|
Percentage Distribution of the Rating of Irritability/Frustration/Anger on a Categorical Scale at Week 4
Moderately so (2)
|
15.4 Percentage of Participants
|
11.6 Percentage of Participants
|
|
Percentage Distribution of the Rating of Irritability/Frustration/Anger on a Categorical Scale at Week 4
Very much so (3)
|
3.8 Percentage of Participants
|
7.0 Percentage of Participants
|
|
Percentage Distribution of the Rating of Irritability/Frustration/Anger on a Categorical Scale at Week 4
Extremely so (4)
|
0.0 Percentage of Participants
|
2.3 Percentage of Participants
|
SECONDARY outcome
Timeframe: Week 6Population: Analysis was based on randomized participants verified abstinent from smoking since the last visit.
Participants were asked if during the last 24 hours they experienced irritability/frustration/anger on a 5-grade categorical scale of 0 - 4 (where 0=not at all and 4=extremely so).
Outcome measures
| Measure |
Placebo
n=32 Participants
Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions
|
Nicotine
n=54 Participants
Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions
|
|---|---|---|
|
Percentage Distribution of the Rating of Irritability/Frustration/Anger on a Categorical Scale at Week 6
Very much so (3)
|
6.3 Percentage of Participants
|
3.7 Percentage of Participants
|
|
Percentage Distribution of the Rating of Irritability/Frustration/Anger on a Categorical Scale at Week 6
Not at all (0)
|
43.8 Percentage of Participants
|
61.1 Percentage of Participants
|
|
Percentage Distribution of the Rating of Irritability/Frustration/Anger on a Categorical Scale at Week 6
Somewhat (1)
|
43.8 Percentage of Participants
|
20.4 Percentage of Participants
|
|
Percentage Distribution of the Rating of Irritability/Frustration/Anger on a Categorical Scale at Week 6
Moderately so (2)
|
6.3 Percentage of Participants
|
13.0 Percentage of Participants
|
|
Percentage Distribution of the Rating of Irritability/Frustration/Anger on a Categorical Scale at Week 6
Extremely so (4)
|
0.0 Percentage of Participants
|
1.9 Percentage of Participants
|
SECONDARY outcome
Timeframe: Week 1Population: Analysis was based on randomized participants verified abstinent from smoking since the last visit.
Participants were asked if during the last 24 hours they experienced restlessness on a 5-grade categorical scale of 0 - 4 (where 0=not at all and 4=extremely so).
Outcome measures
| Measure |
Placebo
n=21 Participants
Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions
|
Nicotine
n=39 Participants
Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions
|
|---|---|---|
|
Percentage Distribution of the Rating of Restlessness on a Categorical Scale at Week 1
Extremely so (4)
|
4.8 Percentage of Participants
|
2.6 Percentage of Participants
|
|
Percentage Distribution of the Rating of Restlessness on a Categorical Scale at Week 1
Not at all (0)
|
47.6 Percentage of Participants
|
43.6 Percentage of Participants
|
|
Percentage Distribution of the Rating of Restlessness on a Categorical Scale at Week 1
Somewhat (1)
|
14.3 Percentage of Participants
|
30.8 Percentage of Participants
|
|
Percentage Distribution of the Rating of Restlessness on a Categorical Scale at Week 1
Moderately so (2)
|
23.8 Percentage of Participants
|
17.9 Percentage of Participants
|
|
Percentage Distribution of the Rating of Restlessness on a Categorical Scale at Week 1
Very much so (3)
|
9.5 Percentage of Participants
|
5.1 Percentage of Participants
|
SECONDARY outcome
Timeframe: Week 2Population: Analysis was based on randomized participants verified abstinent from smoking since the last visit.
Participants were asked if during the last 24 hours they experienced restlessness on a 5-grade categorical scale of 0 - 4 (where 0=not at all and 4=extremely so).
Outcome measures
| Measure |
Placebo
n=25 Participants
Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions
|
Nicotine
n=58 Participants
Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions
|
|---|---|---|
|
Percentage Distribution of the Rating of Restlessness on a Categorical Scale at Week 2
Extremely so (4)
|
4.0 Percentage of Participants
|
1.7 Percentage of Participants
|
|
Percentage Distribution of the Rating of Restlessness on a Categorical Scale at Week 2
Not at all (0)
|
40.0 Percentage of Participants
|
58.6 Percentage of Participants
|
|
Percentage Distribution of the Rating of Restlessness on a Categorical Scale at Week 2
Somewhat (1)
|
32.0 Percentage of Participants
|
20.7 Percentage of Participants
|
|
Percentage Distribution of the Rating of Restlessness on a Categorical Scale at Week 2
Moderately so (2)
|
12.0 Percentage of Participants
|
17.2 Percentage of Participants
|
|
Percentage Distribution of the Rating of Restlessness on a Categorical Scale at Week 2
Very much so (3)
|
12.0 Percentage of Participants
|
1.7 Percentage of Participants
|
SECONDARY outcome
Timeframe: Week 4Population: Analysis was based on randomized participants verified abstinent from smoking since the last visit.
Participants were asked if during the last 24 hours they experienced restlessness on a 5-grade categorical scale of 0 - 4 (where 0=not at all and 4=extremely so).
Outcome measures
| Measure |
Placebo
n=26 Participants
Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions
|
Nicotine
n=43 Participants
Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions
|
|---|---|---|
|
Percentage Distribution of the Rating of Restlessness on a Categorical Scale at Week 4
Not at all (0)
|
53.8 Percentage of Participants
|
62.8 Percentage of Participants
|
|
Percentage Distribution of the Rating of Restlessness on a Categorical Scale at Week 4
Somewhat (1)
|
34.6 Percentage of Participants
|
32.6 Percentage of Participants
|
|
Percentage Distribution of the Rating of Restlessness on a Categorical Scale at Week 4
Moderately so (2)
|
11.5 Percentage of Participants
|
2.3 Percentage of Participants
|
|
Percentage Distribution of the Rating of Restlessness on a Categorical Scale at Week 4
Very much so (3)
|
0.0 Percentage of Participants
|
2.3 Percentage of Participants
|
|
Percentage Distribution of the Rating of Restlessness on a Categorical Scale at Week 4
Extremely so (4)
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
SECONDARY outcome
Timeframe: Week 6Population: Analysis was based on randomized participants verified abstinent from smoking since the last visit.
Participants were asked if during the last 24 hours they experienced restlessness on a 5-grade categorical scale of 0 - 4 (where 0=not at all and 4=extremely so).
Outcome measures
| Measure |
Placebo
n=32 Participants
Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions
|
Nicotine
n=54 Participants
Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions
|
|---|---|---|
|
Percentage Distribution of the Rating of Restlessness on a Categorical Scale at Week 6
Moderately so (2)
|
9.4 Percentage of Participants
|
11.1 Percentage of Participants
|
|
Percentage Distribution of the Rating of Restlessness on a Categorical Scale at Week 6
Very much so (3)
|
6.3 Percentage of Participants
|
1.9 Percentage of Participants
|
|
Percentage Distribution of the Rating of Restlessness on a Categorical Scale at Week 6
Extremely so (4)
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
|
Percentage Distribution of the Rating of Restlessness on a Categorical Scale at Week 6
Not at all (0)
|
46.9 Percentage of Participants
|
63.0 Percentage of Participants
|
|
Percentage Distribution of the Rating of Restlessness on a Categorical Scale at Week 6
Somewhat (1)
|
37.5 Percentage of Participants
|
24.1 Percentage of Participants
|
SECONDARY outcome
Timeframe: Week 1Population: Analysis was based on randomized participants verified abstinent from smoking since the last visit.
Participants were asked if during the last 24 hours they experienced difficulty concentrating on a 5-grade categorical scale of 0 - 4 (where 0=not at all and 4=extremely so).
Outcome measures
| Measure |
Placebo
n=21 Participants
Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions
|
Nicotine
n=39 Participants
Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions
|
|---|---|---|
|
Percentage Distribution of the Rating of Difficulty Concentrating on a Categorical Scale at Week 1
Extremely so (4)
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
|
Percentage Distribution of the Rating of Difficulty Concentrating on a Categorical Scale at Week 1
Not at all (0)
|
66.7 Percentage of Participants
|
69.2 Percentage of Participants
|
|
Percentage Distribution of the Rating of Difficulty Concentrating on a Categorical Scale at Week 1
Somewhat (1)
|
23.8 Percentage of Participants
|
17.9 Percentage of Participants
|
|
Percentage Distribution of the Rating of Difficulty Concentrating on a Categorical Scale at Week 1
Moderately so (2)
|
4.8 Percentage of Participants
|
7.7 Percentage of Participants
|
|
Percentage Distribution of the Rating of Difficulty Concentrating on a Categorical Scale at Week 1
Very much so (3)
|
4.8 Percentage of Participants
|
5.1 Percentage of Participants
|
SECONDARY outcome
Timeframe: Week 2Population: Analysis was based on randomized participants verified abstinent from smoking since the last visit.
Participants were asked if during the last 24 hours they experienced difficulty concentrating on a 5-grade categorical scale of 0 - 4 (where 0=not at all and 4=extremely so).
Outcome measures
| Measure |
Placebo
n=25 Participants
Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions
|
Nicotine
n=58 Participants
Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions
|
|---|---|---|
|
Percentage Distribution of the Rating of Difficulty Concentrating on a Categorical Scale at Week 2
Not at all (0)
|
52.0 Percentage of Participants
|
63.8 Percentage of Participants
|
|
Percentage Distribution of the Rating of Difficulty Concentrating on a Categorical Scale at Week 2
Extremely so (4)
|
4.0 Percentage of Participants
|
1.7 Percentage of Participants
|
|
Percentage Distribution of the Rating of Difficulty Concentrating on a Categorical Scale at Week 2
Somewhat (1)
|
32.0 Percentage of Participants
|
24.1 Percentage of Participants
|
|
Percentage Distribution of the Rating of Difficulty Concentrating on a Categorical Scale at Week 2
Moderately so (2)
|
8.0 Percentage of Participants
|
6.9 Percentage of Participants
|
|
Percentage Distribution of the Rating of Difficulty Concentrating on a Categorical Scale at Week 2
Very much so (3)
|
4.0 Percentage of Participants
|
3.4 Percentage of Participants
|
SECONDARY outcome
Timeframe: Week 4Population: Analysis was based on randomized participants verified abstinent from smoking since the last visit.
Participants were asked if during the last 24 hours they experienced difficulty concentrating on a 5-grade categorical scale of 0 - 4 (where 0=not at all and 4=extremely so).
Outcome measures
| Measure |
Placebo
n=26 Participants
Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions
|
Nicotine
n=43 Participants
Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions
|
|---|---|---|
|
Percentage Distribution of the Rating of Difficulty Concentrating on a Categorical Scale at Week 4
Not at all (0)
|
73.1 Percentage of Participants
|
74.4 Percentage of Participants
|
|
Percentage Distribution of the Rating of Difficulty Concentrating on a Categorical Scale at Week 4
Somewhat (1)
|
23.1 Percentage of Participants
|
11.6 Percentage of Participants
|
|
Percentage Distribution of the Rating of Difficulty Concentrating on a Categorical Scale at Week 4
Moderately so (2)
|
3.8 Percentage of Participants
|
9.3 Percentage of Participants
|
|
Percentage Distribution of the Rating of Difficulty Concentrating on a Categorical Scale at Week 4
Very much so (3)
|
0.0 Percentage of Participants
|
4.7 Percentage of Participants
|
|
Percentage Distribution of the Rating of Difficulty Concentrating on a Categorical Scale at Week 4
Extremely so (4)
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
SECONDARY outcome
Timeframe: Week 6Population: Analysis was based on randomized participants verified abstinent from smoking since the last visit.
Participants were asked if during the last 24 hours they experienced difficulty concentrating on a 5-grade categorical scale of 0 - 4 (where 0=not at all and 4=extremely so).
Outcome measures
| Measure |
Placebo
n=32 Participants
Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions
|
Nicotine
n=54 Participants
Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions
|
|---|---|---|
|
Percentage Distribution of the Rating of Difficulty Concentrating on a Categorical Scale at Week 6
Not at all (0)
|
71.9 Percentage of Participants
|
74.1 Percentage of Participants
|
|
Percentage Distribution of the Rating of Difficulty Concentrating on a Categorical Scale at Week 6
Somewhat (1)
|
12.5 Percentage of Participants
|
16.7 Percentage of Participants
|
|
Percentage Distribution of the Rating of Difficulty Concentrating on a Categorical Scale at Week 6
Moderately so (2)
|
9.4 Percentage of Participants
|
5.6 Percentage of Participants
|
|
Percentage Distribution of the Rating of Difficulty Concentrating on a Categorical Scale at Week 6
Very much so (3)
|
6.3 Percentage of Participants
|
3.7 Percentage of Participants
|
|
Percentage Distribution of the Rating of Difficulty Concentrating on a Categorical Scale at Week 6
Extremely so (4)
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
SECONDARY outcome
Timeframe: Week 1Population: Analysis was based on randomized participants verified abstinent from smoking since the last visit.
Participants were asked if during the last 24 hours they experienced anxiety on a 5-grade categorical scale of 0 - 4 (where 0=not at all and 4=extremely so).
Outcome measures
| Measure |
Placebo
n=21 Participants
Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions
|
Nicotine
n=39 Participants
Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions
|
|---|---|---|
|
Percentage Distribution of the Rating of Anxiety on a Categorical Scale at Week 1
Not at all (0)
|
52.4 Percentage of Participants
|
59.0 Percentage of Participants
|
|
Percentage Distribution of the Rating of Anxiety on a Categorical Scale at Week 1
Somewhat (1)
|
28.6 Percentage of Participants
|
28.2 Percentage of Participants
|
|
Percentage Distribution of the Rating of Anxiety on a Categorical Scale at Week 1
Moderately so (2)
|
19.0 Percentage of Participants
|
7.7 Percentage of Participants
|
|
Percentage Distribution of the Rating of Anxiety on a Categorical Scale at Week 1
Very much so (3)
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
|
Percentage Distribution of the Rating of Anxiety on a Categorical Scale at Week 1
Extremely so (4)
|
0.0 Percentage of Participants
|
5.1 Percentage of Participants
|
SECONDARY outcome
Timeframe: Week 2Population: Analysis was based on randomized participants verified abstinent from smoking since the last visit.
Participants were asked if during the last 24 hours they experienced anxiety on a 5-grade categorical scale of 0 - 4 (where 0=not at all and 4=extremely so).
Outcome measures
| Measure |
Placebo
n=25 Participants
Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions
|
Nicotine
n=58 Participants
Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions
|
|---|---|---|
|
Percentage Distribution of the Rating of Anxiety on a Categorical Scale at Week 2
Not at all (0)
|
44.0 Percentage of Participants
|
72.4 Percentage of Participants
|
|
Percentage Distribution of the Rating of Anxiety on a Categorical Scale at Week 2
Somewhat (1)
|
24.0 Percentage of Participants
|
12.1 Percentage of Participants
|
|
Percentage Distribution of the Rating of Anxiety on a Categorical Scale at Week 2
Moderately so (2)
|
12.0 Percentage of Participants
|
8.6 Percentage of Participants
|
|
Percentage Distribution of the Rating of Anxiety on a Categorical Scale at Week 2
Very much so (3)
|
12.0 Percentage of Participants
|
3.4 Percentage of Participants
|
|
Percentage Distribution of the Rating of Anxiety on a Categorical Scale at Week 2
Extremely so (4)
|
8.0 Percentage of Participants
|
3.4 Percentage of Participants
|
SECONDARY outcome
Timeframe: Week 4Population: Analysis was based on randomized participants verified abstinent from smoking since the last visit.
Participants were asked if during the last 24 hours they experienced anxiety on a 5-grade categorical scale of 0 - 4 (where 0=not at all and 4=extremely so).
Outcome measures
| Measure |
Placebo
n=26 Participants
Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions
|
Nicotine
n=43 Participants
Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions
|
|---|---|---|
|
Percentage Distribution of the Rating of Anxiety on a Categorical Scale at Week 4
Not at all (0)
|
65.4 Percentage of Participants
|
65.1 Percentage of Participants
|
|
Percentage Distribution of the Rating of Anxiety on a Categorical Scale at Week 4
Somewhat (1)
|
26.9 Percentage of Participants
|
23.3 Percentage of Participants
|
|
Percentage Distribution of the Rating of Anxiety on a Categorical Scale at Week 4
Moderately so (2)
|
7.7 Percentage of Participants
|
11.6 Percentage of Participants
|
|
Percentage Distribution of the Rating of Anxiety on a Categorical Scale at Week 4
Very much so (3)
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
|
Percentage Distribution of the Rating of Anxiety on a Categorical Scale at Week 4
Extremely so (4)
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
SECONDARY outcome
Timeframe: Week 6Population: Analysis was based on randomized participants verified abstinent from smoking since the last visit.
Participants were asked if during the last 24 hours they experienced anxiety on a 5-grade categorical scale of 0 - 4 (where 0=not at all and 4=extremely so).
Outcome measures
| Measure |
Placebo
n=32 Participants
Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions
|
Nicotine
n=54 Participants
Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions
|
|---|---|---|
|
Percentage Distribution of the Rating of Anxiety on a Categorical Scale at Week 6
Very much so (3)
|
6.3 Percentage of Participants
|
3.7 Percentage of Participants
|
|
Percentage Distribution of the Rating of Anxiety on a Categorical Scale at Week 6
Not at all (0)
|
62.5 Percentage of Participants
|
66.7 Percentage of Participants
|
|
Percentage Distribution of the Rating of Anxiety on a Categorical Scale at Week 6
Somewhat (1)
|
25.0 Percentage of Participants
|
20.4 Percentage of Participants
|
|
Percentage Distribution of the Rating of Anxiety on a Categorical Scale at Week 6
Moderately so (2)
|
6.3 Percentage of Participants
|
9.3 Percentage of Participants
|
|
Percentage Distribution of the Rating of Anxiety on a Categorical Scale at Week 6
Extremely so (4)
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
SECONDARY outcome
Timeframe: Week 1Population: Analysis was based on randomized participants verified abstinent from smoking since the last visit.
Participants were asked if during the last 24 hours they experienced dysphoric or depressed mood on a 5-grade categorical scale of 0 - 4 (where 0=not at all and 4=extremely so).
Outcome measures
| Measure |
Placebo
n=21 Participants
Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions
|
Nicotine
n=39 Participants
Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions
|
|---|---|---|
|
Percentage Distribution of the Rating of Dysphoric or Depressed Mood on a Categorical Scale at Week 1
Not at all (0)
|
81.0 Percentage of Participants
|
87.2 Percentage of Participants
|
|
Percentage Distribution of the Rating of Dysphoric or Depressed Mood on a Categorical Scale at Week 1
Somewhat (1)
|
19.0 Percentage of Participants
|
5.1 Percentage of Participants
|
|
Percentage Distribution of the Rating of Dysphoric or Depressed Mood on a Categorical Scale at Week 1
Moderately so (2)
|
0.0 Percentage of Participants
|
5.1 Percentage of Participants
|
|
Percentage Distribution of the Rating of Dysphoric or Depressed Mood on a Categorical Scale at Week 1
Very much so (3)
|
0.0 Percentage of Participants
|
2.6 Percentage of Participants
|
|
Percentage Distribution of the Rating of Dysphoric or Depressed Mood on a Categorical Scale at Week 1
Extremely so (4)
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
SECONDARY outcome
Timeframe: Week 2Population: Analysis was based on randomized participants verified abstinent from smoking since the last visit.
Participants were asked if during the last 24 hours they experienced dysphoric or depressed mood on a 5-grade categorical scale of 0 - 4 (where 0=not at all and 4=extremely so).
Outcome measures
| Measure |
Placebo
n=25 Participants
Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions
|
Nicotine
n=58 Participants
Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions
|
|---|---|---|
|
Percentage Distribution of the Rating of Dysphoric or Depressed Mood on a Categorical Scale at Week 2
Somewhat (1)
|
20.0 Percentage of Participants
|
5.2 Percentage of Participants
|
|
Percentage Distribution of the Rating of Dysphoric or Depressed Mood on a Categorical Scale at Week 2
Very much so (3)
|
0.0 Percentage of Participants
|
1.7 Percentage of Participants
|
|
Percentage Distribution of the Rating of Dysphoric or Depressed Mood on a Categorical Scale at Week 2
Not at all (0)
|
72.0 Percentage of Participants
|
84.5 Percentage of Participants
|
|
Percentage Distribution of the Rating of Dysphoric or Depressed Mood on a Categorical Scale at Week 2
Moderately so (2)
|
8.0 Percentage of Participants
|
6.9 Percentage of Participants
|
|
Percentage Distribution of the Rating of Dysphoric or Depressed Mood on a Categorical Scale at Week 2
Extremely so (4)
|
0.0 Percentage of Participants
|
1.7 Percentage of Participants
|
SECONDARY outcome
Timeframe: Week 4Population: Analysis was based on randomized participants verified abstinent from smoking since the last visit.
Participants were asked if during the last 24 hours they experienced dysphoric or depressed mood on a 5-grade categorical scale of 0 - 4 (where 0=not at all and 4=extremely so).
Outcome measures
| Measure |
Placebo
n=26 Participants
Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions
|
Nicotine
n=43 Participants
Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions
|
|---|---|---|
|
Percentage Distribution of the Rating of Dysphoric or Depressed Mood on a Categorical Scale at Week 4
Somewhat (1)
|
11.5 Percentage of Participants
|
9.3 Percentage of Participants
|
|
Percentage Distribution of the Rating of Dysphoric or Depressed Mood on a Categorical Scale at Week 4
Not at all (0)
|
84.6 Percentage of Participants
|
86.0 Percentage of Participants
|
|
Percentage Distribution of the Rating of Dysphoric or Depressed Mood on a Categorical Scale at Week 4
Moderately so (2)
|
0.0 Percentage of Participants
|
2.3 Percentage of Participants
|
|
Percentage Distribution of the Rating of Dysphoric or Depressed Mood on a Categorical Scale at Week 4
Very much so (3)
|
0.0 Percentage of Participants
|
2.3 Percentage of Participants
|
|
Percentage Distribution of the Rating of Dysphoric or Depressed Mood on a Categorical Scale at Week 4
Extremely so (4)
|
3.8 Percentage of Participants
|
0.0 Percentage of Participants
|
SECONDARY outcome
Timeframe: Week 6Population: Analysis was based on randomized participants verified abstinent from smoking since the last visit.
Participants were asked if during the last 24 hours they experienced dysphoric or depressed mood on a 5-grade categorical scale of 0 - 4 (where 0=not at all and 4=extremely so).
Outcome measures
| Measure |
Placebo
n=32 Participants
Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions
|
Nicotine
n=54 Participants
Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions
|
|---|---|---|
|
Percentage Distribution of the Rating of Dysphoric or Depressed Mood on a Categorical Scale at Week 6
Not at all (0)
|
78.1 Percentage of Participants
|
75.9 Percentage of Participants
|
|
Percentage Distribution of the Rating of Dysphoric or Depressed Mood on a Categorical Scale at Week 6
Somewhat (1)
|
15.6 Percentage of Participants
|
16.7 Percentage of Participants
|
|
Percentage Distribution of the Rating of Dysphoric or Depressed Mood on a Categorical Scale at Week 6
Moderately so (2)
|
3.1 Percentage of Participants
|
5.6 Percentage of Participants
|
|
Percentage Distribution of the Rating of Dysphoric or Depressed Mood on a Categorical Scale at Week 6
Very much so (3)
|
3.1 Percentage of Participants
|
1.9 Percentage of Participants
|
|
Percentage Distribution of the Rating of Dysphoric or Depressed Mood on a Categorical Scale at Week 6
Extremely so (4)
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
SECONDARY outcome
Timeframe: Week 1Population: Analysis was based on randomized participants verified abstinent from smoking since the last visit.
Participants were asked if during the last 24 hours they experienced insomnia on a 5-grade categorical scale of 0 - 4 (where 0=not at all and 4=extremely so).
Outcome measures
| Measure |
Placebo
n=21 Participants
Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions
|
Nicotine
n=39 Participants
Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions
|
|---|---|---|
|
Percentage Distribution of the Rating of Insomnia on a Categorical Scale at Week 1
Not at all (0)
|
76.2 Percentage of Participants
|
79.5 Percentage of Participants
|
|
Percentage Distribution of the Rating of Insomnia on a Categorical Scale at Week 1
Somewhat (1)
|
14.3 Percentage of Participants
|
12.8 Percentage of Participants
|
|
Percentage Distribution of the Rating of Insomnia on a Categorical Scale at Week 1
Moderately so (2)
|
9.5 Percentage of Participants
|
2.6 Percentage of Participants
|
|
Percentage Distribution of the Rating of Insomnia on a Categorical Scale at Week 1
Very much so (3)
|
0.0 Percentage of Participants
|
5.1 Percentage of Participants
|
|
Percentage Distribution of the Rating of Insomnia on a Categorical Scale at Week 1
Extremely so (4)
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
SECONDARY outcome
Timeframe: Week 2Population: Analysis was based on randomized participants verified abstinent from smoking since the last visit.
Participants were asked if during the last 24 hours they experienced insomnia on a 5-grade categorical scale of 0 - 4 (where 0=not at all and 4=extremely so).
Outcome measures
| Measure |
Placebo
n=25 Participants
Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions
|
Nicotine
n=58 Participants
Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions
|
|---|---|---|
|
Percentage Distribution of the Rating of Insomnia on a Categorical Scale at Week 2
Not at all (0)
|
76.0 Percentage of Participants
|
67.2 Percentage of Participants
|
|
Percentage Distribution of the Rating of Insomnia on a Categorical Scale at Week 2
Somewhat (1)
|
16.0 Percentage of Participants
|
20.7 Percentage of Participants
|
|
Percentage Distribution of the Rating of Insomnia on a Categorical Scale at Week 2
Moderately so (2)
|
0.0 Percentage of Participants
|
5.2 Percentage of Participants
|
|
Percentage Distribution of the Rating of Insomnia on a Categorical Scale at Week 2
Very much so (3)
|
8.0 Percentage of Participants
|
5.2 Percentage of Participants
|
|
Percentage Distribution of the Rating of Insomnia on a Categorical Scale at Week 2
Extremely so (4)
|
0.0 Percentage of Participants
|
1.7 Percentage of Participants
|
SECONDARY outcome
Timeframe: Week 4Population: Analysis was based on randomized participants verified abstinent from smoking since the last visit.
Participants were asked if during the last 24 hours they experienced insomnia on a 5-grade categorical scale of 0 - 4 (where 0=not at all and 4=extremely so).
Outcome measures
| Measure |
Placebo
n=26 Participants
Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions
|
Nicotine
n=43 Participants
Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions
|
|---|---|---|
|
Percentage Distribution of the Rating of Insomnia on a Categorical Scale at Week 4
Not at all (0)
|
61.5 Percentage of Participants
|
69.8 Percentage of Participants
|
|
Percentage Distribution of the Rating of Insomnia on a Categorical Scale at Week 4
Somewhat (1)
|
26.9 Percentage of Participants
|
20.9 Percentage of Participants
|
|
Percentage Distribution of the Rating of Insomnia on a Categorical Scale at Week 4
Moderately so (2)
|
11.5 Percentage of Participants
|
7.0 Percentage of Participants
|
|
Percentage Distribution of the Rating of Insomnia on a Categorical Scale at Week 4
Very much so (3)
|
0.0 Percentage of Participants
|
2.3 Percentage of Participants
|
|
Percentage Distribution of the Rating of Insomnia on a Categorical Scale at Week 4
Extremely so (4)
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
SECONDARY outcome
Timeframe: Week 6Population: Analysis was based on randomized participants verified abstinent from smoking since the last visit.
Participants were asked if during the last 24 hours they experienced insomnia on a 5-grade categorical scale of 0 - 4 (where 0=not at all and 4=extremely so).
Outcome measures
| Measure |
Placebo
n=32 Participants
Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions
|
Nicotine
n=54 Participants
Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions
|
|---|---|---|
|
Percentage Distribution of the Rating of Insomnia on a Categorical Scale at Week 6
Not at all (0)
|
62.5 Percentage of Participants
|
83.3 Percentage of Participants
|
|
Percentage Distribution of the Rating of Insomnia on a Categorical Scale at Week 6
Somewhat (1)
|
21.9 Percentage of Participants
|
11.1 Percentage of Participants
|
|
Percentage Distribution of the Rating of Insomnia on a Categorical Scale at Week 6
Moderately so (2)
|
6.3 Percentage of Participants
|
3.7 Percentage of Participants
|
|
Percentage Distribution of the Rating of Insomnia on a Categorical Scale at Week 6
Very much so (3)
|
6.3 Percentage of Participants
|
1.9 Percentage of Participants
|
|
Percentage Distribution of the Rating of Insomnia on a Categorical Scale at Week 6
Extremely so (4)
|
3.1 Percentage of Participants
|
0.0 Percentage of Participants
|
SECONDARY outcome
Timeframe: Week 1Population: Analysis was based on randomized participants verified abstinent from smoking since the last visit.
Participants were asked if during the last 24 hours they experienced increased appetite on a 5-grade categorical scale of 0 - 4 (where 0=not at all and 4=extremely so).
Outcome measures
| Measure |
Placebo
n=21 Participants
Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions
|
Nicotine
n=39 Participants
Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions
|
|---|---|---|
|
Percentage Distribution of the Rating of Increased Appetite on a Categorical Scale at Week 1
Very much so (3)
|
14.3 Percentage of Participants
|
17.9 Percentage of Participants
|
|
Percentage Distribution of the Rating of Increased Appetite on a Categorical Scale at Week 1
Not at all (0)
|
9.5 Percentage of Participants
|
43.6 Percentage of Participants
|
|
Percentage Distribution of the Rating of Increased Appetite on a Categorical Scale at Week 1
Somewhat (1)
|
52.4 Percentage of Participants
|
28.2 Percentage of Participants
|
|
Percentage Distribution of the Rating of Increased Appetite on a Categorical Scale at Week 1
Moderately so (2)
|
23.8 Percentage of Participants
|
5.1 Percentage of Participants
|
|
Percentage Distribution of the Rating of Increased Appetite on a Categorical Scale at Week 1
Extremely so (4)
|
0.0 Percentage of Participants
|
5.1 Percentage of Participants
|
SECONDARY outcome
Timeframe: Week 2Population: Analysis was based on randomized participants verified abstinent from smoking since the last visit.
Participants were asked if during the last 24 hours they experienced increased appetite on a 5-grade categorical scale of 0 - 4 (where 0=not at all and 4=extremely so).
Outcome measures
| Measure |
Placebo
n=25 Participants
Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions
|
Nicotine
n=58 Participants
Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions
|
|---|---|---|
|
Percentage Distribution of the Rating of Increased Appetite on a Categorical Scale at Week 2
Not at all (0)
|
28.0 Percentage of Participants
|
41.4 Percentage of Participants
|
|
Percentage Distribution of the Rating of Increased Appetite on a Categorical Scale at Week 2
Somewhat (1)
|
36.0 Percentage of Participants
|
25.9 Percentage of Participants
|
|
Percentage Distribution of the Rating of Increased Appetite on a Categorical Scale at Week 2
Moderately so (2)
|
24.0 Percentage of Participants
|
12.1 Percentage of Participants
|
|
Percentage Distribution of the Rating of Increased Appetite on a Categorical Scale at Week 2
Very much so (3)
|
12.0 Percentage of Participants
|
17.2 Percentage of Participants
|
|
Percentage Distribution of the Rating of Increased Appetite on a Categorical Scale at Week 2
Extremely so (4)
|
0.0 Percentage of Participants
|
3.4 Percentage of Participants
|
SECONDARY outcome
Timeframe: Week 4Population: Analysis was based on randomized participants verified abstinent from smoking since the last visit.
Participants were asked if during the last 24 hours they experienced increased appetite on a 5-grade categorical scale of 0 - 4 (where 0=not at all and 4=extremely so).
Outcome measures
| Measure |
Placebo
n=26 Participants
Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions
|
Nicotine
n=43 Participants
Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions
|
|---|---|---|
|
Percentage Distribution of the Rating of Increased Appetite on a Categorical Scale at Week 4
Not at all (0)
|
30.8 Percentage of Participants
|
44.2 Percentage of Participants
|
|
Percentage Distribution of the Rating of Increased Appetite on a Categorical Scale at Week 4
Somewhat (1)
|
26.9 Percentage of Participants
|
30.2 Percentage of Participants
|
|
Percentage Distribution of the Rating of Increased Appetite on a Categorical Scale at Week 4
Moderately so (2)
|
23.1 Percentage of Participants
|
11.6 Percentage of Participants
|
|
Percentage Distribution of the Rating of Increased Appetite on a Categorical Scale at Week 4
Very much so (3)
|
15.4 Percentage of Participants
|
9.3 Percentage of Participants
|
|
Percentage Distribution of the Rating of Increased Appetite on a Categorical Scale at Week 4
Extremely so (4)
|
3.8 Percentage of Participants
|
4.7 Percentage of Participants
|
SECONDARY outcome
Timeframe: Week 6Population: Analysis was based on randomized participants verified abstinent from smoking since the last visit.
Participants were asked if during the last 24 hours they experienced increased appetite on a 5-grade categorical scale of 0 - 4 (where 0=not at all and 4=extremely so).
Outcome measures
| Measure |
Placebo
n=32 Participants
Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions
|
Nicotine
n=54 Participants
Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions
|
|---|---|---|
|
Percentage Distribution of the Rating of Increased Appetite on a Categorical Scale at Week 6
Somewhat (1)
|
43.8 Percentage of Participants
|
31.5 Percentage of Participants
|
|
Percentage Distribution of the Rating of Increased Appetite on a Categorical Scale at Week 6
Not at all (0)
|
21.9 Percentage of Participants
|
35.2 Percentage of Participants
|
|
Percentage Distribution of the Rating of Increased Appetite on a Categorical Scale at Week 6
Moderately so (2)
|
18.8 Percentage of Participants
|
14.8 Percentage of Participants
|
|
Percentage Distribution of the Rating of Increased Appetite on a Categorical Scale at Week 6
Very much so (3)
|
12.5 Percentage of Participants
|
14.8 Percentage of Participants
|
|
Percentage Distribution of the Rating of Increased Appetite on a Categorical Scale at Week 6
Extremely so (4)
|
3.1 Percentage of Participants
|
3.7 Percentage of Participants
|
SECONDARY outcome
Timeframe: Week 1Population: Analysis was based on randomized participants verified abstinent from smoking since the last visit.
Participants were asked if during the last 24 hours they experienced each of 7 withdrawal symptoms on a 5-grade categorical scale of 0 - 4 (where 0=not at all and 4=extremely so). The aggregated withdrawal symptom score was the sum of the scores of the 7 withdrawal symptoms (irritability-frustration-anger, restlessness, difficulty concentrating, anxiety, dysphoric or depressed mood, insomnia, and increased appetite). The total scores are reported with a minimum possible score of 0 and a maximum possible score of 28.
Outcome measures
| Measure |
Placebo
n=21 Participants
Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions
|
Nicotine
n=39 Participants
Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions
|
|---|---|---|
|
Aggregated Withdrawal Score at Week 1
|
5.1 units on a scale
Standard Deviation 4.25
|
4.5 units on a scale
Standard Deviation 4.20
|
SECONDARY outcome
Timeframe: Week 2Population: Analysis was based on randomized participants verified abstinent from smoking since the last visit.
Participants were asked if during the last 24 hours they experienced each of 7 withdrawal symptoms on a 5-grade categorical scale of 0 - 4 (where 0=not at all and 4=extremely so). The aggregated withdrawal symptom score was the sum of the scores of the 7 withdrawal symptoms (irritability-frustration-anger, restlessness, difficulty concentrating, anxiety, dysphoric or depressed mood, insomnia, and increased appetite). The total scores are reported with a minimum possible score of 0 and a maximum possible score of 28.
Outcome measures
| Measure |
Placebo
n=25 Participants
Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions
|
Nicotine
n=58 Participants
Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions
|
|---|---|---|
|
Aggregated Withdrawal Score at Week 2
|
6.3 units on a scale
Standard Deviation 5.46
|
4.5 units on a scale
Standard Deviation 5.02
|
SECONDARY outcome
Timeframe: Week 4Population: Analysis was based on randomized participants verified abstinent from smoking since the last visit.
Participants were asked if during the last 24 hours they experienced each of 7 withdrawal symptoms on a 5-grade categorical scale of 0 - 4 (where 0=not at all and 4=extremely so). The aggregated withdrawal symptom score was the sum of the scores of the 7 withdrawal symptoms (irritability-frustration-anger, restlessness, difficulty concentrating, anxiety, dysphoric or depressed mood, insomnia, and increased appetite). The total scores are reported with a minimum possible score of 0 and a maximum possible score of 28.
Outcome measures
| Measure |
Placebo
n=26 Participants
Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions
|
Nicotine
n=43 Participants
Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions
|
|---|---|---|
|
Aggregated Withdrawal Score at Week 4
|
4.2 units on a scale
Standard Deviation 3.53
|
3.7 units on a scale
Standard Deviation 3.77
|
SECONDARY outcome
Timeframe: Week 6Population: Analysis was based on randomized participants verified abstinent from smoking since the last visit.
Participants were asked if during the last 24 hours they experienced each of 7 withdrawal symptoms on a 5-grade categorical scale of 0 - 4 (where 0=not at all and 4=extremely so). The aggregated withdrawal symptom score was the sum of the scores of the 7 withdrawal symptoms (irritability-frustration-anger, restlessness, difficulty concentrating, anxiety, dysphoric or depressed mood, insomnia, and increased appetite). The total scores are reported with a minimum possible score of 0 and a maximum possible score of 28.
Outcome measures
| Measure |
Placebo
n=32 Participants
Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions
|
Nicotine
n=54 Participants
Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions
|
|---|---|---|
|
Aggregated Withdrawal Score at Week 6
|
4.8 units on a scale
Standard Deviation 5.11
|
3.8 units on a scale
Standard Deviation 3.80
|
SECONDARY outcome
Timeframe: Week 1Population: Analysis was based on randomized participants who reported use data for at least 4 of the days in that week.
Total Daily Number of Self-Reported Spray Doses
Outcome measures
| Measure |
Placebo
n=512 Participants
Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions
|
Nicotine
n=502 Participants
Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions
|
|---|---|---|
|
Total Daily Number of Self-Reported Spray Doses at Week 1
|
15.6 Number of sprays
Standard Deviation 10.77
|
12.3 Number of sprays
Standard Deviation 8.78
|
SECONDARY outcome
Timeframe: Week 2Population: Analysis was based on randomized participants who reported use data for at least 4 of the days in that week.
Total Daily Number of Self-Reported Spray Doses
Outcome measures
| Measure |
Placebo
n=492 Participants
Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions
|
Nicotine
n=486 Participants
Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions
|
|---|---|---|
|
Total Daily Number of Self-Reported Spray Doses at Week 2
|
15.7 Number of sprays
Standard Deviation 12.08
|
11.8 Number of sprays
Standard Deviation 9.19
|
SECONDARY outcome
Timeframe: Week 3Population: Analysis was based on randomized participants who reported use data for at least 4 of the days in that week.
Total Daily Number of Self-Reported Spray Doses
Outcome measures
| Measure |
Placebo
n=467 Participants
Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions
|
Nicotine
n=462 Participants
Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions
|
|---|---|---|
|
Total Daily Number of Self-Reported Spray Doses at Week 3
|
14.6 Number of sprays
Standard Deviation 11.15
|
11.6 Number of sprays
Standard Deviation 9.31
|
SECONDARY outcome
Timeframe: Week 4Population: Analysis was based on randomized participants who reported use data for at least 4 of the days in that week.
Total Daily Number of Self-Reported Spray Doses
Outcome measures
| Measure |
Placebo
n=449 Participants
Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions
|
Nicotine
n=444 Participants
Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions
|
|---|---|---|
|
Total Daily Number of Self-Reported Spray Doses at Week 4
|
13.8 Number of sprays
Standard Deviation 11.05
|
11.3 Number of sprays
Standard Deviation 10.66
|
SECONDARY outcome
Timeframe: Week 5Population: Analysis was based on randomized participants who reported use data for at least 4 of the days in that week.
Total Daily Number of Self-Reported Spray Doses
Outcome measures
| Measure |
Placebo
n=423 Participants
Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions
|
Nicotine
n=428 Participants
Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions
|
|---|---|---|
|
Total Daily Number of Self-Reported Spray Doses at Week 5
|
14.2 Number of sprays
Standard Deviation 12.17
|
10.9 Number of sprays
Standard Deviation 9.91
|
SECONDARY outcome
Timeframe: Week 6Population: Analysis was based on randomized participants who reported use data for at least 4 of the days in that week.
Total Daily Number of Self-Reported Spray Doses
Outcome measures
| Measure |
Placebo
n=406 Participants
Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions
|
Nicotine
n=412 Participants
Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions
|
|---|---|---|
|
Total Daily Number of Self-Reported Spray Doses at Week 6
|
13.1 Number of sprays
Standard Deviation 10.49
|
10.5 Number of sprays
Standard Deviation 9.71
|
SECONDARY outcome
Timeframe: Week 7Population: Analysis was based on randomized participants who reported use data for at least 4 of the days in that week.
Total Daily Number of Self-Reported Spray Doses
Outcome measures
| Measure |
Placebo
n=392 Participants
Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions
|
Nicotine
n=387 Participants
Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions
|
|---|---|---|
|
Total Daily Number of Self-Reported Spray Doses at Week 7
|
12.3 Number of sprays
Standard Deviation 9.63
|
9.9 Number of sprays
Standard Deviation 8.80
|
SECONDARY outcome
Timeframe: Week 8Population: Analysis was based on randomized participants who reported use data for at least 4 of the days in that week.
Total Daily Number of Self-Reported Spray Doses
Outcome measures
| Measure |
Placebo
n=378 Participants
Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions
|
Nicotine
n=377 Participants
Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions
|
|---|---|---|
|
Total Daily Number of Self-Reported Spray Doses at Week 8
|
12.1 Number of sprays
Standard Deviation 10.15
|
10.1 Number of sprays
Standard Deviation 8.90
|
SECONDARY outcome
Timeframe: Week 9Population: Analysis was based on randomized participants who reported use data for at least 4 of the days in that week.
Total Daily Number of Self-Reported Spray Doses
Outcome measures
| Measure |
Placebo
n=356 Participants
Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions
|
Nicotine
n=362 Participants
Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions
|
|---|---|---|
|
Total Daily Number of Self-Reported Spray Doses at Week 9
|
11.8 Number of sprays
Standard Deviation 9.98
|
9.7 Number of sprays
Standard Deviation 8.92
|
SECONDARY outcome
Timeframe: Week 10Population: Analysis was based on randomized participants who reported use data for at least 4 of the days in that week.
Total Daily Number of Self-Reported Spray Doses
Outcome measures
| Measure |
Placebo
n=336 Participants
Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions
|
Nicotine
n=337 Participants
Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions
|
|---|---|---|
|
Total Daily Number of Self-Reported Spray Doses at Week 10
|
11.6 Number of sprays
Standard Deviation 9.86
|
9.3 Number of sprays
Standard Deviation 8.66
|
SECONDARY outcome
Timeframe: Week 11Population: Analysis was based on randomized participants who reported use data for at least 4 of the days in that week.
Total Daily Number of Self-Reported Spray Doses
Outcome measures
| Measure |
Placebo
n=317 Participants
Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions
|
Nicotine
n=329 Participants
Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions
|
|---|---|---|
|
Total Daily Number of Self-Reported Spray Doses at Week 11
|
11.3 Number of sprays
Standard Deviation 9.80
|
8.8 Number of sprays
Standard Deviation 8.55
|
SECONDARY outcome
Timeframe: Week 12Population: Analysis was based on randomized participants who reported use data for at least 4 of the days in that week.
Total Daily Number of Self-Reported Spray Doses
Outcome measures
| Measure |
Placebo
n=306 Participants
Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions
|
Nicotine
n=332 Participants
Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions
|
|---|---|---|
|
Total Daily Number of Self-Reported Spray Doses at Week 12
|
9.7 Number of sprays
Standard Deviation 7.69
|
7.9 Number of sprays
Standard Deviation 7.90
|
SECONDARY outcome
Timeframe: Week 13Population: Analysis was based on randomized participants who reported use data for at least 4 of the days in that week.
Total Daily Number of Self-Reported Spray Doses
Outcome measures
| Measure |
Placebo
n=240 Participants
Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions
|
Nicotine
n=251 Participants
Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions
|
|---|---|---|
|
Total Daily Number of Self-Reported Spray Doses at Week 13
|
10.2 Number of sprays
Standard Deviation 8.28
|
8.4 Number of sprays
Standard Deviation 8.36
|
SECONDARY outcome
Timeframe: Week 14Population: Analysis was based on randomized participants who reported use data for at least 4 of the days in that week.
Total Daily Number of Self-Reported Spray Doses
Outcome measures
| Measure |
Placebo
n=223 Participants
Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions
|
Nicotine
n=237 Participants
Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions
|
|---|---|---|
|
Total Daily Number of Self-Reported Spray Doses at Week 14
|
10.3 Number of sprays
Standard Deviation 9.20
|
9.2 Number of sprays
Standard Deviation 12.88
|
SECONDARY outcome
Timeframe: Week 15Population: Analysis was based on randomized participants who reported use data for at least 4 of the days in that week.
Total Daily Number of Self-Reported Spray Doses
Outcome measures
| Measure |
Placebo
n=213 Participants
Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions
|
Nicotine
n=228 Participants
Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions
|
|---|---|---|
|
Total Daily Number of Self-Reported Spray Doses at Week 15
|
10.5 Number of sprays
Standard Deviation 9.66
|
8.2 Number of sprays
Standard Deviation 8.47
|
SECONDARY outcome
Timeframe: Week 16Population: Analysis was based on randomized participants who reported use data for at least 4 of the days in that week.
Total Daily Number of Self-Reported Spray Doses
Outcome measures
| Measure |
Placebo
n=206 Participants
Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions
|
Nicotine
n=218 Participants
Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions
|
|---|---|---|
|
Total Daily Number of Self-Reported Spray Doses at Week 16
|
9.2 Number of sprays
Standard Deviation 8.70
|
8.0 Number of sprays
Standard Deviation 8.47
|
SECONDARY outcome
Timeframe: Week 17Population: Analysis was based on randomized participants who reported use data for at least 4 of the days in that week.
Total Daily Number of Self-Reported Spray Doses
Outcome measures
| Measure |
Placebo
n=189 Participants
Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions
|
Nicotine
n=194 Participants
Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions
|
|---|---|---|
|
Total Daily Number of Self-Reported Spray Doses at Week 17
|
9.2 Number of sprays
Standard Deviation 8.58
|
8.0 Number of sprays
Standard Deviation 7.56
|
SECONDARY outcome
Timeframe: Week 18Population: Analysis was based on randomized participants who reported use data for at least 4 of the days in that week.
Total Daily Number of Self-Reported Spray Doses
Outcome measures
| Measure |
Placebo
n=182 Participants
Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions
|
Nicotine
n=192 Participants
Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions
|
|---|---|---|
|
Total Daily Number of Self-Reported Spray Doses at Week 18
|
9.4 Number of sprays
Standard Deviation 8.84
|
8.2 Number of sprays
Standard Deviation 8.80
|
SECONDARY outcome
Timeframe: Week 19Population: Analysis was based on randomized participants who reported use data for at least 4 of the days in that week.
Total Daily Number of Self-Reported Spray Doses
Outcome measures
| Measure |
Placebo
n=171 Participants
Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions
|
Nicotine
n=180 Participants
Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions
|
|---|---|---|
|
Total Daily Number of Self-Reported Spray Doses at Week 19
|
9.1 Number of sprays
Standard Deviation 8.49
|
8.3 Number of sprays
Standard Deviation 8.59
|
SECONDARY outcome
Timeframe: Week 20Population: Analysis was based on randomized participants who reported use data for at least 4 of the days in that week.
Total Daily Number of Self-Reported Spray Doses
Outcome measures
| Measure |
Placebo
n=173 Participants
Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions
|
Nicotine
n=174 Participants
Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions
|
|---|---|---|
|
Total Daily Number of Self-Reported Spray Doses at Week 20
|
7.8 Number of sprays
Standard Deviation 6.94
|
8.2 Number of sprays
Standard Deviation 8.50
|
SECONDARY outcome
Timeframe: Week 21Population: Analysis was based on randomized participants who reported use data for at least 4 of the days in that week.
Total Daily Number of Self-Reported Spray Doses
Outcome measures
| Measure |
Placebo
n=164 Participants
Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions
|
Nicotine
n=161 Participants
Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions
|
|---|---|---|
|
Total Daily Number of Self-Reported Spray Doses at Week 21
|
7.8 Number of sprays
Standard Deviation 7.32
|
8.2 Number of sprays
Standard Deviation 8.84
|
SECONDARY outcome
Timeframe: Week 22Population: Analysis was based on randomized participants who reported use data for at least 4 of the days in that week.
Total Daily Number of Self-Reported Spray Doses
Outcome measures
| Measure |
Placebo
n=155 Participants
Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions
|
Nicotine
n=158 Participants
Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions
|
|---|---|---|
|
Total Daily Number of Self-Reported Spray Doses at Week 22
|
7.5 Number of sprays
Standard Deviation 7.27
|
7.8 Number of sprays
Standard Deviation 8.32
|
SECONDARY outcome
Timeframe: Week 23Population: Analysis was based on randomized participants who reported use data for at least 4 of the days in that week.
Total Daily Number of Self-Reported Spray Doses
Outcome measures
| Measure |
Placebo
n=147 Participants
Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions
|
Nicotine
n=155 Participants
Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions
|
|---|---|---|
|
Total Daily Number of Self-Reported Spray Doses at Week 23
|
7.7 Number of sprays
Standard Deviation 6.97
|
7.4 Number of sprays
Standard Deviation 8.04
|
SECONDARY outcome
Timeframe: Week 24Population: Analysis was based on randomized participants who reported use data for at least 4 of the days in that week.
Total Daily Number of Self-Reported Spray Doses
Outcome measures
| Measure |
Placebo
n=139 Participants
Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions
|
Nicotine
n=143 Participants
Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions
|
|---|---|---|
|
Total Daily Number of Self-Reported Spray Doses at Week 24
|
7.2 Number of sprays
Standard Deviation 6.50
|
7.2 Number of sprays
Standard Deviation 8.09
|
SECONDARY outcome
Timeframe: Week 25Population: Analysis was based on randomized participants who reported use data for at least 4 of the days in that week.
Total Daily Number of Self-Reported Spray Doses
Outcome measures
| Measure |
Placebo
n=142 Participants
Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions
|
Nicotine
n=143 Participants
Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions
|
|---|---|---|
|
Total Daily Number of Self-Reported Spray Doses at Week 25
|
6.6 Number of sprays
Standard Deviation 6.08
|
6.7 Number of sprays
Standard Deviation 7.95
|
SECONDARY outcome
Timeframe: Week 26Population: Analysis was based on randomized participants who reported use data for at least 4 of the days in that week.
Total Daily Number of Self-Reported Spray Doses
Outcome measures
| Measure |
Placebo
n=129 Participants
Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions
|
Nicotine
n=137 Participants
Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions
|
|---|---|---|
|
Total Daily Number of Self-Reported Spray Doses at Week 26
|
6.3 Number of sprays
Standard Deviation 5.91
|
6.3 Number of sprays
Standard Deviation 6.81
|
SECONDARY outcome
Timeframe: Week 1Population: Analysis was based on randomized participants who reported use data for at least 4 of the days in that week.
Maximum Total Daily Number of Self-Reported Spray Doses
Outcome measures
| Measure |
Placebo
n=512 Participants
Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions
|
Nicotine
n=502 Participants
Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions
|
|---|---|---|
|
Maximum Total Daily Number of Self-Reported Spray Doses at Week 1
|
22.1 Number of sprays
Standard Deviation 17.66
|
17.2 Number of sprays
Standard Deviation 11.63
|
SECONDARY outcome
Timeframe: Week 2Population: Analysis was based on randomized participants who reported use data for at least 4 of the days in that week.
Maximum Total Daily Number of Self-Reported Spray Doses
Outcome measures
| Measure |
Placebo
n=492 Participants
Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions
|
Nicotine
n=486 Participants
Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions
|
|---|---|---|
|
Maximum Total Daily Number of Self-Reported Spray Doses at Week 2
|
21.2 Number of sprays
Standard Deviation 16.83
|
15.4 Number of sprays
Standard Deviation 10.96
|
SECONDARY outcome
Timeframe: Week 3Population: Analysis was based on randomized participants who reported use data for at least 4 of the days in that week.
Maximum Total Daily Number of Self-Reported Spray Doses
Outcome measures
| Measure |
Placebo
n=467 Participants
Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions
|
Nicotine
n=462 Participants
Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions
|
|---|---|---|
|
Maximum Total Daily Number of Self-Reported Spray Doses at Week 3
|
19.2 Number of sprays
Standard Deviation 14.78
|
15.2 Number of sprays
Standard Deviation 13.51
|
SECONDARY outcome
Timeframe: Week 4Population: Analysis was based on randomized participants who reported use data for at least 4 of the days in that week.
Maximum Total Daily Number of Self-Reported Spray Doses
Outcome measures
| Measure |
Placebo
n=449 Participants
Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions
|
Nicotine
n=444 Participants
Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions
|
|---|---|---|
|
Maximum Total Daily Number of Self-Reported Spray Doses at Week 4
|
17.9 Number of sprays
Standard Deviation 13.58
|
15.8 Number of sprays
Standard Deviation 23.44
|
SECONDARY outcome
Timeframe: Week 5Population: Analysis was based on randomized participants who reported use data for at least 4 of the days in that week.
Maximum Total Daily Number of Self-Reported Spray Doses
Outcome measures
| Measure |
Placebo
n=423 Participants
Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions
|
Nicotine
n=428 Participants
Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions
|
|---|---|---|
|
Maximum Total Daily Number of Self-Reported Spray Doses at Week 5
|
19.2 Number of sprays
Standard Deviation 30.71
|
15.1 Number of sprays
Standard Deviation 27.65
|
SECONDARY outcome
Timeframe: Week 6Population: Analysis was based on randomized participants who reported use data for at least 4 of the days in that week.
Maximum Total Daily Number of Self-Reported Spray Doses
Outcome measures
| Measure |
Placebo
n=406 Participants
Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions
|
Nicotine
n=412 Participants
Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions
|
|---|---|---|
|
Maximum Total Daily Number of Self-Reported Spray Doses at Week 6
|
17.5 Number of sprays
Standard Deviation 14.59
|
14.6 Number of sprays
Standard Deviation 24.02
|
SECONDARY outcome
Timeframe: Week 7Population: Analysis was based on randomized participants who reported use data for at least 4 of the days in that week.
Maximum Total Daily Number of Self-Reported Spray Doses
Outcome measures
| Measure |
Placebo
n=392 Participants
Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions
|
Nicotine
n=387 Participants
Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions
|
|---|---|---|
|
Maximum Total Daily Number of Self-Reported Spray Doses at Week 7
|
16.0 Number of sprays
Standard Deviation 12.39
|
12.8 Number of sprays
Standard Deviation 11.57
|
SECONDARY outcome
Timeframe: Week 8Population: Analysis was based on randomized participants who reported use data for at least 4 of the days in that week.
Maximum Total Daily Number of Self-Reported Spray Doses
Outcome measures
| Measure |
Placebo
n=378 Participants
Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions
|
Nicotine
n=377 Participants
Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions
|
|---|---|---|
|
Maximum Total Daily Number of Self-Reported Spray Doses at Week 8
|
16.0 Number of sprays
Standard Deviation 13.05
|
13.6 Number of sprays
Standard Deviation 14.59
|
SECONDARY outcome
Timeframe: Week 9Population: Analysis was based on randomized participants who reported use data for at least 4 of the days in that week.
Maximum Total Daily Number of Self-Reported Spray Doses
Outcome measures
| Measure |
Placebo
n=356 Participants
Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions
|
Nicotine
n=362 Participants
Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions
|
|---|---|---|
|
Maximum Total Daily Number of Self-Reported Spray Doses at Week 9
|
15.4 Number of sprays
Standard Deviation 13.53
|
12.2 Number of sprays
Standard Deviation 11.01
|
SECONDARY outcome
Timeframe: Week 10Population: Analysis was based on randomized participants who reported use data for at least 4 of the days in that week.
Maximum Total Daily Number of Self-Reported Spray Doses
Outcome measures
| Measure |
Placebo
n=336 Participants
Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions
|
Nicotine
n=337 Participants
Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions
|
|---|---|---|
|
Maximum Total Daily Number of Self-Reported Spray Doses at Week 10
|
14.7 Number of sprays
Standard Deviation 12.47
|
11.4 Number of sprays
Standard Deviation 10.08
|
SECONDARY outcome
Timeframe: Week 11Population: Analysis was based on randomized participants who reported use data for at least 4 of the days in that week.
Maximum Total Daily Number of Self-Reported Spray Doses
Outcome measures
| Measure |
Placebo
n=317 Participants
Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions
|
Nicotine
n=329 Participants
Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions
|
|---|---|---|
|
Maximum Total Daily Number of Self-Reported Spray Doses at Week 11
|
15.1 Number of sprays
Standard Deviation 26.23
|
11.2 Number of sprays
Standard Deviation 11.35
|
SECONDARY outcome
Timeframe: Week 12Population: Analysis was based on randomized participants who reported use data for at least 4 of the days in that week.
Maximum Total Daily Number of Self-Reported Spray Doses
Outcome measures
| Measure |
Placebo
n=306 Participants
Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions
|
Nicotine
n=332 Participants
Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions
|
|---|---|---|
|
Maximum Total Daily Number of Self-Reported Spray Doses at Week 12
|
12.6 Number of sprays
Standard Deviation 9.70
|
9.8 Number of sprays
Standard Deviation 8.82
|
SECONDARY outcome
Timeframe: Week 13Population: Analysis was based on randomized participants who reported use data for at least 4 of the days in that week.
Maximum Total Daily Number of Self-Reported Spray Doses
Outcome measures
| Measure |
Placebo
n=240 Participants
Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions
|
Nicotine
n=251 Participants
Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions
|
|---|---|---|
|
Maximum Total Daily Number of Self-Reported Spray Doses at Week 13
|
12.9 Number of sprays
Standard Deviation 9.78
|
10.5 Number of sprays
Standard Deviation 9.29
|
SECONDARY outcome
Timeframe: Week 14Population: Analysis was based on randomized participants who reported use data for at least 4 of the days in that week.
Maximum Total Daily Number of Self-Reported Spray Doses
Outcome measures
| Measure |
Placebo
n=223 Participants
Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions
|
Nicotine
n=237 Participants
Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions
|
|---|---|---|
|
Maximum Total Daily Number of Self-Reported Spray Doses at Week 14
|
13.1 Number of sprays
Standard Deviation 10.95
|
13.6 Number of sprays
Standard Deviation 40.98
|
SECONDARY outcome
Timeframe: Week 15Population: Analysis was based on randomized participants who reported use data for at least 4 of the days in that week.
Maximum Total Daily Number of Self-Reported Spray Doses
Outcome measures
| Measure |
Placebo
n=213 Participants
Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions
|
Nicotine
n=228 Participants
Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions
|
|---|---|---|
|
Maximum Total Daily Number of Self-Reported Spray Doses at Week 15
|
15.3 Number of sprays
Standard Deviation 30.31
|
10.8 Number of sprays
Standard Deviation 12.53
|
SECONDARY outcome
Timeframe: Week 16Population: Analysis was based on randomized participants who reported use data for at least 4 of the days in that week.
Maximum Total Daily Number of Self-Reported Spray Doses
Outcome measures
| Measure |
Placebo
n=206 Participants
Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions
|
Nicotine
n=218 Participants
Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions
|
|---|---|---|
|
Maximum Total Daily Number of Self-Reported Spray Doses at Week 16
|
12.4 Number of sprays
Standard Deviation 12.80
|
10.0 Number of sprays
Standard Deviation 9.87
|
SECONDARY outcome
Timeframe: Week 17Population: Analysis was based on randomized participants who reported use data for at least 4 of the days in that week.
Maximum Total Daily Number of Self-Reported Spray Doses
Outcome measures
| Measure |
Placebo
n=189 Participants
Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions
|
Nicotine
n=194 Participants
Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions
|
|---|---|---|
|
Maximum Total Daily Number of Self-Reported Spray Doses at Week 17
|
11.5 Number of sprays
Standard Deviation 10.19
|
10.5 Number of sprays
Standard Deviation 9.76
|
SECONDARY outcome
Timeframe: Week 18Population: Analysis was based on randomized participants who reported use data for at least 4 of the days in that week.
Maximum Total Daily Number of Self-Reported Spray Doses
Outcome measures
| Measure |
Placebo
n=182 Participants
Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions
|
Nicotine
n=192 Participants
Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions
|
|---|---|---|
|
Maximum Total Daily Number of Self-Reported Spray Doses at Week 18
|
12.3 Number of sprays
Standard Deviation 11.94
|
10.3 Number of sprays
Standard Deviation 10.01
|
SECONDARY outcome
Timeframe: Week 19Population: Analysis was based on randomized participants who reported use data for at least 4 of the days in that week.
Maximum Total Daily Number of Self-Reported Spray Doses
Outcome measures
| Measure |
Placebo
n=171 Participants
Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions
|
Nicotine
n=180 Participants
Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions
|
|---|---|---|
|
Maximum Total Daily Number of Self-Reported Spray Doses at Week 19
|
11.2 Number of sprays
Standard Deviation 9.85
|
10.3 Number of sprays
Standard Deviation 10.20
|
SECONDARY outcome
Timeframe: Week 20Population: Analysis was based on randomized participants who reported use data for at least 4 of the days in that week.
Maximum Total Daily Number of Self-Reported Spray Doses
Outcome measures
| Measure |
Placebo
n=173 Participants
Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions
|
Nicotine
n=174 Participants
Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions
|
|---|---|---|
|
Maximum Total Daily Number of Self-Reported Spray Doses at Week 20
|
10.5 Number of sprays
Standard Deviation 9.38
|
10.5 Number of sprays
Standard Deviation 11.69
|
SECONDARY outcome
Timeframe: Week 21Population: Analysis was based on randomized participants who reported use data for at least 4 of the days in that week.
Maximum Total Daily Number of Self-Reported Spray Doses
Outcome measures
| Measure |
Placebo
n=164 Participants
Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions
|
Nicotine
n=161 Participants
Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions
|
|---|---|---|
|
Maximum Total Daily Number of Self-Reported Spray Doses at Week 21
|
10.0 Number of sprays
Standard Deviation 8.82
|
11.0 Number of sprays
Standard Deviation 13.56
|
SECONDARY outcome
Timeframe: Week 22Population: Analysis was based on randomized participants who reported use data for at least 4 of the days in that week.
Maximum Total Daily Number of Self-Reported Spray Doses
Outcome measures
| Measure |
Placebo
n=155 Participants
Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions
|
Nicotine
n=158 Participants
Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions
|
|---|---|---|
|
Maximum Total Daily Number of Self-Reported Spray Doses at Week 22
|
9.4 Number of sprays
Standard Deviation 8.89
|
10.8 Number of sprays
Standard Deviation 16.62
|
SECONDARY outcome
Timeframe: Week 23Population: Analysis was based on randomized participants who reported use data for at least 4 of the days in that week.
Maximum Total Daily Number of Self-Reported Spray Doses
Outcome measures
| Measure |
Placebo
n=147 Participants
Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions
|
Nicotine
n=155 Participants
Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions
|
|---|---|---|
|
Maximum Total Daily Number of Self-Reported Spray Doses at Week 23
|
10.5 Number of sprays
Standard Deviation 12.79
|
9.1 Number of sprays
Standard Deviation 9.33
|
SECONDARY outcome
Timeframe: Week 24Population: Analysis was based on randomized participants who reported use data for at least 4 of the days in that week.
Maximum Total Daily Number of Self-Reported Spray Doses
Outcome measures
| Measure |
Placebo
n=139 Participants
Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions
|
Nicotine
n=143 Participants
Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions
|
|---|---|---|
|
Maximum Total Daily Number of Self-Reported Spray Doses at Week 24
|
9.2 Number of sprays
Standard Deviation 8.50
|
8.8 Number of sprays
Standard Deviation 9.20
|
SECONDARY outcome
Timeframe: Week 25Population: Analysis was based on randomized participants who reported use data for at least 4 of the days in that week.
Maximum Total Daily Number of Self-Reported Spray Doses
Outcome measures
| Measure |
Placebo
n=142 Participants
Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions
|
Nicotine
n=143 Participants
Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions
|
|---|---|---|
|
Maximum Total Daily Number of Self-Reported Spray Doses at Week 25
|
8.5 Number of sprays
Standard Deviation 7.24
|
8.4 Number of sprays
Standard Deviation 9.95
|
SECONDARY outcome
Timeframe: Week 26Population: Analysis was based on randomized participants who reported use data for at least 4 of the days in that week.
Maximum Total Daily Number of Self-Reported Spray Doses
Outcome measures
| Measure |
Placebo
n=129 Participants
Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions
|
Nicotine
n=137 Participants
Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions
|
|---|---|---|
|
Maximum Total Daily Number of Self-Reported Spray Doses at Week 26
|
8.1 Number of sprays
Standard Deviation 7.30
|
7.9 Number of sprays
Standard Deviation 7.81
|
SECONDARY outcome
Timeframe: Week 1Population: Analysis was based on randomized participants who reported use data for at least 4 of the days in that week.
Maximum Hourly Number of Self-Reported Spray Doses
Outcome measures
| Measure |
Placebo
n=512 Participants
Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions
|
Nicotine
n=502 Participants
Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions
|
|---|---|---|
|
Maximum Hourly Number of Self-Reported Spray Doses at Week 1
|
6.0 Number of sprays
Standard Deviation 7.11
|
4.8 Number of sprays
Standard Deviation 4.93
|
SECONDARY outcome
Timeframe: Week 2Population: Analysis was based on randomized participants who reported use data for at least 4 of the days in that week.
Maximum Hourly Number of Self-Reported Spray Doses
Outcome measures
| Measure |
Placebo
n=492 Participants
Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions
|
Nicotine
n=486 Participants
Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions
|
|---|---|---|
|
Maximum Hourly Number of Self-Reported Spray Doses at Week 2
|
4.8 Number of sprays
Standard Deviation 6.13
|
3.4 Number of sprays
Standard Deviation 3.42
|
SECONDARY outcome
Timeframe: Week 3Population: Analysis was based on randomized participants who reported use data for at least 4 of the days in that week.
Maximum Hourly Number of Self-Reported Spray Doses
Outcome measures
| Measure |
Placebo
n=467 Participants
Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions
|
Nicotine
n=462 Participants
Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions
|
|---|---|---|
|
Maximum Hourly Number of Self-Reported Spray Doses at Week 3
|
4.3 Number of sprays
Standard Deviation 4.93
|
3.1 Number of sprays
Standard Deviation 2.87
|
SECONDARY outcome
Timeframe: Week 4Population: Analysis was based on randomized participants who reported use data for at least 4 of the days in that week.
Maximum Hourly Number of Self-Reported Spray Doses
Outcome measures
| Measure |
Placebo
n=449 Participants
Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions
|
Nicotine
n=444 Participants
Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions
|
|---|---|---|
|
Maximum Hourly Number of Self-Reported Spray Doses at Week 4
|
4.1 Number of sprays
Standard Deviation 4.49
|
3.0 Number of sprays
Standard Deviation 3.05
|
SECONDARY outcome
Timeframe: Week 5Population: Analysis was based on randomized participants who reported use data for at least 4 of the days in that week.
Maximum Hourly Number of Self-Reported Spray Doses
Outcome measures
| Measure |
Placebo
n=423 Participants
Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions
|
Nicotine
n=428 Participants
Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions
|
|---|---|---|
|
Maximum Hourly Number of Self-Reported Spray Doses at Week 5
|
3.7 Number of sprays
Standard Deviation 3.73
|
2.8 Number of sprays
Standard Deviation 3.25
|
SECONDARY outcome
Timeframe: Week 6Population: Analysis was based on randomized participants who reported use data for at least 4 of the days in that week.
Maximum Hourly Number of Self-Reported Spray Doses
Outcome measures
| Measure |
Placebo
n=406 Participants
Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions
|
Nicotine
n=412 Participants
Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions
|
|---|---|---|
|
Maximum Hourly Number of Self-Reported Spray Doses at Week 6
|
3.7 Number of sprays
Standard Deviation 4.23
|
2.7 Number of sprays
Standard Deviation 2.33
|
SECONDARY outcome
Timeframe: Week 7Population: Analysis was based on randomized participants who reported use data for at least 4 of the days in that week.
Maximum Hourly Number of Self-Reported Spray Doses
Outcome measures
| Measure |
Placebo
n=392 Participants
Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions
|
Nicotine
n=387 Participants
Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions
|
|---|---|---|
|
Maximum Hourly Number of Self-Reported Spray Doses at Week 7
|
3.6 Number of sprays
Standard Deviation 4.88
|
2.9 Number of sprays
Standard Deviation 4.14
|
SECONDARY outcome
Timeframe: Week 8Population: Analysis was based on randomized participants who reported use data for at least 4 of the days in that week.
Maximum Hourly Number of Self-Reported Spray Doses
Outcome measures
| Measure |
Placebo
n=378 Participants
Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions
|
Nicotine
n=377 Participants
Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions
|
|---|---|---|
|
Maximum Hourly Number of Self-Reported Spray Doses at Week 8
|
3.3 Number of sprays
Standard Deviation 3.31
|
2.6 Number of sprays
Standard Deviation 2.67
|
SECONDARY outcome
Timeframe: Week 9Population: Analysis was based on randomized participants who reported use data for at least 4 of the days in that week.
Maximum Hourly Number of Self-Reported Spray Doses
Outcome measures
| Measure |
Placebo
n=356 Participants
Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions
|
Nicotine
n=362 Participants
Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions
|
|---|---|---|
|
Maximum Hourly Number of Self-Reported Spray Doses at Week 9
|
3.3 Number of sprays
Standard Deviation 3.52
|
2.3 Number of sprays
Standard Deviation 2.13
|
SECONDARY outcome
Timeframe: Week 10Population: Analysis was based on randomized participants who reported use data for at least 4 of the days in that week.
Maximum Hourly Number of Self-Reported Spray Doses
Outcome measures
| Measure |
Placebo
n=336 Participants
Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions
|
Nicotine
n=337 Participants
Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions
|
|---|---|---|
|
Maximum Hourly Number of Self-Reported Spray Doses at Week 10
|
3.2 Number of sprays
Standard Deviation 3.28
|
2.3 Number of sprays
Standard Deviation 2.19
|
SECONDARY outcome
Timeframe: Week 11Population: Analysis was based on randomized participants who reported use data for at least 4 of the days in that week.
Maximum Hourly Number of Self-Reported Spray Doses
Outcome measures
| Measure |
Placebo
n=317 Participants
Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions
|
Nicotine
n=329 Participants
Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions
|
|---|---|---|
|
Maximum Hourly Number of Self-Reported Spray Doses at Week 11
|
3.0 Number of sprays
Standard Deviation 2.65
|
2.2 Number of sprays
Standard Deviation 2.00
|
SECONDARY outcome
Timeframe: Week 12Population: Analysis was based on randomized participants who reported use data for at least 4 of the days in that week.
Maximum Hourly Number of Self-Reported Spray Doses
Outcome measures
| Measure |
Placebo
n=306 Participants
Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions
|
Nicotine
n=332 Participants
Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions
|
|---|---|---|
|
Maximum Hourly Number of Self-Reported Spray Doses at Week 12
|
2.8 Number of sprays
Standard Deviation 2.84
|
2.0 Number of sprays
Standard Deviation 1.78
|
SECONDARY outcome
Timeframe: Week 13Population: Analysis was based on randomized participants who reported use data for at least 4 of the days in that week.
Maximum Hourly Number of Self-Reported Spray Doses
Outcome measures
| Measure |
Placebo
n=240 Participants
Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions
|
Nicotine
n=251 Participants
Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions
|
|---|---|---|
|
Maximum Hourly Number of Self-Reported Spray Doses at Week 13
|
2.7 Number of sprays
Standard Deviation 2.65
|
2.2 Number of sprays
Standard Deviation 1.72
|
SECONDARY outcome
Timeframe: Week 14Population: Analysis was based on randomized participants who reported use data for at least 4 of the days in that week.
Maximum Hourly Number of Self-Reported Spray Doses
Outcome measures
| Measure |
Placebo
n=223 Participants
Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions
|
Nicotine
n=237 Participants
Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions
|
|---|---|---|
|
Maximum Hourly Number of Self-Reported Spray Doses at Week 14
|
2.9 Number of sprays
Standard Deviation 2.69
|
2.2 Number of sprays
Standard Deviation 2.28
|
SECONDARY outcome
Timeframe: Week 15Population: Analysis was based on randomized participants who reported use data for at least 4 of the days in that week.
Maximum Hourly Number of Self-Reported Spray Doses
Outcome measures
| Measure |
Placebo
n=213 Participants
Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions
|
Nicotine
n=228 Participants
Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions
|
|---|---|---|
|
Maximum Hourly Number of Self-Reported Spray Doses at Week 15
|
2.6 Number of sprays
Standard Deviation 2.30
|
2.4 Number of sprays
Standard Deviation 3.38
|
SECONDARY outcome
Timeframe: Week 16Population: Analysis was based on randomized participants who reported use data for at least 4 of the days in that week.
Maximum Hourly Number of Self-Reported Spray Doses
Outcome measures
| Measure |
Placebo
n=206 Participants
Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions
|
Nicotine
n=218 Participants
Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions
|
|---|---|---|
|
Maximum Hourly Number of Self-Reported Spray Doses at Week 16
|
2.7 Number of sprays
Standard Deviation 3.24
|
2.1 Number of sprays
Standard Deviation 2.30
|
SECONDARY outcome
Timeframe: Week 17Population: Analysis was based on randomized participants who reported use data for at least 4 of the days in that week.
Maximum Hourly Number of Self-Reported Spray Doses
Outcome measures
| Measure |
Placebo
n=189 Participants
Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions
|
Nicotine
n=194 Participants
Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions
|
|---|---|---|
|
Maximum Hourly Number of Self-Reported Spray Doses at Week 17
|
2.5 Number of sprays
Standard Deviation 2.75
|
2.1 Number of sprays
Standard Deviation 1.72
|
SECONDARY outcome
Timeframe: Week 18Population: Analysis was based on randomized participants who reported use data for at least 4 of the days in that week.
Maximum Hourly Number of Self-Reported Spray Doses
Outcome measures
| Measure |
Placebo
n=182 Participants
Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions
|
Nicotine
n=192 Participants
Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions
|
|---|---|---|
|
Maximum Hourly Number of Self-Reported Spray Doses at Week 18
|
2.4 Number of sprays
Standard Deviation 2.22
|
2.3 Number of sprays
Standard Deviation 2.68
|
SECONDARY outcome
Timeframe: Week 19Population: Analysis was based on randomized participants who reported use data for at least 4 of the days in that week.
Maximum Hourly Number of Self-Reported Spray Doses
Outcome measures
| Measure |
Placebo
n=171 Participants
Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions
|
Nicotine
n=180 Participants
Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions
|
|---|---|---|
|
Maximum Hourly Number of Self-Reported Spray Doses at Week 19
|
2.6 Number of sprays
Standard Deviation 3.02
|
2.3 Number of sprays
Standard Deviation 2.34
|
SECONDARY outcome
Timeframe: Week 20Population: Analysis was based on randomized participants who reported use data for at least 4 of the days in that week.
Maximum Hourly Number of Self-Reported Spray Doses
Outcome measures
| Measure |
Placebo
n=173 Participants
Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions
|
Nicotine
n=174 Participants
Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions
|
|---|---|---|
|
Maximum Hourly Number of Self-Reported Spray Doses at Week 20
|
2.4 Number of sprays
Standard Deviation 2.56
|
2.0 Number of sprays
Standard Deviation 1.99
|
SECONDARY outcome
Timeframe: Week 21Population: Analysis was based on randomized participants who reported use data for at least 4 of the days in that week.
Maximum Hourly Number of Self-Reported Spray Doses
Outcome measures
| Measure |
Placebo
n=164 Participants
Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions
|
Nicotine
n=161 Participants
Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions
|
|---|---|---|
|
Maximum Hourly Number of Self-Reported Spray Doses at Week 21
|
2.3 Number of sprays
Standard Deviation 2.52
|
2.1 Number of sprays
Standard Deviation 2.10
|
SECONDARY outcome
Timeframe: Week 22Population: Analysis was based on randomized participants who reported use data for at least 4 of the days in that week.
Maximum Hourly Number of Self-Reported Spray Doses
Outcome measures
| Measure |
Placebo
n=155 Participants
Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions
|
Nicotine
n=158 Participants
Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions
|
|---|---|---|
|
Maximum Hourly Number of Self-Reported Spray Doses at Week 22
|
2.3 Number of sprays
Standard Deviation 2.86
|
2.0 Number of sprays
Standard Deviation 2.03
|
SECONDARY outcome
Timeframe: Week 23Population: Analysis was based on randomized participants who reported use data for at least 4 of the days in that week.
Maximum Hourly Number of Self-Reported Spray Doses
Outcome measures
| Measure |
Placebo
n=147 Participants
Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions
|
Nicotine
n=155 Participants
Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions
|
|---|---|---|
|
Maximum Hourly Number of Self-Reported Spray Doses at Week 23
|
2.1 Number of sprays
Standard Deviation 1.92
|
2.0 Number of sprays
Standard Deviation 2.23
|
SECONDARY outcome
Timeframe: Week 24Population: Analysis was based on randomized participants who reported use data for at least 4 of the days in that week.
Maximum Hourly Number of Self-Reported Spray Doses
Outcome measures
| Measure |
Placebo
n=139 Participants
Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions
|
Nicotine
n=143 Participants
Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions
|
|---|---|---|
|
Maximum Hourly Number of Self-Reported Spray Doses at Week 24
|
2.4 Number of sprays
Standard Deviation 4.23
|
1.9 Number of sprays
Standard Deviation 2.42
|
SECONDARY outcome
Timeframe: Week 25Population: Analysis was based on randomized participants who reported use data for at least 4 of the days in that week.
Maximum Hourly Number of Self-Reported Spray Doses
Outcome measures
| Measure |
Placebo
n=142 Participants
Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions
|
Nicotine
n=143 Participants
Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions
|
|---|---|---|
|
Maximum Hourly Number of Self-Reported Spray Doses at Week 25
|
2.0 Number of sprays
Standard Deviation 2.33
|
1.8 Number of sprays
Standard Deviation 2.09
|
SECONDARY outcome
Timeframe: Week 26Population: Analysis was based on randomized participants who reported use data for at least 4 of the days in that week.
Maximum Hourly Number of Self-Reported Spray Doses
Outcome measures
| Measure |
Placebo
n=129 Participants
Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions
|
Nicotine
n=137 Participants
Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions
|
|---|---|---|
|
Maximum Hourly Number of Self-Reported Spray Doses at Week 26
|
2.1 Number of sprays
Standard Deviation 2.59
|
1.8 Number of sprays
Standard Deviation 2.16
|
SECONDARY outcome
Timeframe: Week 1Population: Analysis was based on randomized participants who reported non-abstinence from smoking since last visit.
Number of Cigarettes Smoked Since Last Visit
Outcome measures
| Measure |
Placebo
n=523 Participants
Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions
|
Nicotine
n=496 Participants
Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions
|
|---|---|---|
|
Number of Cigarettes Smoked Since Last Visit at Week 1
|
36.2 Number of cigarettes
Standard Deviation 37.89
|
34.0 Number of cigarettes
Standard Deviation 40.57
|
SECONDARY outcome
Timeframe: Week 2Population: Analysis was based on randomized participants who reported non-abstinence from smoking since last visit.
Number of Cigarettes Smoked Since Last Visit
Outcome measures
| Measure |
Placebo
n=507 Participants
Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions
|
Nicotine
n=472 Participants
Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions
|
|---|---|---|
|
Number of Cigarettes Smoked Since Last Visit at Week 2
|
38.9 Number of cigarettes
Standard Deviation 44.21
|
35.8 Number of cigarettes
Standard Deviation 48.20
|
SECONDARY outcome
Timeframe: Week 4Population: Analysis was based on randomized participants who reported non-abstinence from smoking during the preceding week.
Number of Cigarettes Smoked Per Day
Outcome measures
| Measure |
Placebo
n=451 Participants
Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions
|
Nicotine
n=430 Participants
Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions
|
|---|---|---|
|
Number of Cigarettes Smoked Per Day at Week 4
|
7.3 Number of cigarettes
Standard Deviation 7.77
|
6.6 Number of cigarettes
Standard Deviation 8.01
|
SECONDARY outcome
Timeframe: Week 6Population: Analysis was based on randomized participants who reported non-abstinence from smoking during the preceding week.
Number of Cigarettes Smoked Per Day
Outcome measures
| Measure |
Placebo
n=412 Participants
Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions
|
Nicotine
n=393 Participants
Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions
|
|---|---|---|
|
Number of Cigarettes Smoked Per Day at Week 6
|
7.0 Number of cigarettes
Standard Deviation 7.63
|
6.6 Number of cigarettes
Standard Deviation 6.25
|
SECONDARY outcome
Timeframe: Week 8Population: Analysis was based on randomized participants who reported non-abstinence from smoking during the preceding week.
Number of Cigarettes Smoked Per Day
Outcome measures
| Measure |
Placebo
n=396 Participants
Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions
|
Nicotine
n=374 Participants
Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions
|
|---|---|---|
|
Number of Cigarettes Smoked Per Day at Week 8
|
6.8 Number of cigarettes
Standard Deviation 5.82
|
6.3 Number of cigarettes
Standard Deviation 5.93
|
SECONDARY outcome
Timeframe: Week 12Population: Analysis was based on randomized participants who reported non-abstinence from smoking during the preceding week.
Number of Cigarettes Smoked Per Day
Outcome measures
| Measure |
Placebo
n=362 Participants
Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions
|
Nicotine
n=339 Participants
Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions
|
|---|---|---|
|
Number of Cigarettes Smoked Per Day at Week 12
|
7.1 Number of cigarettes
Standard Deviation 5.94
|
7.5 Number of cigarettes
Standard Deviation 8.25
|
SECONDARY outcome
Timeframe: Week 16Population: Analysis was based on randomized participants who reported non-abstinence from smoking during the preceding week.
Number of Cigarettes Smoked Per Day
Outcome measures
| Measure |
Placebo
n=316 Participants
Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions
|
Nicotine
n=315 Participants
Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions
|
|---|---|---|
|
Number of Cigarettes Smoked Per Day at Week 16
|
7.7 Number of cigarettes
Standard Deviation 7.71
|
7.3 Number of cigarettes
Standard Deviation 6.60
|
SECONDARY outcome
Timeframe: Week 20Population: Analysis was based on randomized participants who reported non-abstinence from smoking during the preceding week.
Number of Cigarettes Smoked Per Day
Outcome measures
| Measure |
Placebo
n=293 Participants
Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions
|
Nicotine
n=293 Participants
Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions
|
|---|---|---|
|
Number of Cigarettes Smoked Per Day at Week 20
|
7.0 Number of cigarettes
Standard Deviation 7.50
|
7.2 Number of cigarettes
Standard Deviation 5.90
|
SECONDARY outcome
Timeframe: Week 26Population: Analysis was based on randomized participants who reported non-abstinence from smoking during the preceding week.
Number of Cigarettes Smoked Per Day
Outcome measures
| Measure |
Placebo
n=298 Participants
Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions
|
Nicotine
n=279 Participants
Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions
|
|---|---|---|
|
Number of Cigarettes Smoked Per Day at Week 26
|
7.2 Number of cigarettes
Standard Deviation 6.06
|
7.5 Number of cigarettes
Standard Deviation 6.71
|
SECONDARY outcome
Timeframe: Week 1Population: Analysis was based on the Full Analysis Set which included all randomized participants.
Participants were asked to rate the investigational product on a 10-point scale of 1 - 10 (where 1=very poor and 10=excellent).
Outcome measures
| Measure |
Placebo
n=554 Participants
Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions
|
Nicotine
n=543 Participants
Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions
|
|---|---|---|
|
Percentage Distribution of the Participant Score for Overall Product Rating at Week 1
1 (Very Poor)
|
3.2 Percentage of Participants
|
1.8 Percentage of Participants
|
|
Percentage Distribution of the Participant Score for Overall Product Rating at Week 1
2
|
3.1 Percentage of Participants
|
2.6 Percentage of Participants
|
|
Percentage Distribution of the Participant Score for Overall Product Rating at Week 1
3
|
2.7 Percentage of Participants
|
3.9 Percentage of Participants
|
|
Percentage Distribution of the Participant Score for Overall Product Rating at Week 1
4
|
6.0 Percentage of Participants
|
5.2 Percentage of Participants
|
|
Percentage Distribution of the Participant Score for Overall Product Rating at Week 1
5
|
18.6 Percentage of Participants
|
16.0 Percentage of Participants
|
|
Percentage Distribution of the Participant Score for Overall Product Rating at Week 1
6
|
9.2 Percentage of Participants
|
8.5 Percentage of Participants
|
|
Percentage Distribution of the Participant Score for Overall Product Rating at Week 1
7
|
18.6 Percentage of Participants
|
18.8 Percentage of Participants
|
|
Percentage Distribution of the Participant Score for Overall Product Rating at Week 1
8
|
20.0 Percentage of Participants
|
21.2 Percentage of Participants
|
|
Percentage Distribution of the Participant Score for Overall Product Rating at Week 1
9
|
6.7 Percentage of Participants
|
7.9 Percentage of Participants
|
|
Percentage Distribution of the Participant Score for Overall Product Rating at Week 1
10 (Excellent)
|
11.9 Percentage of Participants
|
14.2 Percentage of Participants
|
SECONDARY outcome
Timeframe: Week 6Population: Analysis was based on the Full Analysis Set which included all randomized participants.
Participants were asked to rate the investigational product on a 10-point scale of 1 - 10 (where 1=very poor and 10=excellent).
Outcome measures
| Measure |
Placebo
n=470 Participants
Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions
|
Nicotine
n=467 Participants
Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions
|
|---|---|---|
|
Percentage Distribution of the Participant Score for Overall Product Rating at Week 6
4
|
5.1 Percentage of Participants
|
3.2 Percentage of Participants
|
|
Percentage Distribution of the Participant Score for Overall Product Rating at Week 6
5
|
14.9 Percentage of Participants
|
12.6 Percentage of Participants
|
|
Percentage Distribution of the Participant Score for Overall Product Rating at Week 6
1 (Very Poor)
|
5.3 Percentage of Participants
|
2.4 Percentage of Participants
|
|
Percentage Distribution of the Participant Score for Overall Product Rating at Week 6
2
|
2.1 Percentage of Participants
|
3.0 Percentage of Participants
|
|
Percentage Distribution of the Participant Score for Overall Product Rating at Week 6
3
|
4.5 Percentage of Participants
|
3.4 Percentage of Participants
|
|
Percentage Distribution of the Participant Score for Overall Product Rating at Week 6
6
|
8.9 Percentage of Participants
|
10.3 Percentage of Participants
|
|
Percentage Distribution of the Participant Score for Overall Product Rating at Week 6
7
|
18.7 Percentage of Participants
|
17.8 Percentage of Participants
|
|
Percentage Distribution of the Participant Score for Overall Product Rating at Week 6
8
|
22.3 Percentage of Participants
|
21.4 Percentage of Participants
|
|
Percentage Distribution of the Participant Score for Overall Product Rating at Week 6
9
|
8.3 Percentage of Participants
|
10.3 Percentage of Participants
|
|
Percentage Distribution of the Participant Score for Overall Product Rating at Week 6
10 (Excellent)
|
9.8 Percentage of Participants
|
15.6 Percentage of Participants
|
SECONDARY outcome
Timeframe: Week 12Population: Analysis was based on the Full Analysis Set which included all randomized participants.
Participants were asked to rate the investigational product on a 10-point scale of 1 - 10 (where 1=very poor and 10=excellent).
Outcome measures
| Measure |
Placebo
n=402 Participants
Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions
|
Nicotine
n=428 Participants
Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions
|
|---|---|---|
|
Percentage Distribution of the Participant Score for Overall Product Rating at Week 12
3
|
3.7 Percentage of Participants
|
3.3 Percentage of Participants
|
|
Percentage Distribution of the Participant Score for Overall Product Rating at Week 12
4
|
3.7 Percentage of Participants
|
2.1 Percentage of Participants
|
|
Percentage Distribution of the Participant Score for Overall Product Rating at Week 12
10 (Excellent)
|
14.2 Percentage of Participants
|
21.0 Percentage of Participants
|
|
Percentage Distribution of the Participant Score for Overall Product Rating at Week 12
1 (Very Poor)
|
5.5 Percentage of Participants
|
3.5 Percentage of Participants
|
|
Percentage Distribution of the Participant Score for Overall Product Rating at Week 12
2
|
3.5 Percentage of Participants
|
2.3 Percentage of Participants
|
|
Percentage Distribution of the Participant Score for Overall Product Rating at Week 12
5
|
11.4 Percentage of Participants
|
12.4 Percentage of Participants
|
|
Percentage Distribution of the Participant Score for Overall Product Rating at Week 12
6
|
10.0 Percentage of Participants
|
6.8 Percentage of Participants
|
|
Percentage Distribution of the Participant Score for Overall Product Rating at Week 12
7
|
16.7 Percentage of Participants
|
14.0 Percentage of Participants
|
|
Percentage Distribution of the Participant Score for Overall Product Rating at Week 12
8
|
20.4 Percentage of Participants
|
23.6 Percentage of Participants
|
|
Percentage Distribution of the Participant Score for Overall Product Rating at Week 12
9
|
10.9 Percentage of Participants
|
11.0 Percentage of Participants
|
SECONDARY outcome
Timeframe: Week 1Population: Analysis was based on the Full Analysis Set which included all randomized participants.
Participants were asked to rate the product in its effectiveness for dealing with desire/urge to smoke on a 5-point scale of 1 - 5 (where 1=not all effective and 5=extremely effective).
Outcome measures
| Measure |
Placebo
n=554 Participants
Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions
|
Nicotine
n=543 Participants
Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions
|
|---|---|---|
|
Percentage Distribution of the Participant Score for Product Effectiveness in Dealing With Desire/Urge to Smoke at Week 1
Not at all effective (1)
|
8.7 Percentage of Participants
|
4.2 Percentage of Participants
|
|
Percentage Distribution of the Participant Score for Product Effectiveness in Dealing With Desire/Urge to Smoke at Week 1
Somewhat effective (2)
|
27.8 Percentage of Participants
|
20.8 Percentage of Participants
|
|
Percentage Distribution of the Participant Score for Product Effectiveness in Dealing With Desire/Urge to Smoke at Week 1
Moderately effective (3)
|
34.5 Percentage of Participants
|
32.4 Percentage of Participants
|
|
Percentage Distribution of the Participant Score for Product Effectiveness in Dealing With Desire/Urge to Smoke at Week 1
Very effective (4)
|
23.3 Percentage of Participants
|
29.8 Percentage of Participants
|
|
Percentage Distribution of the Participant Score for Product Effectiveness in Dealing With Desire/Urge to Smoke at Week 1
Extremely effective (5)
|
5.8 Percentage of Participants
|
12.7 Percentage of Participants
|
SECONDARY outcome
Timeframe: Week 6Population: Analysis was based on the Full Analysis Set which included all randomized participants.
Participants were asked to rate the product in its effectiveness for dealing with desire/urge to smoke on a 5-point scale of 1 - 5 (where 1=not all effective and 5=extremely effective).
Outcome measures
| Measure |
Placebo
n=470 Participants
Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions
|
Nicotine
n=467 Participants
Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions
|
|---|---|---|
|
Percentage Distribution of the Participant Score for Product Effectiveness in Dealing With Desire/Urge to Smoke at Week 6
Very effective (4)
|
23.0 Percentage of Participants
|
31.0 Percentage of Participants
|
|
Percentage Distribution of the Participant Score for Product Effectiveness in Dealing With Desire/Urge to Smoke at Week 6
Not at all effective (1)
|
11.7 Percentage of Participants
|
5.4 Percentage of Participants
|
|
Percentage Distribution of the Participant Score for Product Effectiveness in Dealing With Desire/Urge to Smoke at Week 6
Somewhat effective (2)
|
26.8 Percentage of Participants
|
19.5 Percentage of Participants
|
|
Percentage Distribution of the Participant Score for Product Effectiveness in Dealing With Desire/Urge to Smoke at Week 6
Moderately effective (3)
|
31.7 Percentage of Participants
|
32.5 Percentage of Participants
|
|
Percentage Distribution of the Participant Score for Product Effectiveness in Dealing With Desire/Urge to Smoke at Week 6
Extremely effective (5)
|
6.8 Percentage of Participants
|
11.6 Percentage of Participants
|
SECONDARY outcome
Timeframe: Week 12Population: Analysis was based on the Full Analysis Set which included all randomized participants.
Participants were asked to rate the product in its effectiveness for dealing with desire/urge to smoke on a 5-point scale of 1 - 5 (where 1=not all effective and 5=extremely effective).
Outcome measures
| Measure |
Placebo
n=402 Participants
Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions
|
Nicotine
n=428 Participants
Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions
|
|---|---|---|
|
Percentage Distribution of the Participant Score for Product Effectiveness in Dealing With Desire/Urge to Smoke at Week 12
Moderately effective (3)
|
32.1 Percentage of Participants
|
29.7 Percentage of Participants
|
|
Percentage Distribution of the Participant Score for Product Effectiveness in Dealing With Desire/Urge to Smoke at Week 12
Extremely effective (5)
|
9.5 Percentage of Participants
|
17.8 Percentage of Participants
|
|
Percentage Distribution of the Participant Score for Product Effectiveness in Dealing With Desire/Urge to Smoke at Week 12
Not at all effective (1)
|
12.7 Percentage of Participants
|
6.8 Percentage of Participants
|
|
Percentage Distribution of the Participant Score for Product Effectiveness in Dealing With Desire/Urge to Smoke at Week 12
Somewhat effective (2)
|
20.1 Percentage of Participants
|
17.1 Percentage of Participants
|
|
Percentage Distribution of the Participant Score for Product Effectiveness in Dealing With Desire/Urge to Smoke at Week 12
Very effective (4)
|
25.6 Percentage of Participants
|
28.7 Percentage of Participants
|
SECONDARY outcome
Timeframe: Week 1Population: Analysis was based on the Full Analysis Set which included all randomized participants.
Participants were asked to rate the speed of action of the product on a 9-point scale of 1 - 9 (where 1=extremely slow and 9=extremely fast).
Outcome measures
| Measure |
Placebo
n=554 Participants
Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions
|
Nicotine
n=543 Participants
Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions
|
|---|---|---|
|
Percentage Distribution of the Participant Score for Speed of Action of the Product at Week 1
Extremely slow (1)
|
4.7 Percentage of Participants
|
1.8 Percentage of Participants
|
|
Percentage Distribution of the Participant Score for Speed of Action of the Product at Week 1
Very slow (2)
|
2.7 Percentage of Participants
|
1.5 Percentage of Participants
|
|
Percentage Distribution of the Participant Score for Speed of Action of the Product at Week 1
Moderately slow (3)
|
4.0 Percentage of Participants
|
2.0 Percentage of Participants
|
|
Percentage Distribution of the Participant Score for Speed of Action of the Product at Week 1
Slightly slow (4)
|
6.0 Percentage of Participants
|
2.8 Percentage of Participants
|
|
Percentage Distribution of the Participant Score for Speed of Action of the Product at Week 1
Neither fast nor slow (5)
|
21.8 Percentage of Participants
|
14.9 Percentage of Participants
|
|
Percentage Distribution of the Participant Score for Speed of Action of the Product at Week 1
Sightly fast (6)
|
10.5 Percentage of Participants
|
11.8 Percentage of Participants
|
|
Percentage Distribution of the Participant Score for Speed of Action of the Product at Week 1
Moderately fast (7)
|
24.2 Percentage of Participants
|
24.7 Percentage of Participants
|
|
Percentage Distribution of the Participant Score for Speed of Action of the Product at Week 1
Very fast (8)
|
17.9 Percentage of Participants
|
24.9 Percentage of Participants
|
|
Percentage Distribution of the Participant Score for Speed of Action of the Product at Week 1
Extremely fast (9)
|
8.3 Percentage of Participants
|
15.7 Percentage of Participants
|
SECONDARY outcome
Timeframe: Week 6Population: Analysis was based on the Full Analysis Set which included all randomized participants.
Participants were asked to rate the speed of action of the product on a 9-point scale of 1 - 9 (where 1=extremely slow and 9=extremely fast).
Outcome measures
| Measure |
Placebo
n=470 Participants
Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions
|
Nicotine
n=467 Participants
Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions
|
|---|---|---|
|
Percentage Distribution of the Participant Score for Speed of Action of the Product at Week 6
Moderately fast (7)
|
24.3 Percentage of Participants
|
25.3 Percentage of Participants
|
|
Percentage Distribution of the Participant Score for Speed of Action of the Product at Week 6
Extremely slow (1)
|
5.5 Percentage of Participants
|
2.8 Percentage of Participants
|
|
Percentage Distribution of the Participant Score for Speed of Action of the Product at Week 6
Very slow (2)
|
4.9 Percentage of Participants
|
2.4 Percentage of Participants
|
|
Percentage Distribution of the Participant Score for Speed of Action of the Product at Week 6
Moderately slow (3)
|
4.7 Percentage of Participants
|
3.9 Percentage of Participants
|
|
Percentage Distribution of the Participant Score for Speed of Action of the Product at Week 6
Slightly slow (4)
|
4.7 Percentage of Participants
|
3.6 Percentage of Participants
|
|
Percentage Distribution of the Participant Score for Speed of Action of the Product at Week 6
Neither fast nor slow (5)
|
20.2 Percentage of Participants
|
13.3 Percentage of Participants
|
|
Percentage Distribution of the Participant Score for Speed of Action of the Product at Week 6
Sightly fast (6)
|
11.9 Percentage of Participants
|
9.2 Percentage of Participants
|
|
Percentage Distribution of the Participant Score for Speed of Action of the Product at Week 6
Very fast (8)
|
18.3 Percentage of Participants
|
25.1 Percentage of Participants
|
|
Percentage Distribution of the Participant Score for Speed of Action of the Product at Week 6
Extremely fast (9)
|
5.5 Percentage of Participants
|
14.6 Percentage of Participants
|
SECONDARY outcome
Timeframe: Week 12Population: Analysis was based on the Full Analysis Set which included all randomized participants.
Participants were asked to rate the speed of action of the product on a 9-point scale of 1 - 9 (where 1=extremely slow and 9=extremely fast).
Outcome measures
| Measure |
Placebo
n=402 Participants
Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions
|
Nicotine
n=428 Participants
Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions
|
|---|---|---|
|
Percentage Distribution of the Participant Score for Speed of Action of the Product at Week 12
Slightly slow (4)
|
4.7 Percentage of Participants
|
3.3 Percentage of Participants
|
|
Percentage Distribution of the Participant Score for Speed of Action of the Product at Week 12
Moderately fast (7)
|
28.4 Percentage of Participants
|
21.7 Percentage of Participants
|
|
Percentage Distribution of the Participant Score for Speed of Action of the Product at Week 12
Extremely slow (1)
|
5.5 Percentage of Participants
|
4.0 Percentage of Participants
|
|
Percentage Distribution of the Participant Score for Speed of Action of the Product at Week 12
Very slow (2)
|
3.5 Percentage of Participants
|
1.6 Percentage of Participants
|
|
Percentage Distribution of the Participant Score for Speed of Action of the Product at Week 12
Moderately slow (3)
|
4.2 Percentage of Participants
|
2.6 Percentage of Participants
|
|
Percentage Distribution of the Participant Score for Speed of Action of the Product at Week 12
Neither fast nor slow (5)
|
19.4 Percentage of Participants
|
14.7 Percentage of Participants
|
|
Percentage Distribution of the Participant Score for Speed of Action of the Product at Week 12
Sightly fast (6)
|
8.5 Percentage of Participants
|
8.6 Percentage of Participants
|
|
Percentage Distribution of the Participant Score for Speed of Action of the Product at Week 12
Very fast (8)
|
17.9 Percentage of Participants
|
28.3 Percentage of Participants
|
|
Percentage Distribution of the Participant Score for Speed of Action of the Product at Week 12
Extremely fast (9)
|
8.0 Percentage of Participants
|
15.2 Percentage of Participants
|
SECONDARY outcome
Timeframe: Week 1Population: Analysis was based on the Full Analysis Set which included all randomized participants.
Participants were asked to rate their change of opinion concerning product compared to when first used product on a 5-point scale of 1 - 5 (where 1=I like it much less now and 5=I like it much more now).
Outcome measures
| Measure |
Placebo
n=554 Participants
Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions
|
Nicotine
n=543 Participants
Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions
|
|---|---|---|
|
Percentage Distribution of the Participant Score for Change of Opinion at Week 1 Concerning Product Compared to When First Used Product
I like it slightly more now (4)
|
26.4 Percentage of Participants
|
28.9 Percentage of Participants
|
|
Percentage Distribution of the Participant Score for Change of Opinion at Week 1 Concerning Product Compared to When First Used Product
I like it much less now (1)
|
2.5 Percentage of Participants
|
1.7 Percentage of Participants
|
|
Percentage Distribution of the Participant Score for Change of Opinion at Week 1 Concerning Product Compared to When First Used Product
I like it slightly less now (2)
|
4.3 Percentage of Participants
|
4.8 Percentage of Participants
|
|
Percentage Distribution of the Participant Score for Change of Opinion at Week 1 Concerning Product Compared to When First Used Product
I like it about the same (3)
|
50.9 Percentage of Participants
|
44.8 Percentage of Participants
|
|
Percentage Distribution of the Participant Score for Change of Opinion at Week 1 Concerning Product Compared to When First Used Product
I like it much more now (5)
|
15.9 Percentage of Participants
|
19.9 Percentage of Participants
|
SECONDARY outcome
Timeframe: Week 6Population: Analysis was based on the Full Analysis Set which included all randomized participants.
Participants were asked to rate their change of opinion concerning product compared to when first used product on a 5-point scale of 1 - 5 (where 1=I like it much less now and 5=I like it much more now).
Outcome measures
| Measure |
Placebo
n=470 Participants
Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions
|
Nicotine
n=467 Participants
Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions
|
|---|---|---|
|
Percentage Distribution of the Participant Score for Change of Opinion at Week 6 Concerning Product Compared to When First Used Product
I like it much less now (1)
|
4.7 Percentage of Participants
|
4.3 Percentage of Participants
|
|
Percentage Distribution of the Participant Score for Change of Opinion at Week 6 Concerning Product Compared to When First Used Product
I like it slightly less now (2)
|
11.9 Percentage of Participants
|
7.7 Percentage of Participants
|
|
Percentage Distribution of the Participant Score for Change of Opinion at Week 6 Concerning Product Compared to When First Used Product
I like it about the same (3)
|
47.9 Percentage of Participants
|
46.9 Percentage of Participants
|
|
Percentage Distribution of the Participant Score for Change of Opinion at Week 6 Concerning Product Compared to When First Used Product
I like it slightly more now (4)
|
22.3 Percentage of Participants
|
22.9 Percentage of Participants
|
|
Percentage Distribution of the Participant Score for Change of Opinion at Week 6 Concerning Product Compared to When First Used Product
I like it much more now (5)
|
13.2 Percentage of Participants
|
18.2 Percentage of Participants
|
SECONDARY outcome
Timeframe: Week 12Population: Analysis was based on the Full Analysis Set which included all randomized participants.
Participants were asked to rate their change of opinion concerning product compared to when first used product on a 5-point scale of 1 - 5 (where 1=I like it much less now and 5=I like it much more now).
Outcome measures
| Measure |
Placebo
n=402 Participants
Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions
|
Nicotine
n=428 Participants
Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions
|
|---|---|---|
|
Percentage Distribution of the Participant Score for Change of Opinion at Week 12 Concerning Product Compared to When First Used Product
I like it about the same (3)
|
46.0 Percentage of Participants
|
44.6 Percentage of Participants
|
|
Percentage Distribution of the Participant Score for Change of Opinion at Week 12 Concerning Product Compared to When First Used Product
I like it much less now (1)
|
9.0 Percentage of Participants
|
6.5 Percentage of Participants
|
|
Percentage Distribution of the Participant Score for Change of Opinion at Week 12 Concerning Product Compared to When First Used Product
I like it slightly less now (2)
|
9.0 Percentage of Participants
|
8.4 Percentage of Participants
|
|
Percentage Distribution of the Participant Score for Change of Opinion at Week 12 Concerning Product Compared to When First Used Product
I like it slightly more now (4)
|
18.7 Percentage of Participants
|
20.1 Percentage of Participants
|
|
Percentage Distribution of the Participant Score for Change of Opinion at Week 12 Concerning Product Compared to When First Used Product
I like it much more now (5)
|
17.4 Percentage of Participants
|
20.3 Percentage of Participants
|
SECONDARY outcome
Timeframe: Week 1Population: Analysis was based on the Full Analysis Set which included all randomized participants.
Participants were asked to rate the product convenience on a 5-point scale of 1 - 5 (where 1=not at all convenient and 5=extremely convenient).
Outcome measures
| Measure |
Placebo
n=554 Participants
Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions
|
Nicotine
n=543 Participants
Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions
|
|---|---|---|
|
Percentage Distribution of the Participant Score for Product Convenience at Week 1
Not at all convenient (1)
|
0.9 Percentage of Participants
|
0.2 Percentage of Participants
|
|
Percentage Distribution of the Participant Score for Product Convenience at Week 1
Somewhat convenient (2)
|
3.2 Percentage of Participants
|
3.7 Percentage of Participants
|
|
Percentage Distribution of the Participant Score for Product Convenience at Week 1
Moderately convenient (3)
|
10.1 Percentage of Participants
|
10.1 Percentage of Participants
|
|
Percentage Distribution of the Participant Score for Product Convenience at Week 1
Very convenient (4)
|
45.1 Percentage of Participants
|
41.6 Percentage of Participants
|
|
Percentage Distribution of the Participant Score for Product Convenience at Week 1
Extremely convenient (5)
|
40.6 Percentage of Participants
|
44.4 Percentage of Participants
|
SECONDARY outcome
Timeframe: Week 6Population: Analysis was based on the Full Analysis Set which included all randomized participants.
Participants were asked to rate the product convenience on a 5-point scale of 1 - 5 (where 1=not at all convenient and 5=extremely convenient).
Outcome measures
| Measure |
Placebo
n=470 Participants
Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions
|
Nicotine
n=467 Participants
Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions
|
|---|---|---|
|
Percentage Distribution of the Participant Score for Product Convenience at Week 6
Not at all convenient (1)
|
0.9 Percentage of Participants
|
0.4 Percentage of Participants
|
|
Percentage Distribution of the Participant Score for Product Convenience at Week 6
Somewhat convenient (2)
|
4.7 Percentage of Participants
|
3.4 Percentage of Participants
|
|
Percentage Distribution of the Participant Score for Product Convenience at Week 6
Moderately convenient (3)
|
8.7 Percentage of Participants
|
8.4 Percentage of Participants
|
|
Percentage Distribution of the Participant Score for Product Convenience at Week 6
Very convenient (4)
|
46.2 Percentage of Participants
|
50.1 Percentage of Participants
|
|
Percentage Distribution of the Participant Score for Product Convenience at Week 6
Extremely convenient (5)
|
39.6 Percentage of Participants
|
37.7 Percentage of Participants
|
SECONDARY outcome
Timeframe: Week 12Population: Analysis was based on the Full Analysis Set which included all randomized participants.
Participants were asked to rate the product convenience on a 5-point scale of 1 - 5 (where 1=not at all convenient and 5=extremely convenient).
Outcome measures
| Measure |
Placebo
n=402 Participants
Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions
|
Nicotine
n=428 Participants
Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions
|
|---|---|---|
|
Percentage Distribution of the Participant Score for Product Convenience at Week 12
Somewhat convenient (2)
|
3.0 Percentage of Participants
|
4.0 Percentage of Participants
|
|
Percentage Distribution of the Participant Score for Product Convenience at Week 12
Not at all convenient (1)
|
1.5 Percentage of Participants
|
0.2 Percentage of Participants
|
|
Percentage Distribution of the Participant Score for Product Convenience at Week 12
Moderately convenient (3)
|
9.0 Percentage of Participants
|
9.1 Percentage of Participants
|
|
Percentage Distribution of the Participant Score for Product Convenience at Week 12
Very convenient (4)
|
48.0 Percentage of Participants
|
44.2 Percentage of Participants
|
|
Percentage Distribution of the Participant Score for Product Convenience at Week 12
Extremely convenient (5)
|
38.6 Percentage of Participants
|
42.5 Percentage of Participants
|
SECONDARY outcome
Timeframe: Week 1Population: Analysis was based on the Safety Analysis Set which included all randomized participants who received study treatment.
Systolic blood pressure (mm Hg)
Outcome measures
| Measure |
Placebo
n=562 Participants
Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions
|
Nicotine
n=554 Participants
Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions
|
|---|---|---|
|
Systolic Blood Pressure at Week 1
|
123.7 mm Hg
Standard Deviation 15.54
|
124.7 mm Hg
Standard Deviation 15.84
|
SECONDARY outcome
Timeframe: Week 2Population: Analysis was based on the Safety Analysis Set which included all randomized participants who received study treatment.
Systolic blood pressure (mm Hg)
Outcome measures
| Measure |
Placebo
n=546 Participants
Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions
|
Nicotine
n=542 Participants
Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions
|
|---|---|---|
|
Systolic Blood Pressure at Week 2
|
123.3 mm Hg
Standard Deviation 15.42
|
123.7 mm Hg
Standard Deviation 15.50
|
SECONDARY outcome
Timeframe: Week 4Population: Analysis was based on the Safety Analysis Set which included all randomized participants who received study treatment.
Systolic blood pressure (mm Hg)
Outcome measures
| Measure |
Placebo
n=504 Participants
Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions
|
Nicotine
n=514 Participants
Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions
|
|---|---|---|
|
Systolic Blood Pressure at Week 4
|
122.5 mm Hg
Standard Deviation 15.29
|
122.9 mm Hg
Standard Deviation 15.55
|
SECONDARY outcome
Timeframe: Week 6Population: Analysis was based on the Safety Analysis Set which included all randomized participants who received study treatment.
Systolic blood pressure (mm Hg)
Outcome measures
| Measure |
Placebo
n=475 Participants
Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions
|
Nicotine
n=476 Participants
Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions
|
|---|---|---|
|
Systolic Blood Pressure at Week 6
|
122.3 mm Hg
Standard Deviation 14.05
|
122.4 mm Hg
Standard Deviation 15.04
|
SECONDARY outcome
Timeframe: Week 8Population: Analysis was based on the Safety Analysis Set which included all randomized participants who received study treatment.
Systolic blood pressure (mm Hg)
Outcome measures
| Measure |
Placebo
n=459 Participants
Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions
|
Nicotine
n=457 Participants
Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions
|
|---|---|---|
|
Systolic Blood Pressure at Week 8
|
122.0 mm Hg
Standard Deviation 14.52
|
122.7 mm Hg
Standard Deviation 14.86
|
SECONDARY outcome
Timeframe: Week 12Population: Analysis was based on the Safety Analysis Set which included all randomized participants who received study treatment.
Systolic blood pressure (mm Hg)
Outcome measures
| Measure |
Placebo
n=418 Participants
Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions
|
Nicotine
n=434 Participants
Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions
|
|---|---|---|
|
Systolic Blood Pressure at Week 12
|
121.8 mm Hg
Standard Deviation 15.02
|
122.7 mm Hg
Standard Deviation 15.81
|
SECONDARY outcome
Timeframe: Week 16Population: Analysis was based on the Safety Analysis Set which included all randomized participants who received study treatment.
Systolic blood pressure (mm Hg)
Outcome measures
| Measure |
Placebo
n=378 Participants
Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions
|
Nicotine
n=402 Participants
Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions
|
|---|---|---|
|
Systolic Blood Pressure at Week 16
|
122.3 mm Hg
Standard Deviation 14.94
|
122.8 mm Hg
Standard Deviation 15.25
|
SECONDARY outcome
Timeframe: Week 20Population: Analysis was based on the Safety Analysis Set which included all randomized participants who received study treatment.
Systolic blood pressure (mm Hg)
Outcome measures
| Measure |
Placebo
n=355 Participants
Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions
|
Nicotine
n=385 Participants
Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions
|
|---|---|---|
|
Systolic Blood Pressure at Week 20
|
122.4 mm Hg
Standard Deviation 15.40
|
123.2 mm Hg
Standard Deviation 15.41
|
SECONDARY outcome
Timeframe: Week 26Population: Analysis was based on the Safety Analysis Set which included all randomized participants who received study treatment.
Systolic blood pressure (mm Hg)
Outcome measures
| Measure |
Placebo
n=354 Participants
Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions
|
Nicotine
n=365 Participants
Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions
|
|---|---|---|
|
Systolic Blood Pressure at Week 26
|
123.2 mm Hg
Standard Deviation 14.44
|
124.8 mm Hg
Standard Deviation 15.07
|
SECONDARY outcome
Timeframe: Baseline to Week 1Population: Analysis was based on the Safety Analysis Set which included all randomized participants who received study treatment.
Change from baseline in systolic blood pressure (mm Hg)
Outcome measures
| Measure |
Placebo
n=562 Participants
Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions
|
Nicotine
n=554 Participants
Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions
|
|---|---|---|
|
Change From Baseline in Systolic Blood Pressure at Week 1
|
-0.2 mm Hg
Standard Deviation 13.49
|
0.2 mm Hg
Standard Deviation 13.94
|
SECONDARY outcome
Timeframe: Baseline to Week 2Population: Analysis was based on the Safety Analysis Set which included all randomized participants who received study treatment.
Change from baseline in systolic blood pressure (mm Hg)
Outcome measures
| Measure |
Placebo
n=546 Participants
Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions
|
Nicotine
n=542 Participants
Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions
|
|---|---|---|
|
Change From Baseline in Systolic Blood Pressure at Week 2
|
-0.7 mm Hg
Standard Deviation 14.06
|
-0.7 mm Hg
Standard Deviation 13.43
|
SECONDARY outcome
Timeframe: Baseline to Week 4Population: Analysis was based on the Safety Analysis Set which included all randomized participants who received study treatment.
Change from baseline in systolic blood pressure (mm Hg)
Outcome measures
| Measure |
Placebo
n=504 Participants
Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions
|
Nicotine
n=514 Participants
Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions
|
|---|---|---|
|
Change From Baseline in Systolic Blood Pressure at Week 4
|
-1.8 mm Hg
Standard Deviation 14.59
|
-1.9 mm Hg
Standard Deviation 14.52
|
SECONDARY outcome
Timeframe: Baseline to Week 6Population: Analysis was based on the Safety Analysis Set which included all randomized participants who received study treatment.
Change from baseline in systolic blood pressure (mm Hg)
Outcome measures
| Measure |
Placebo
n=475 Participants
Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions
|
Nicotine
n=476 Participants
Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions
|
|---|---|---|
|
Change From Baseline in Systolic Blood Pressure at Week 6
|
-2.0 mm Hg
Standard Deviation 14.80
|
-2.2 mm Hg
Standard Deviation 13.90
|
SECONDARY outcome
Timeframe: Baseline to Week 8Population: Analysis was based on the Safety Analysis Set which included all randomized participants who received study treatment.
Change from baseline in systolic blood pressure (mm Hg)
Outcome measures
| Measure |
Placebo
n=459 Participants
Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions
|
Nicotine
n=457 Participants
Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions
|
|---|---|---|
|
Change From Baseline in Systolic Blood Pressure at Week 8
|
-1.8 mm Hg
Standard Deviation 15.26
|
-2.2 mm Hg
Standard Deviation 14.61
|
SECONDARY outcome
Timeframe: Baseline to Week 12Population: Analysis was based on the Safety Analysis Set which included all randomized participants who received study treatment.
Change from baseline in systolic blood pressure (mm Hg)
Outcome measures
| Measure |
Placebo
n=418 Participants
Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions
|
Nicotine
n=434 Participants
Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions
|
|---|---|---|
|
Change From Baseline in Systolic Blood Pressure at Week 12
|
-2.2 mm Hg
Standard Deviation 15.75
|
-2.4 mm Hg
Standard Deviation 15.01
|
SECONDARY outcome
Timeframe: Baseline to Week 16Population: Analysis was based on the Safety Analysis Set which included all randomized participants who received study treatment.
Change from baseline in systolic blood pressure (mm Hg)
Outcome measures
| Measure |
Placebo
n=378 Participants
Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions
|
Nicotine
n=402 Participants
Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions
|
|---|---|---|
|
Change From Baseline in Systolic Blood Pressure at Week 16
|
-1.8 mm Hg
Standard Deviation 14.95
|
-2.8 mm Hg
Standard Deviation 15.57
|
SECONDARY outcome
Timeframe: Baseline to Week 20Population: Analysis was based on the Safety Analysis Set which included all randomized participants who received study treatment.
Change from baseline in systolic blood pressure (mm Hg)
Outcome measures
| Measure |
Placebo
n=355 Participants
Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions
|
Nicotine
n=385 Participants
Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions
|
|---|---|---|
|
Change From Baseline in Systolic Blood Pressure at Week 20
|
-1.7 mm Hg
Standard Deviation 15.15
|
-2.0 mm Hg
Standard Deviation 16.18
|
SECONDARY outcome
Timeframe: Baseline to Week 26Population: Analysis was based on the Safety Analysis Set which included all randomized participants who received study treatment.
Change from baseline in systolic blood pressure (mm Hg)
Outcome measures
| Measure |
Placebo
n=354 Participants
Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions
|
Nicotine
n=365 Participants
Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions
|
|---|---|---|
|
Change From Baseline in Systolic Blood Pressure at Week 26
|
-0.6 mm Hg
Standard Deviation 14.61
|
-0.6 mm Hg
Standard Deviation 15.37
|
SECONDARY outcome
Timeframe: Week 1Population: Analysis was based on the Safety Analysis Set which included all randomized participants who received study treatment.
Diastolic blood pressure (mm Hg)
Outcome measures
| Measure |
Placebo
n=562 Participants
Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions
|
Nicotine
n=554 Participants
Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions
|
|---|---|---|
|
Diastolic Blood Pressure at Week 1
|
77.3 mm Hg
Standard Deviation 9.54
|
78.0 mm Hg
Standard Deviation 9.99
|
SECONDARY outcome
Timeframe: Week 2Population: Analysis was based on the Safety Analysis Set which included all randomized participants who received study treatment.
Diastolic blood pressure (mm Hg)
Outcome measures
| Measure |
Placebo
n=546 Participants
Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions
|
Nicotine
n=542 Participants
Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions
|
|---|---|---|
|
Diastolic Blood Pressure at Week 2
|
76.7 mm Hg
Standard Deviation 9.72
|
78.0 mm Hg
Standard Deviation 10.03
|
SECONDARY outcome
Timeframe: Week 4Population: Analysis was based on the Safety Analysis Set which included all randomized participants who received study treatment.
Diastolic blood pressure (mm Hg)
Outcome measures
| Measure |
Placebo
n=504 Participants
Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions
|
Nicotine
n=514 Participants
Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions
|
|---|---|---|
|
Diastolic Blood Pressure at Week 4
|
76.9 mm Hg
Standard Deviation 9.58
|
77.6 mm Hg
Standard Deviation 9.86
|
SECONDARY outcome
Timeframe: Week 6Population: Analysis was based on the Safety Analysis Set which included all randomized participants who received study treatment.
Diastolic blood pressure (mm Hg)
Outcome measures
| Measure |
Placebo
n=475 Participants
Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions
|
Nicotine
n=476 Participants
Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions
|
|---|---|---|
|
Diastolic Blood Pressure at Week 6
|
76.6 mm Hg
Standard Deviation 9.86
|
76.5 mm Hg
Standard Deviation 9.49
|
SECONDARY outcome
Timeframe: Week 8Population: Analysis was based on the Safety Analysis Set which included all randomized participants who received study treatment.
Diastolic blood pressure (mm Hg)
Outcome measures
| Measure |
Placebo
n=459 Participants
Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions
|
Nicotine
n=457 Participants
Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions
|
|---|---|---|
|
Diastolic Blood Pressure at Week 8
|
76.5 mm Hg
Standard Deviation 9.82
|
77.3 mm Hg
Standard Deviation 9.35
|
SECONDARY outcome
Timeframe: Week 12Population: Analysis was based on the Safety Analysis Set which included all randomized participants who received study treatment.
Diastolic blood pressure (mm Hg)
Outcome measures
| Measure |
Placebo
n=418 Participants
Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions
|
Nicotine
n=434 Participants
Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions
|
|---|---|---|
|
Diastolic Blood Pressure at Week 12
|
76.6 mm Hg
Standard Deviation 10.12
|
77.4 mm Hg
Standard Deviation 10.25
|
SECONDARY outcome
Timeframe: Week 16Population: Analysis was based on the Safety Analysis Set which included all randomized participants who received study treatment.
Diastolic blood pressure (mm Hg)
Outcome measures
| Measure |
Placebo
n=378 Participants
Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions
|
Nicotine
n=402 Participants
Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions
|
|---|---|---|
|
Diastolic Blood Pressure at Week 16
|
76.4 mm Hg
Standard Deviation 9.43
|
77.0 mm Hg
Standard Deviation 10.10
|
SECONDARY outcome
Timeframe: Week 20Population: Analysis was based on the Safety Analysis Set which included all randomized participants who received study treatment.
Diastolic blood pressure (mm Hg)
Outcome measures
| Measure |
Placebo
n=355 Participants
Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions
|
Nicotine
n=385 Participants
Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions
|
|---|---|---|
|
Diastolic Blood Pressure at Week 20
|
76.3 mm Hg
Standard Deviation 9.91
|
76.8 mm Hg
Standard Deviation 10.50
|
SECONDARY outcome
Timeframe: Week 26Population: Analysis was based on the Safety Analysis Set which included all randomized participants who received study treatment.
Diastolic blood pressure (mm Hg)
Outcome measures
| Measure |
Placebo
n=354 Participants
Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions
|
Nicotine
n=365 Participants
Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions
|
|---|---|---|
|
Diastolic Blood Pressure at Week 26
|
76.9 mm Hg
Standard Deviation 9.21
|
78.1 mm Hg
Standard Deviation 10.13
|
SECONDARY outcome
Timeframe: Baseline to Week 1Population: Analysis was based on the Safety Analysis Set which included all randomized participants who received study treatment.
Change from baseline in diastolic blood pressure (mm Hg)
Outcome measures
| Measure |
Placebo
n=562 Participants
Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions
|
Nicotine
n=554 Participants
Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions
|
|---|---|---|
|
Change From Baseline in Diastolic Blood Pressure at Week 1
|
0.1 mm Hg
Standard Deviation 8.98
|
0.5 mm Hg
Standard Deviation 9.13
|
SECONDARY outcome
Timeframe: Baseline to Week 2Population: Analysis was based on the Safety Analysis Set which included all randomized participants who received study treatment.
Change from baseline in diastolic blood pressure (mm Hg)
Outcome measures
| Measure |
Placebo
n=546 Participants
Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions
|
Nicotine
n=542 Participants
Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions
|
|---|---|---|
|
Change From Baseline in Diastolic Blood Pressure at Week 2
|
-0.4 mm Hg
Standard Deviation 9.05
|
0.4 mm Hg
Standard Deviation 9.27
|
SECONDARY outcome
Timeframe: Baseline to Week 4Population: Analysis was based on the Safety Analysis Set which included all randomized participants who received study treatment.
Change from baseline in diastolic blood pressure (mm Hg)
Outcome measures
| Measure |
Placebo
n=504 Participants
Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions
|
Nicotine
n=514 Participants
Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions
|
|---|---|---|
|
Change From Baseline in Diastolic Blood Pressure at Week 4
|
-0.3 mm Hg
Standard Deviation 9.58
|
-0.1 mm Hg
Standard Deviation 9.38
|
SECONDARY outcome
Timeframe: Baseline to Week 6Population: Analysis was based on the Safety Analysis Set which included all randomized participants who received study treatment.
Change from baseline in diastolic blood pressure (mm Hg)
Outcome measures
| Measure |
Placebo
n=475 Participants
Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions
|
Nicotine
n=476 Participants
Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions
|
|---|---|---|
|
Change From Baseline in Diastolic Blood Pressure at Week 6
|
-0.6 mm Hg
Standard Deviation 9.87
|
-1.0 mm Hg
Standard Deviation 9.37
|
SECONDARY outcome
Timeframe: Baseline to Week 8Population: Analysis was based on the Safety Analysis Set which included all randomized participants who received study treatment.
Change from baseline in diastolic blood pressure (mm Hg)
Outcome measures
| Measure |
Placebo
n=459 Participants
Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions
|
Nicotine
n=457 Participants
Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions
|
|---|---|---|
|
Change From Baseline in Diastolic Blood Pressure at Week 8
|
-0.4 mm Hg
Standard Deviation 10.10
|
-0.1 mm Hg
Standard Deviation 10.39
|
SECONDARY outcome
Timeframe: Baseline to Week 12Population: Analysis was based on the Safety Analysis Set which included all randomized participants who received study treatment.
Change from baseline in diastolic blood pressure (mm Hg)
Outcome measures
| Measure |
Placebo
n=418 Participants
Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions
|
Nicotine
n=434 Participants
Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions
|
|---|---|---|
|
Change From Baseline in Diastolic Blood Pressure at Week 12
|
-0.4 mm Hg
Standard Deviation 10.06
|
-0.4 mm Hg
Standard Deviation 10.28
|
SECONDARY outcome
Timeframe: Baseline to Week 16Population: Analysis was based on the Safety Analysis Set which included all randomized participants who received study treatment.
Change from baseline in diastolic blood pressure (mm Hg)
Outcome measures
| Measure |
Placebo
n=378 Participants
Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions
|
Nicotine
n=402 Participants
Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions
|
|---|---|---|
|
Change From Baseline in Diastolic Blood Pressure at Week 16
|
-0.6 mm Hg
Standard Deviation 10.19
|
-0.8 mm Hg
Standard Deviation 9.86
|
SECONDARY outcome
Timeframe: Baseline to Week 20Population: Analysis was based on the Safety Analysis Set which included all randomized participants who received study treatment.
Change from baseline in diastolic blood pressure (mm Hg)
Outcome measures
| Measure |
Placebo
n=355 Participants
Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions
|
Nicotine
n=385 Participants
Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions
|
|---|---|---|
|
Change From Baseline in Diastolic Blood Pressure at Week 20
|
-0.8 mm Hg
Standard Deviation 10.07
|
-0.5 mm Hg
Standard Deviation 10.69
|
SECONDARY outcome
Timeframe: Baseline to Week 26Population: Analysis was based on the Safety Analysis Set which included all randomized participants who received study treatment.
Change from baseline in diastolic blood pressure (mm Hg)
Outcome measures
| Measure |
Placebo
n=354 Participants
Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions
|
Nicotine
n=365 Participants
Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions
|
|---|---|---|
|
Change From Baseline in Diastolic Blood Pressure at Week 26
|
-0.1 mm Hg
Standard Deviation 10.13
|
0.7 mm Hg
Standard Deviation 10.71
|
SECONDARY outcome
Timeframe: Week 1Population: Analysis was based on the Safety Analysis Set which included all randomized participants who received study treatment.
Pulse (beats per minute)
Outcome measures
| Measure |
Placebo
n=562 Participants
Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions
|
Nicotine
n=554 Participants
Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions
|
|---|---|---|
|
Pulse at Week 1
|
76.1 beats per minute
Standard Deviation 11.92
|
76.8 beats per minute
Standard Deviation 11.45
|
SECONDARY outcome
Timeframe: Week 2Population: Analysis was based on the Safety Analysis Set which included all randomized participants who received study treatment.
Pulse (beats per minute)
Outcome measures
| Measure |
Placebo
n=546 Participants
Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions
|
Nicotine
n=542 Participants
Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions
|
|---|---|---|
|
Pulse at Week 2
|
75.9 beats per minute
Standard Deviation 11.82
|
76.5 beats per minute
Standard Deviation 11.64
|
SECONDARY outcome
Timeframe: Week 4Population: Analysis was based on the Safety Analysis Set which included all randomized participants who received study treatment.
Pulse (beats per minute)
Outcome measures
| Measure |
Placebo
n=504 Participants
Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions
|
Nicotine
n=514 Participants
Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions
|
|---|---|---|
|
Pulse at Week 4
|
75.6 beats per minute
Standard Deviation 11.77
|
77.0 beats per minute
Standard Deviation 11.72
|
SECONDARY outcome
Timeframe: Week 6Population: Analysis was based on the Safety Analysis Set which included all randomized participants who received study treatment.
Pulse (beats per minute)
Outcome measures
| Measure |
Placebo
n=474 Participants
Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions
|
Nicotine
n=475 Participants
Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions
|
|---|---|---|
|
Pulse at Week 6
|
75.3 beats per minute
Standard Deviation 11.41
|
75.2 beats per minute
Standard Deviation 11.37
|
SECONDARY outcome
Timeframe: Week 8Population: Analysis was based on the Safety Analysis Set which included all randomized participants who received study treatment.
Pulse (beats per minute)
Outcome measures
| Measure |
Placebo
n=459 Participants
Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions
|
Nicotine
n=456 Participants
Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions
|
|---|---|---|
|
Pulse at Week 8
|
75.4 beats per minute
Standard Deviation 11.69
|
77.3 beats per minute
Standard Deviation 11.27
|
SECONDARY outcome
Timeframe: Week 12Population: Analysis was based on the Safety Analysis Set which included all randomized participants who received study treatment.
Pulse (beats per minute)
Outcome measures
| Measure |
Placebo
n=417 Participants
Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions
|
Nicotine
n=434 Participants
Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions
|
|---|---|---|
|
Pulse at Week 12
|
75.1 beats per minute
Standard Deviation 11.46
|
76.1 beats per minute
Standard Deviation 11.02
|
SECONDARY outcome
Timeframe: Week 16Population: Analysis was based on the Safety Analysis Set which included all randomized participants who received study treatment.
Pulse (beats per minute)
Outcome measures
| Measure |
Placebo
n=378 Participants
Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions
|
Nicotine
n=402 Participants
Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions
|
|---|---|---|
|
Pulse at Week 16
|
76.9 beats per minute
Standard Deviation 11.94
|
76.2 beats per minute
Standard Deviation 11.46
|
SECONDARY outcome
Timeframe: Week 20Population: Analysis was based on the Safety Analysis Set which included all randomized participants who received study treatment.
Pulse (beats per minute)
Outcome measures
| Measure |
Placebo
n=355 Participants
Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions
|
Nicotine
n=385 Participants
Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions
|
|---|---|---|
|
Pulse at Week 20
|
76.4 beats per minute
Standard Deviation 11.70
|
76.2 beats per minute
Standard Deviation 11.58
|
SECONDARY outcome
Timeframe: Week 26Population: Analysis was based on the Safety Analysis Set which included all randomized participants who received study treatment.
Pulse (beats per minute)
Outcome measures
| Measure |
Placebo
n=354 Participants
Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions
|
Nicotine
n=365 Participants
Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions
|
|---|---|---|
|
Pulse at Week 26
|
76.9 beats per minute
Standard Deviation 11.98
|
76.0 beats per minute
Standard Deviation 10.85
|
SECONDARY outcome
Timeframe: Baseline to Week 1Population: Analysis was based on the Safety Analysis Set which included all randomized participants who received study treatment.
Change from baseline in pulse (beats per minute)
Outcome measures
| Measure |
Placebo
n=562 Participants
Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions
|
Nicotine
n=554 Participants
Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions
|
|---|---|---|
|
Change From Baseline in Pulse at Week 1
|
1.4 beats per minute
Standard Deviation 10.69
|
2.0 beats per minute
Standard Deviation 10.80
|
SECONDARY outcome
Timeframe: Baseline to Week 2Population: Analysis was based on the Safety Analysis Set which included all randomized participants who received study treatment.
Change from baseline in pulse (beats per minute)
Outcome measures
| Measure |
Placebo
n=546 Participants
Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions
|
Nicotine
n=542 Participants
Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions
|
|---|---|---|
|
Change From Baseline in Pulse at Week 2
|
1.2 beats per minute
Standard Deviation 10.75
|
1.8 beats per minute
Standard Deviation 10.95
|
SECONDARY outcome
Timeframe: Baseline to Week 4Population: Analysis was based on the Safety Analysis Set which included all randomized participants who received study treatment.
Change from baseline in pulse (beats per minute)
Outcome measures
| Measure |
Placebo
n=504 Participants
Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions
|
Nicotine
n=514 Participants
Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions
|
|---|---|---|
|
Change From Baseline in Pulse at Week 4
|
1.3 beats per minute
Standard Deviation 11.42
|
2.4 beats per minute
Standard Deviation 11.51
|
SECONDARY outcome
Timeframe: Baseline to Week 6Population: Analysis was based on the Safety Analysis Set which included all randomized participants who received study treatment.
Change from baseline in pulse (beats per minute)
Outcome measures
| Measure |
Placebo
n=474 Participants
Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions
|
Nicotine
n=475 Participants
Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions
|
|---|---|---|
|
Change From Baseline in Pulse at Week 6
|
1.0 beats per minute
Standard Deviation 11.23
|
0.7 beats per minute
Standard Deviation 11.44
|
SECONDARY outcome
Timeframe: Baseline to Week 8Population: Analysis was based on the Safety Analysis Set which included all randomized participants who received study treatment.
Change from baseline in pulse (beats per minute)
Outcome measures
| Measure |
Placebo
n=459 Participants
Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions
|
Nicotine
n=456 Participants
Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions
|
|---|---|---|
|
Change From Baseline in Pulse at Week 8
|
1.2 beats per minute
Standard Deviation 11.51
|
2.7 beats per minute
Standard Deviation 11.96
|
SECONDARY outcome
Timeframe: Baseline to Week 12Population: Analysis was based on the Safety Analysis Set which included all randomized participants who received study treatment.
Change from baseline in pulse (beats per minute)
Outcome measures
| Measure |
Placebo
n=417 Participants
Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions
|
Nicotine
n=434 Participants
Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions
|
|---|---|---|
|
Change From Baseline in Pulse at Week 12
|
0.9 beats per minute
Standard Deviation 11.09
|
1.8 beats per minute
Standard Deviation 10.84
|
SECONDARY outcome
Timeframe: Baseline to Week 16Population: Analysis was based on the Safety Analysis Set which included all randomized participants who received study treatment.
Change from baseline in pulse (beats per minute)
Outcome measures
| Measure |
Placebo
n=378 Participants
Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions
|
Nicotine
n=402 Participants
Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions
|
|---|---|---|
|
Change From Baseline in Pulse at Week 16
|
2.8 beats per minute
Standard Deviation 11.58
|
1.9 beats per minute
Standard Deviation 11.50
|
SECONDARY outcome
Timeframe: Baseline to Week 20Population: Analysis was based on the Safety Analysis Set which included all randomized participants who received study treatment.
Change from baseline in pulse (beats per minute)
Outcome measures
| Measure |
Placebo
n=355 Participants
Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions
|
Nicotine
n=385 Participants
Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions
|
|---|---|---|
|
Change From Baseline in Pulse at Week 20
|
2.7 beats per minute
Standard Deviation 11.25
|
2.0 beats per minute
Standard Deviation 10.96
|
SECONDARY outcome
Timeframe: Baseline to Week 26Population: Analysis was based on the Safety Analysis Set which included all randomized participants who received study treatment.
Change from baseline in pulse (beats per minute)
Outcome measures
| Measure |
Placebo
n=354 Participants
Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions
|
Nicotine
n=365 Participants
Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions
|
|---|---|---|
|
Change From Baseline in Pulse at Week 26
|
3.2 beats per minute
Standard Deviation 11.16
|
1.8 beats per minute
Standard Deviation 11.29
|
SECONDARY outcome
Timeframe: Week 6 or when withdrawn from studyPopulation: Analysis was based on the Safety Analysis Set which included all randomized participants who received study treatment.
Visual mouth inspection (VMI) performed at the site or local dental office by a licensed dentist or an examiner such as a dental hygienist with documented training in oral clinical exams. Extraoral and intraoral tissues were examined. Abnormalities were recorded; it was determined if abnormalities were new or had worsened since baseline VMI findings.
Outcome measures
| Measure |
Placebo
n=495 Participants
Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions
|
Nicotine
n=495 Participants
Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions
|
|---|---|---|
|
Percentage of Participants With New or Worsened Conditions in Lips/Labial Mucosa at Week 6 or When Withdrawn From Study
|
0.4 Percentage of Participants
|
1.0 Percentage of Participants
|
SECONDARY outcome
Timeframe: Week 6 or when withdrawn from studyPopulation: Analysis was based on the Safety Analysis Set which included all randomized participants who received study treatment.
Visual mouth inspection (VMI) performed at the site or local dental office by a licensed dentist or an examiner such as a dental hygienist with documented training in oral clinical exams. Extraoral and intraoral tissues were examined. Abnormalities were recorded; it was determined if abnormalities were new or had worsened since baseline VMI findings.
Outcome measures
| Measure |
Placebo
n=495 Participants
Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions
|
Nicotine
n=495 Participants
Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions
|
|---|---|---|
|
Percentage of Participants With New or Worsened Conditions in Buccal Mucosa at Week 6 or When Withdrawn From Study
|
1.2 Percentage of Participants
|
1.6 Percentage of Participants
|
SECONDARY outcome
Timeframe: Week 6 or when withdrawn from studyPopulation: Analysis was based on the Safety Analysis Set which included all randomized participants who received study treatment.
Visual mouth inspection (VMI) performed at the site or local dental office by a licensed dentist or an examiner such as a dental hygienist with documented training in oral clinical exams. Extraoral and intraoral tissues were examined. Abnormalities were recorded; it was determined if abnormalities were new or had worsened since baseline VMI findings.
Outcome measures
| Measure |
Placebo
n=495 Participants
Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions
|
Nicotine
n=494 Participants
Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions
|
|---|---|---|
|
Percentage of Participants With New or Worsened Conditions in Mucobuccal Fold at Week 6 or When Withdrawn From Study
|
0.2 Percentage of Participants
|
0.0 Percentage of Participants
|
SECONDARY outcome
Timeframe: Week 6 or when withdrawn from studyPopulation: Analysis was based on the Safety Analysis Set which included all randomized participants who received study treatment.
Visual mouth inspection (VMI) performed at the site or local dental office by a licensed dentist or an examiner such as a dental hygienist with documented training in oral clinical exams. Extraoral and intraoral tissues were examined. Abnormalities were recorded; it was determined if abnormalities were new or had worsened since baseline VMI findings.
Outcome measures
| Measure |
Placebo
n=495 Participants
Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions
|
Nicotine
n=495 Participants
Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions
|
|---|---|---|
|
Percentage of Participants With New or Worsened Conditions in Sublingual Mucosa at Week 6 or When Withdrawn From Study
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
SECONDARY outcome
Timeframe: Week 6 or when withdrawn from studyPopulation: Analysis was based on the Safety Analysis Set which included all randomized participants who received study treatment.
Visual mouth inspection (VMI) performed at the site or local dental office by a licensed dentist or an examiner such as a dental hygienist with documented training in oral clinical exams. Extraoral and intraoral tissues were examined. Abnormalities were recorded; it was determined if abnormalities were new or had worsened since baseline VMI findings.
Outcome measures
| Measure |
Placebo
n=495 Participants
Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions
|
Nicotine
n=495 Participants
Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions
|
|---|---|---|
|
Percentage of Participants With New or Worsened Conditions in Gingiva at Week 6 or When Withdrawn From Study
|
0.2 Percentage of Participants
|
1.0 Percentage of Participants
|
SECONDARY outcome
Timeframe: Week 6 or when withdrawn from studyPopulation: Analysis was based on the Safety Analysis Set which included all randomized participants who received study treatment.
Visual mouth inspection (VMI) performed at the site or local dental office by a licensed dentist or an examiner such as a dental hygienist with documented training in oral clinical exams. Extraoral and intraoral tissues were examined. Abnormalities were recorded; it was determined if abnormalities were new or had worsened since baseline VMI findings.
Outcome measures
| Measure |
Placebo
n=495 Participants
Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions
|
Nicotine
n=495 Participants
Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions
|
|---|---|---|
|
Percentage of Participants With New or Worsened Conditions in Tongue at Week 6 or When Withdrawn From Study
|
0.8 Percentage of Participants
|
0.8 Percentage of Participants
|
SECONDARY outcome
Timeframe: Week 6 or when withdrawn from studyPopulation: Analysis was based on the Safety Analysis Set which included all randomized participants who received study treatment.
Visual mouth inspection (VMI) performed at the site or local dental office by a licensed dentist or an examiner such as a dental hygienist with documented training in oral clinical exams. Extraoral and intraoral tissues were examined. Abnormalities were recorded; it was determined if abnormalities were new or had worsened since baseline VMI findings.
Outcome measures
| Measure |
Placebo
n=495 Participants
Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions
|
Nicotine
n=495 Participants
Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions
|
|---|---|---|
|
Percentage of Participants With New or Worsened Conditions in Hard/Soft Palate at Week 6 or When Withdrawn From Study
|
0.4 Percentage of Participants
|
1.0 Percentage of Participants
|
SECONDARY outcome
Timeframe: Week 6 or when withdrawn from studyPopulation: Analysis was based on the Safety Analysis Set which included all randomized participants who received study treatment.
Visual mouth inspection (VMI) performed at the site or local dental office by a licensed dentist or an examiner such as a dental hygienist with documented training in oral clinical exams. Extraoral and intraoral tissues were examined. Abnormalities were recorded; it was determined if abnormalities were new or had worsened since baseline VMI findings.
Outcome measures
| Measure |
Placebo
n=495 Participants
Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions
|
Nicotine
n=495 Participants
Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions
|
|---|---|---|
|
Percentage of Participants With New or Worsened Conditions in Uvula/Oropharynx at Week 6 or When Withdrawn From Study
|
0.4 Percentage of Participants
|
0.2 Percentage of Participants
|
SECONDARY outcome
Timeframe: Week 6 or when withdrawn from studyPopulation: Analysis was based on the Safety Analysis Set which included all randomized participants who received study treatment.
Visual mouth inspection (VMI) performed at the site or local dental office by a licensed dentist or an examiner such as a dental hygienist with documented training in oral clinical exams. Extraoral and intraoral tissues were examined. Abnormalities were recorded; it was determined if abnormalities were new or had worsened since baseline VMI findings.
Outcome measures
| Measure |
Placebo
n=495 Participants
Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions
|
Nicotine
n=495 Participants
Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions
|
|---|---|---|
|
Percentage of Participants With New or Worsened Conditions in Visual Mouth Inspection Overall at Week 6 or When Withdrawn From Study
|
1.8 Percentage of Participants
|
3.6 Percentage of Participants
|
SECONDARY outcome
Timeframe: Baseline to Week 6Population: Analysis was based on the Full Analysis Set which included all randomized participants.
Change from baseline in body weight
Outcome measures
| Measure |
Placebo
n=471 Participants
Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions
|
Nicotine
n=472 Participants
Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions
|
|---|---|---|
|
Change From Baseline in Body Weight at Week 6
|
0.5 pounds
Standard Deviation 5.73
|
0.7 pounds
Standard Deviation 6.29
|
SECONDARY outcome
Timeframe: Baseline to Week 12Population: Analysis was based on the Full Analysis Set which included all randomized participants.
Change from baseline in body weight
Outcome measures
| Measure |
Placebo
n=411 Participants
Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions
|
Nicotine
n=432 Participants
Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions
|
|---|---|---|
|
Change From Baseline in Body Weight at Week 12
|
-0.3 pounds
Standard Deviation 7.40
|
0.4 pounds
Standard Deviation 6.89
|
SECONDARY outcome
Timeframe: Baseline to Week 26Population: Analysis was based on the Full Analysis Set which included all randomized participants.
Change from baseline in body weight
Outcome measures
| Measure |
Placebo
n=351 Participants
Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions
|
Nicotine
n=366 Participants
Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions
|
|---|---|---|
|
Change From Baseline in Body Weight at Week 26
|
-0.2 pounds
Standard Deviation 11.07
|
1.0 pounds
Standard Deviation 8.43
|
SECONDARY outcome
Timeframe: Baseline to Week 6Population: Analysis was based on randomized participants verified continuously abstinent from smoking since the Week 2 visit.
Change from baseline in body weight
Outcome measures
| Measure |
Placebo
n=14 Participants
Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions
|
Nicotine
n=30 Participants
Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions
|
|---|---|---|
|
Change From Baseline in Body Weight at Week 6 in Participants Verified Continuously Abstinent From Smoking From the Week 2 Visit
|
3.6 pounds
Standard Deviation 5.93
|
3.7 pounds
Standard Deviation 5.79
|
SECONDARY outcome
Timeframe: Baseline to Week 12Population: Analysis was based on randomized participants verified continuously abstinent from smoking since the Week 2 visit.
Change from baseline in body weight
Outcome measures
| Measure |
Placebo
n=8 Participants
Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions
|
Nicotine
n=24 Participants
Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions
|
|---|---|---|
|
Change From Baseline in Body Weight at Week 12 in Participants Verified Continuously Abstinent From Smoking From the Week 2 Visit
|
4.2 pounds
Standard Deviation 8.89
|
6.4 pounds
Standard Deviation 6.92
|
SECONDARY outcome
Timeframe: Baseline to Week 26Population: Analysis was based on randomized participants verified continuously abstinent from smoking since the Week 2 visit.
Change from baseline in body weight
Outcome measures
| Measure |
Placebo
n=6 Participants
Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions
|
Nicotine
n=20 Participants
Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions
|
|---|---|---|
|
Change From Baseline in Body Weight at Week 26 in Participants Verified Continuously Abstinent From Smoking From the Week 2 Visit
|
2.5 pounds
Standard Deviation 5.67
|
9.3 pounds
Standard Deviation 9.52
|
Adverse Events
Placebo
Serious events: 14 serious events
Other events: 140 other events
Deaths: 0 deaths
Nicotine
Serious events: 20 serious events
Other events: 349 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=601 participants at risk
Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions
|
Nicotine
n=597 participants at risk
Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions
|
|---|---|---|
|
Cardiac disorders
Atrial Fibrillation
|
0.00%
0/601 • Through 26-week end-of-study visit or through early termination visit; + up to 30 days for unresolved adverse events; +30 days for serious adverse events
AEs were systematically collected during the study. AEs that were unresolved upon completion or termination from the study were followed for up to 30 calendar days until the event or its sequelae resolved or stabilized. Serious AEs were collected through 30 calendar days after the participant's last study visit.
|
0.17%
1/597 • Through 26-week end-of-study visit or through early termination visit; + up to 30 days for unresolved adverse events; +30 days for serious adverse events
AEs were systematically collected during the study. AEs that were unresolved upon completion or termination from the study were followed for up to 30 calendar days until the event or its sequelae resolved or stabilized. Serious AEs were collected through 30 calendar days after the participant's last study visit.
|
|
Cardiac disorders
Angina Unstable
|
0.17%
1/601 • Through 26-week end-of-study visit or through early termination visit; + up to 30 days for unresolved adverse events; +30 days for serious adverse events
AEs were systematically collected during the study. AEs that were unresolved upon completion or termination from the study were followed for up to 30 calendar days until the event or its sequelae resolved or stabilized. Serious AEs were collected through 30 calendar days after the participant's last study visit.
|
0.00%
0/597 • Through 26-week end-of-study visit or through early termination visit; + up to 30 days for unresolved adverse events; +30 days for serious adverse events
AEs were systematically collected during the study. AEs that were unresolved upon completion or termination from the study were followed for up to 30 calendar days until the event or its sequelae resolved or stabilized. Serious AEs were collected through 30 calendar days after the participant's last study visit.
|
|
Cardiac disorders
Cardiac Arrest
|
0.00%
0/601 • Through 26-week end-of-study visit or through early termination visit; + up to 30 days for unresolved adverse events; +30 days for serious adverse events
AEs were systematically collected during the study. AEs that were unresolved upon completion or termination from the study were followed for up to 30 calendar days until the event or its sequelae resolved or stabilized. Serious AEs were collected through 30 calendar days after the participant's last study visit.
|
0.17%
1/597 • Through 26-week end-of-study visit or through early termination visit; + up to 30 days for unresolved adverse events; +30 days for serious adverse events
AEs were systematically collected during the study. AEs that were unresolved upon completion or termination from the study were followed for up to 30 calendar days until the event or its sequelae resolved or stabilized. Serious AEs were collected through 30 calendar days after the participant's last study visit.
|
|
Endocrine disorders
Secondary Adrenocortical Insufficiency
|
0.00%
0/601 • Through 26-week end-of-study visit or through early termination visit; + up to 30 days for unresolved adverse events; +30 days for serious adverse events
AEs were systematically collected during the study. AEs that were unresolved upon completion or termination from the study were followed for up to 30 calendar days until the event or its sequelae resolved or stabilized. Serious AEs were collected through 30 calendar days after the participant's last study visit.
|
0.17%
1/597 • Through 26-week end-of-study visit or through early termination visit; + up to 30 days for unresolved adverse events; +30 days for serious adverse events
AEs were systematically collected during the study. AEs that were unresolved upon completion or termination from the study were followed for up to 30 calendar days until the event or its sequelae resolved or stabilized. Serious AEs were collected through 30 calendar days after the participant's last study visit.
|
|
Eye disorders
Blindness Unilateral
|
0.00%
0/601 • Through 26-week end-of-study visit or through early termination visit; + up to 30 days for unresolved adverse events; +30 days for serious adverse events
AEs were systematically collected during the study. AEs that were unresolved upon completion or termination from the study were followed for up to 30 calendar days until the event or its sequelae resolved or stabilized. Serious AEs were collected through 30 calendar days after the participant's last study visit.
|
0.17%
1/597 • Through 26-week end-of-study visit or through early termination visit; + up to 30 days for unresolved adverse events; +30 days for serious adverse events
AEs were systematically collected during the study. AEs that were unresolved upon completion or termination from the study were followed for up to 30 calendar days until the event or its sequelae resolved or stabilized. Serious AEs were collected through 30 calendar days after the participant's last study visit.
|
|
Eye disorders
Retinal Oedema
|
0.00%
0/601 • Through 26-week end-of-study visit or through early termination visit; + up to 30 days for unresolved adverse events; +30 days for serious adverse events
AEs were systematically collected during the study. AEs that were unresolved upon completion or termination from the study were followed for up to 30 calendar days until the event or its sequelae resolved or stabilized. Serious AEs were collected through 30 calendar days after the participant's last study visit.
|
0.17%
1/597 • Through 26-week end-of-study visit or through early termination visit; + up to 30 days for unresolved adverse events; +30 days for serious adverse events
AEs were systematically collected during the study. AEs that were unresolved upon completion or termination from the study were followed for up to 30 calendar days until the event or its sequelae resolved or stabilized. Serious AEs were collected through 30 calendar days after the participant's last study visit.
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/601 • Through 26-week end-of-study visit or through early termination visit; + up to 30 days for unresolved adverse events; +30 days for serious adverse events
AEs were systematically collected during the study. AEs that were unresolved upon completion or termination from the study were followed for up to 30 calendar days until the event or its sequelae resolved or stabilized. Serious AEs were collected through 30 calendar days after the participant's last study visit.
|
0.17%
1/597 • Through 26-week end-of-study visit or through early termination visit; + up to 30 days for unresolved adverse events; +30 days for serious adverse events
AEs were systematically collected during the study. AEs that were unresolved upon completion or termination from the study were followed for up to 30 calendar days until the event or its sequelae resolved or stabilized. Serious AEs were collected through 30 calendar days after the participant's last study visit.
|
|
Gastrointestinal disorders
Gastrooesophageal Reflux Disease
|
0.00%
0/601 • Through 26-week end-of-study visit or through early termination visit; + up to 30 days for unresolved adverse events; +30 days for serious adverse events
AEs were systematically collected during the study. AEs that were unresolved upon completion or termination from the study were followed for up to 30 calendar days until the event or its sequelae resolved or stabilized. Serious AEs were collected through 30 calendar days after the participant's last study visit.
|
0.17%
1/597 • Through 26-week end-of-study visit or through early termination visit; + up to 30 days for unresolved adverse events; +30 days for serious adverse events
AEs were systematically collected during the study. AEs that were unresolved upon completion or termination from the study were followed for up to 30 calendar days until the event or its sequelae resolved or stabilized. Serious AEs were collected through 30 calendar days after the participant's last study visit.
|
|
Gastrointestinal disorders
Large Intestine Perforation
|
0.17%
1/601 • Through 26-week end-of-study visit or through early termination visit; + up to 30 days for unresolved adverse events; +30 days for serious adverse events
AEs were systematically collected during the study. AEs that were unresolved upon completion or termination from the study were followed for up to 30 calendar days until the event or its sequelae resolved or stabilized. Serious AEs were collected through 30 calendar days after the participant's last study visit.
|
0.00%
0/597 • Through 26-week end-of-study visit or through early termination visit; + up to 30 days for unresolved adverse events; +30 days for serious adverse events
AEs were systematically collected during the study. AEs that were unresolved upon completion or termination from the study were followed for up to 30 calendar days until the event or its sequelae resolved or stabilized. Serious AEs were collected through 30 calendar days after the participant's last study visit.
|
|
Gastrointestinal disorders
Small Intestinal Obstruction
|
0.00%
0/601 • Through 26-week end-of-study visit or through early termination visit; + up to 30 days for unresolved adverse events; +30 days for serious adverse events
AEs were systematically collected during the study. AEs that were unresolved upon completion or termination from the study were followed for up to 30 calendar days until the event or its sequelae resolved or stabilized. Serious AEs were collected through 30 calendar days after the participant's last study visit.
|
0.17%
1/597 • Through 26-week end-of-study visit or through early termination visit; + up to 30 days for unresolved adverse events; +30 days for serious adverse events
AEs were systematically collected during the study. AEs that were unresolved upon completion or termination from the study were followed for up to 30 calendar days until the event or its sequelae resolved or stabilized. Serious AEs were collected through 30 calendar days after the participant's last study visit.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/601 • Through 26-week end-of-study visit or through early termination visit; + up to 30 days for unresolved adverse events; +30 days for serious adverse events
AEs were systematically collected during the study. AEs that were unresolved upon completion or termination from the study were followed for up to 30 calendar days until the event or its sequelae resolved or stabilized. Serious AEs were collected through 30 calendar days after the participant's last study visit.
|
0.17%
1/597 • Through 26-week end-of-study visit or through early termination visit; + up to 30 days for unresolved adverse events; +30 days for serious adverse events
AEs were systematically collected during the study. AEs that were unresolved upon completion or termination from the study were followed for up to 30 calendar days until the event or its sequelae resolved or stabilized. Serious AEs were collected through 30 calendar days after the participant's last study visit.
|
|
General disorders
Sudden Death
|
0.17%
1/601 • Through 26-week end-of-study visit or through early termination visit; + up to 30 days for unresolved adverse events; +30 days for serious adverse events
AEs were systematically collected during the study. AEs that were unresolved upon completion or termination from the study were followed for up to 30 calendar days until the event or its sequelae resolved or stabilized. Serious AEs were collected through 30 calendar days after the participant's last study visit.
|
0.00%
0/597 • Through 26-week end-of-study visit or through early termination visit; + up to 30 days for unresolved adverse events; +30 days for serious adverse events
AEs were systematically collected during the study. AEs that were unresolved upon completion or termination from the study were followed for up to 30 calendar days until the event or its sequelae resolved or stabilized. Serious AEs were collected through 30 calendar days after the participant's last study visit.
|
|
Hepatobiliary disorders
Cholecystitis Acute
|
0.17%
1/601 • Through 26-week end-of-study visit or through early termination visit; + up to 30 days for unresolved adverse events; +30 days for serious adverse events
AEs were systematically collected during the study. AEs that were unresolved upon completion or termination from the study were followed for up to 30 calendar days until the event or its sequelae resolved or stabilized. Serious AEs were collected through 30 calendar days after the participant's last study visit.
|
0.00%
0/597 • Through 26-week end-of-study visit or through early termination visit; + up to 30 days for unresolved adverse events; +30 days for serious adverse events
AEs were systematically collected during the study. AEs that were unresolved upon completion or termination from the study were followed for up to 30 calendar days until the event or its sequelae resolved or stabilized. Serious AEs were collected through 30 calendar days after the participant's last study visit.
|
|
Infections and infestations
Abdominal Abscess
|
0.17%
1/601 • Through 26-week end-of-study visit or through early termination visit; + up to 30 days for unresolved adverse events; +30 days for serious adverse events
AEs were systematically collected during the study. AEs that were unresolved upon completion or termination from the study were followed for up to 30 calendar days until the event or its sequelae resolved or stabilized. Serious AEs were collected through 30 calendar days after the participant's last study visit.
|
0.00%
0/597 • Through 26-week end-of-study visit or through early termination visit; + up to 30 days for unresolved adverse events; +30 days for serious adverse events
AEs were systematically collected during the study. AEs that were unresolved upon completion or termination from the study were followed for up to 30 calendar days until the event or its sequelae resolved or stabilized. Serious AEs were collected through 30 calendar days after the participant's last study visit.
|
|
Infections and infestations
Appendicitis
|
0.00%
0/601 • Through 26-week end-of-study visit or through early termination visit; + up to 30 days for unresolved adverse events; +30 days for serious adverse events
AEs were systematically collected during the study. AEs that were unresolved upon completion or termination from the study were followed for up to 30 calendar days until the event or its sequelae resolved or stabilized. Serious AEs were collected through 30 calendar days after the participant's last study visit.
|
0.17%
1/597 • Through 26-week end-of-study visit or through early termination visit; + up to 30 days for unresolved adverse events; +30 days for serious adverse events
AEs were systematically collected during the study. AEs that were unresolved upon completion or termination from the study were followed for up to 30 calendar days until the event or its sequelae resolved or stabilized. Serious AEs were collected through 30 calendar days after the participant's last study visit.
|
|
Infections and infestations
Bronchitis
|
0.17%
1/601 • Through 26-week end-of-study visit or through early termination visit; + up to 30 days for unresolved adverse events; +30 days for serious adverse events
AEs were systematically collected during the study. AEs that were unresolved upon completion or termination from the study were followed for up to 30 calendar days until the event or its sequelae resolved or stabilized. Serious AEs were collected through 30 calendar days after the participant's last study visit.
|
0.00%
0/597 • Through 26-week end-of-study visit or through early termination visit; + up to 30 days for unresolved adverse events; +30 days for serious adverse events
AEs were systematically collected during the study. AEs that were unresolved upon completion or termination from the study were followed for up to 30 calendar days until the event or its sequelae resolved or stabilized. Serious AEs were collected through 30 calendar days after the participant's last study visit.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/601 • Through 26-week end-of-study visit or through early termination visit; + up to 30 days for unresolved adverse events; +30 days for serious adverse events
AEs were systematically collected during the study. AEs that were unresolved upon completion or termination from the study were followed for up to 30 calendar days until the event or its sequelae resolved or stabilized. Serious AEs were collected through 30 calendar days after the participant's last study visit.
|
0.17%
1/597 • Through 26-week end-of-study visit or through early termination visit; + up to 30 days for unresolved adverse events; +30 days for serious adverse events
AEs were systematically collected during the study. AEs that were unresolved upon completion or termination from the study were followed for up to 30 calendar days until the event or its sequelae resolved or stabilized. Serious AEs were collected through 30 calendar days after the participant's last study visit.
|
|
Infections and infestations
Clostridium Difficile Colitis
|
0.17%
1/601 • Through 26-week end-of-study visit or through early termination visit; + up to 30 days for unresolved adverse events; +30 days for serious adverse events
AEs were systematically collected during the study. AEs that were unresolved upon completion or termination from the study were followed for up to 30 calendar days until the event or its sequelae resolved or stabilized. Serious AEs were collected through 30 calendar days after the participant's last study visit.
|
0.00%
0/597 • Through 26-week end-of-study visit or through early termination visit; + up to 30 days for unresolved adverse events; +30 days for serious adverse events
AEs were systematically collected during the study. AEs that were unresolved upon completion or termination from the study were followed for up to 30 calendar days until the event or its sequelae resolved or stabilized. Serious AEs were collected through 30 calendar days after the participant's last study visit.
|
|
Infections and infestations
Clostridium Difficile Infection
|
0.17%
1/601 • Through 26-week end-of-study visit or through early termination visit; + up to 30 days for unresolved adverse events; +30 days for serious adverse events
AEs were systematically collected during the study. AEs that were unresolved upon completion or termination from the study were followed for up to 30 calendar days until the event or its sequelae resolved or stabilized. Serious AEs were collected through 30 calendar days after the participant's last study visit.
|
0.00%
0/597 • Through 26-week end-of-study visit or through early termination visit; + up to 30 days for unresolved adverse events; +30 days for serious adverse events
AEs were systematically collected during the study. AEs that were unresolved upon completion or termination from the study were followed for up to 30 calendar days until the event or its sequelae resolved or stabilized. Serious AEs were collected through 30 calendar days after the participant's last study visit.
|
|
Infections and infestations
Device Related Infection
|
0.00%
0/601 • Through 26-week end-of-study visit or through early termination visit; + up to 30 days for unresolved adverse events; +30 days for serious adverse events
AEs were systematically collected during the study. AEs that were unresolved upon completion or termination from the study were followed for up to 30 calendar days until the event or its sequelae resolved or stabilized. Serious AEs were collected through 30 calendar days after the participant's last study visit.
|
0.17%
1/597 • Through 26-week end-of-study visit or through early termination visit; + up to 30 days for unresolved adverse events; +30 days for serious adverse events
AEs were systematically collected during the study. AEs that were unresolved upon completion or termination from the study were followed for up to 30 calendar days until the event or its sequelae resolved or stabilized. Serious AEs were collected through 30 calendar days after the participant's last study visit.
|
|
Infections and infestations
Diverticulitis
|
0.17%
1/601 • Through 26-week end-of-study visit or through early termination visit; + up to 30 days for unresolved adverse events; +30 days for serious adverse events
AEs were systematically collected during the study. AEs that were unresolved upon completion or termination from the study were followed for up to 30 calendar days until the event or its sequelae resolved or stabilized. Serious AEs were collected through 30 calendar days after the participant's last study visit.
|
0.00%
0/597 • Through 26-week end-of-study visit or through early termination visit; + up to 30 days for unresolved adverse events; +30 days for serious adverse events
AEs were systematically collected during the study. AEs that were unresolved upon completion or termination from the study were followed for up to 30 calendar days until the event or its sequelae resolved or stabilized. Serious AEs were collected through 30 calendar days after the participant's last study visit.
|
|
Infections and infestations
Localised Infection
|
0.00%
0/601 • Through 26-week end-of-study visit or through early termination visit; + up to 30 days for unresolved adverse events; +30 days for serious adverse events
AEs were systematically collected during the study. AEs that were unresolved upon completion or termination from the study were followed for up to 30 calendar days until the event or its sequelae resolved or stabilized. Serious AEs were collected through 30 calendar days after the participant's last study visit.
|
0.17%
1/597 • Through 26-week end-of-study visit or through early termination visit; + up to 30 days for unresolved adverse events; +30 days for serious adverse events
AEs were systematically collected during the study. AEs that were unresolved upon completion or termination from the study were followed for up to 30 calendar days until the event or its sequelae resolved or stabilized. Serious AEs were collected through 30 calendar days after the participant's last study visit.
|
|
Infections and infestations
Periodontitis
|
0.00%
0/601 • Through 26-week end-of-study visit or through early termination visit; + up to 30 days for unresolved adverse events; +30 days for serious adverse events
AEs were systematically collected during the study. AEs that were unresolved upon completion or termination from the study were followed for up to 30 calendar days until the event or its sequelae resolved or stabilized. Serious AEs were collected through 30 calendar days after the participant's last study visit.
|
0.17%
1/597 • Through 26-week end-of-study visit or through early termination visit; + up to 30 days for unresolved adverse events; +30 days for serious adverse events
AEs were systematically collected during the study. AEs that were unresolved upon completion or termination from the study were followed for up to 30 calendar days until the event or its sequelae resolved or stabilized. Serious AEs were collected through 30 calendar days after the participant's last study visit.
|
|
Infections and infestations
Pneumonia
|
0.17%
1/601 • Through 26-week end-of-study visit or through early termination visit; + up to 30 days for unresolved adverse events; +30 days for serious adverse events
AEs were systematically collected during the study. AEs that were unresolved upon completion or termination from the study were followed for up to 30 calendar days until the event or its sequelae resolved or stabilized. Serious AEs were collected through 30 calendar days after the participant's last study visit.
|
0.17%
1/597 • Through 26-week end-of-study visit or through early termination visit; + up to 30 days for unresolved adverse events; +30 days for serious adverse events
AEs were systematically collected during the study. AEs that were unresolved upon completion or termination from the study were followed for up to 30 calendar days until the event or its sequelae resolved or stabilized. Serious AEs were collected through 30 calendar days after the participant's last study visit.
|
|
Infections and infestations
Post Procedural Infection
|
0.00%
0/601 • Through 26-week end-of-study visit or through early termination visit; + up to 30 days for unresolved adverse events; +30 days for serious adverse events
AEs were systematically collected during the study. AEs that were unresolved upon completion or termination from the study were followed for up to 30 calendar days until the event or its sequelae resolved or stabilized. Serious AEs were collected through 30 calendar days after the participant's last study visit.
|
0.17%
1/597 • Through 26-week end-of-study visit or through early termination visit; + up to 30 days for unresolved adverse events; +30 days for serious adverse events
AEs were systematically collected during the study. AEs that were unresolved upon completion or termination from the study were followed for up to 30 calendar days until the event or its sequelae resolved or stabilized. Serious AEs were collected through 30 calendar days after the participant's last study visit.
|
|
Infections and infestations
Sepsis
|
0.33%
2/601 • Through 26-week end-of-study visit or through early termination visit; + up to 30 days for unresolved adverse events; +30 days for serious adverse events
AEs were systematically collected during the study. AEs that were unresolved upon completion or termination from the study were followed for up to 30 calendar days until the event or its sequelae resolved or stabilized. Serious AEs were collected through 30 calendar days after the participant's last study visit.
|
0.17%
1/597 • Through 26-week end-of-study visit or through early termination visit; + up to 30 days for unresolved adverse events; +30 days for serious adverse events
AEs were systematically collected during the study. AEs that were unresolved upon completion or termination from the study were followed for up to 30 calendar days until the event or its sequelae resolved or stabilized. Serious AEs were collected through 30 calendar days after the participant's last study visit.
|
|
Injury, poisoning and procedural complications
Overdose
|
0.00%
0/601 • Through 26-week end-of-study visit or through early termination visit; + up to 30 days for unresolved adverse events; +30 days for serious adverse events
AEs were systematically collected during the study. AEs that were unresolved upon completion or termination from the study were followed for up to 30 calendar days until the event or its sequelae resolved or stabilized. Serious AEs were collected through 30 calendar days after the participant's last study visit.
|
0.17%
1/597 • Through 26-week end-of-study visit or through early termination visit; + up to 30 days for unresolved adverse events; +30 days for serious adverse events
AEs were systematically collected during the study. AEs that were unresolved upon completion or termination from the study were followed for up to 30 calendar days until the event or its sequelae resolved or stabilized. Serious AEs were collected through 30 calendar days after the participant's last study visit.
|
|
Injury, poisoning and procedural complications
Postoperative Ileus
|
0.00%
0/601 • Through 26-week end-of-study visit or through early termination visit; + up to 30 days for unresolved adverse events; +30 days for serious adverse events
AEs were systematically collected during the study. AEs that were unresolved upon completion or termination from the study were followed for up to 30 calendar days until the event or its sequelae resolved or stabilized. Serious AEs were collected through 30 calendar days after the participant's last study visit.
|
0.17%
1/597 • Through 26-week end-of-study visit or through early termination visit; + up to 30 days for unresolved adverse events; +30 days for serious adverse events
AEs were systematically collected during the study. AEs that were unresolved upon completion or termination from the study were followed for up to 30 calendar days until the event or its sequelae resolved or stabilized. Serious AEs were collected through 30 calendar days after the participant's last study visit.
|
|
Injury, poisoning and procedural complications
Rib Fracture
|
0.17%
1/601 • Through 26-week end-of-study visit or through early termination visit; + up to 30 days for unresolved adverse events; +30 days for serious adverse events
AEs were systematically collected during the study. AEs that were unresolved upon completion or termination from the study were followed for up to 30 calendar days until the event or its sequelae resolved or stabilized. Serious AEs were collected through 30 calendar days after the participant's last study visit.
|
0.00%
0/597 • Through 26-week end-of-study visit or through early termination visit; + up to 30 days for unresolved adverse events; +30 days for serious adverse events
AEs were systematically collected during the study. AEs that were unresolved upon completion or termination from the study were followed for up to 30 calendar days until the event or its sequelae resolved or stabilized. Serious AEs were collected through 30 calendar days after the participant's last study visit.
|
|
Injury, poisoning and procedural complications
Road Traffic Accident
|
0.17%
1/601 • Through 26-week end-of-study visit or through early termination visit; + up to 30 days for unresolved adverse events; +30 days for serious adverse events
AEs were systematically collected during the study. AEs that were unresolved upon completion or termination from the study were followed for up to 30 calendar days until the event or its sequelae resolved or stabilized. Serious AEs were collected through 30 calendar days after the participant's last study visit.
|
0.00%
0/597 • Through 26-week end-of-study visit or through early termination visit; + up to 30 days for unresolved adverse events; +30 days for serious adverse events
AEs were systematically collected during the study. AEs that were unresolved upon completion or termination from the study were followed for up to 30 calendar days until the event or its sequelae resolved or stabilized. Serious AEs were collected through 30 calendar days after the participant's last study visit.
|
|
Injury, poisoning and procedural complications
Sternal Fracture
|
0.17%
1/601 • Through 26-week end-of-study visit or through early termination visit; + up to 30 days for unresolved adverse events; +30 days for serious adverse events
AEs were systematically collected during the study. AEs that were unresolved upon completion or termination from the study were followed for up to 30 calendar days until the event or its sequelae resolved or stabilized. Serious AEs were collected through 30 calendar days after the participant's last study visit.
|
0.00%
0/597 • Through 26-week end-of-study visit or through early termination visit; + up to 30 days for unresolved adverse events; +30 days for serious adverse events
AEs were systematically collected during the study. AEs that were unresolved upon completion or termination from the study were followed for up to 30 calendar days until the event or its sequelae resolved or stabilized. Serious AEs were collected through 30 calendar days after the participant's last study visit.
|
|
Injury, poisoning and procedural complications
Toxicity to Various Agents
|
0.00%
0/601 • Through 26-week end-of-study visit or through early termination visit; + up to 30 days for unresolved adverse events; +30 days for serious adverse events
AEs were systematically collected during the study. AEs that were unresolved upon completion or termination from the study were followed for up to 30 calendar days until the event or its sequelae resolved or stabilized. Serious AEs were collected through 30 calendar days after the participant's last study visit.
|
0.17%
1/597 • Through 26-week end-of-study visit or through early termination visit; + up to 30 days for unresolved adverse events; +30 days for serious adverse events
AEs were systematically collected during the study. AEs that were unresolved upon completion or termination from the study were followed for up to 30 calendar days until the event or its sequelae resolved or stabilized. Serious AEs were collected through 30 calendar days after the participant's last study visit.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/601 • Through 26-week end-of-study visit or through early termination visit; + up to 30 days for unresolved adverse events; +30 days for serious adverse events
AEs were systematically collected during the study. AEs that were unresolved upon completion or termination from the study were followed for up to 30 calendar days until the event or its sequelae resolved or stabilized. Serious AEs were collected through 30 calendar days after the participant's last study visit.
|
0.17%
1/597 • Through 26-week end-of-study visit or through early termination visit; + up to 30 days for unresolved adverse events; +30 days for serious adverse events
AEs were systematically collected during the study. AEs that were unresolved upon completion or termination from the study were followed for up to 30 calendar days until the event or its sequelae resolved or stabilized. Serious AEs were collected through 30 calendar days after the participant's last study visit.
|
|
Metabolism and nutrition disorders
Hypernatraemia
|
0.00%
0/601 • Through 26-week end-of-study visit or through early termination visit; + up to 30 days for unresolved adverse events; +30 days for serious adverse events
AEs were systematically collected during the study. AEs that were unresolved upon completion or termination from the study were followed for up to 30 calendar days until the event or its sequelae resolved or stabilized. Serious AEs were collected through 30 calendar days after the participant's last study visit.
|
0.17%
1/597 • Through 26-week end-of-study visit or through early termination visit; + up to 30 days for unresolved adverse events; +30 days for serious adverse events
AEs were systematically collected during the study. AEs that were unresolved upon completion or termination from the study were followed for up to 30 calendar days until the event or its sequelae resolved or stabilized. Serious AEs were collected through 30 calendar days after the participant's last study visit.
|
|
Metabolism and nutrition disorders
Ketoacidosis
|
0.17%
1/601 • Through 26-week end-of-study visit or through early termination visit; + up to 30 days for unresolved adverse events; +30 days for serious adverse events
AEs were systematically collected during the study. AEs that were unresolved upon completion or termination from the study were followed for up to 30 calendar days until the event or its sequelae resolved or stabilized. Serious AEs were collected through 30 calendar days after the participant's last study visit.
|
0.00%
0/597 • Through 26-week end-of-study visit or through early termination visit; + up to 30 days for unresolved adverse events; +30 days for serious adverse events
AEs were systematically collected during the study. AEs that were unresolved upon completion or termination from the study were followed for up to 30 calendar days until the event or its sequelae resolved or stabilized. Serious AEs were collected through 30 calendar days after the participant's last study visit.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast Cancer
|
0.17%
1/601 • Through 26-week end-of-study visit or through early termination visit; + up to 30 days for unresolved adverse events; +30 days for serious adverse events
AEs were systematically collected during the study. AEs that were unresolved upon completion or termination from the study were followed for up to 30 calendar days until the event or its sequelae resolved or stabilized. Serious AEs were collected through 30 calendar days after the participant's last study visit.
|
0.00%
0/597 • Through 26-week end-of-study visit or through early termination visit; + up to 30 days for unresolved adverse events; +30 days for serious adverse events
AEs were systematically collected during the study. AEs that were unresolved upon completion or termination from the study were followed for up to 30 calendar days until the event or its sequelae resolved or stabilized. Serious AEs were collected through 30 calendar days after the participant's last study visit.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung Neoplasm Malignant
|
0.00%
0/601 • Through 26-week end-of-study visit or through early termination visit; + up to 30 days for unresolved adverse events; +30 days for serious adverse events
AEs were systematically collected during the study. AEs that were unresolved upon completion or termination from the study were followed for up to 30 calendar days until the event or its sequelae resolved or stabilized. Serious AEs were collected through 30 calendar days after the participant's last study visit.
|
0.17%
1/597 • Through 26-week end-of-study visit or through early termination visit; + up to 30 days for unresolved adverse events; +30 days for serious adverse events
AEs were systematically collected during the study. AEs that were unresolved upon completion or termination from the study were followed for up to 30 calendar days until the event or its sequelae resolved or stabilized. Serious AEs were collected through 30 calendar days after the participant's last study visit.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic Carcinoma
|
0.17%
1/601 • Through 26-week end-of-study visit or through early termination visit; + up to 30 days for unresolved adverse events; +30 days for serious adverse events
AEs were systematically collected during the study. AEs that were unresolved upon completion or termination from the study were followed for up to 30 calendar days until the event or its sequelae resolved or stabilized. Serious AEs were collected through 30 calendar days after the participant's last study visit.
|
0.00%
0/597 • Through 26-week end-of-study visit or through early termination visit; + up to 30 days for unresolved adverse events; +30 days for serious adverse events
AEs were systematically collected during the study. AEs that were unresolved upon completion or termination from the study were followed for up to 30 calendar days until the event or its sequelae resolved or stabilized. Serious AEs were collected through 30 calendar days after the participant's last study visit.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Plasma Cell Myeloma
|
0.17%
1/601 • Through 26-week end-of-study visit or through early termination visit; + up to 30 days for unresolved adverse events; +30 days for serious adverse events
AEs were systematically collected during the study. AEs that were unresolved upon completion or termination from the study were followed for up to 30 calendar days until the event or its sequelae resolved or stabilized. Serious AEs were collected through 30 calendar days after the participant's last study visit.
|
0.00%
0/597 • Through 26-week end-of-study visit or through early termination visit; + up to 30 days for unresolved adverse events; +30 days for serious adverse events
AEs were systematically collected during the study. AEs that were unresolved upon completion or termination from the study were followed for up to 30 calendar days until the event or its sequelae resolved or stabilized. Serious AEs were collected through 30 calendar days after the participant's last study visit.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal Cell Carcinoma
|
0.00%
0/601 • Through 26-week end-of-study visit or through early termination visit; + up to 30 days for unresolved adverse events; +30 days for serious adverse events
AEs were systematically collected during the study. AEs that were unresolved upon completion or termination from the study were followed for up to 30 calendar days until the event or its sequelae resolved or stabilized. Serious AEs were collected through 30 calendar days after the participant's last study visit.
|
0.17%
1/597 • Through 26-week end-of-study visit or through early termination visit; + up to 30 days for unresolved adverse events; +30 days for serious adverse events
AEs were systematically collected during the study. AEs that were unresolved upon completion or termination from the study were followed for up to 30 calendar days until the event or its sequelae resolved or stabilized. Serious AEs were collected through 30 calendar days after the participant's last study visit.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/601 • Through 26-week end-of-study visit or through early termination visit; + up to 30 days for unresolved adverse events; +30 days for serious adverse events
AEs were systematically collected during the study. AEs that were unresolved upon completion or termination from the study were followed for up to 30 calendar days until the event or its sequelae resolved or stabilized. Serious AEs were collected through 30 calendar days after the participant's last study visit.
|
0.17%
1/597 • Through 26-week end-of-study visit or through early termination visit; + up to 30 days for unresolved adverse events; +30 days for serious adverse events
AEs were systematically collected during the study. AEs that were unresolved upon completion or termination from the study were followed for up to 30 calendar days until the event or its sequelae resolved or stabilized. Serious AEs were collected through 30 calendar days after the participant's last study visit.
|
|
Nervous system disorders
Transient Ischaemic Attack
|
0.00%
0/601 • Through 26-week end-of-study visit or through early termination visit; + up to 30 days for unresolved adverse events; +30 days for serious adverse events
AEs were systematically collected during the study. AEs that were unresolved upon completion or termination from the study were followed for up to 30 calendar days until the event or its sequelae resolved or stabilized. Serious AEs were collected through 30 calendar days after the participant's last study visit.
|
0.17%
1/597 • Through 26-week end-of-study visit or through early termination visit; + up to 30 days for unresolved adverse events; +30 days for serious adverse events
AEs were systematically collected during the study. AEs that were unresolved upon completion or termination from the study were followed for up to 30 calendar days until the event or its sequelae resolved or stabilized. Serious AEs were collected through 30 calendar days after the participant's last study visit.
|
|
Psychiatric disorders
Bipolar Disorder
|
0.17%
1/601 • Through 26-week end-of-study visit or through early termination visit; + up to 30 days for unresolved adverse events; +30 days for serious adverse events
AEs were systematically collected during the study. AEs that were unresolved upon completion or termination from the study were followed for up to 30 calendar days until the event or its sequelae resolved or stabilized. Serious AEs were collected through 30 calendar days after the participant's last study visit.
|
0.00%
0/597 • Through 26-week end-of-study visit or through early termination visit; + up to 30 days for unresolved adverse events; +30 days for serious adverse events
AEs were systematically collected during the study. AEs that were unresolved upon completion or termination from the study were followed for up to 30 calendar days until the event or its sequelae resolved or stabilized. Serious AEs were collected through 30 calendar days after the participant's last study visit.
|
|
Psychiatric disorders
Depression
|
0.17%
1/601 • Through 26-week end-of-study visit or through early termination visit; + up to 30 days for unresolved adverse events; +30 days for serious adverse events
AEs were systematically collected during the study. AEs that were unresolved upon completion or termination from the study were followed for up to 30 calendar days until the event or its sequelae resolved or stabilized. Serious AEs were collected through 30 calendar days after the participant's last study visit.
|
0.00%
0/597 • Through 26-week end-of-study visit or through early termination visit; + up to 30 days for unresolved adverse events; +30 days for serious adverse events
AEs were systematically collected during the study. AEs that were unresolved upon completion or termination from the study were followed for up to 30 calendar days until the event or its sequelae resolved or stabilized. Serious AEs were collected through 30 calendar days after the participant's last study visit.
|
|
Psychiatric disorders
Substance Abuse
|
0.00%
0/601 • Through 26-week end-of-study visit or through early termination visit; + up to 30 days for unresolved adverse events; +30 days for serious adverse events
AEs were systematically collected during the study. AEs that were unresolved upon completion or termination from the study were followed for up to 30 calendar days until the event or its sequelae resolved or stabilized. Serious AEs were collected through 30 calendar days after the participant's last study visit.
|
0.17%
1/597 • Through 26-week end-of-study visit or through early termination visit; + up to 30 days for unresolved adverse events; +30 days for serious adverse events
AEs were systematically collected during the study. AEs that were unresolved upon completion or termination from the study were followed for up to 30 calendar days until the event or its sequelae resolved or stabilized. Serious AEs were collected through 30 calendar days after the participant's last study visit.
|
|
Psychiatric disorders
Suicidal Ideation
|
0.17%
1/601 • Through 26-week end-of-study visit or through early termination visit; + up to 30 days for unresolved adverse events; +30 days for serious adverse events
AEs were systematically collected during the study. AEs that were unresolved upon completion or termination from the study were followed for up to 30 calendar days until the event or its sequelae resolved or stabilized. Serious AEs were collected through 30 calendar days after the participant's last study visit.
|
0.00%
0/597 • Through 26-week end-of-study visit or through early termination visit; + up to 30 days for unresolved adverse events; +30 days for serious adverse events
AEs were systematically collected during the study. AEs that were unresolved upon completion or termination from the study were followed for up to 30 calendar days until the event or its sequelae resolved or stabilized. Serious AEs were collected through 30 calendar days after the participant's last study visit.
|
|
Renal and urinary disorders
Acute Kidney Injury
|
0.00%
0/601 • Through 26-week end-of-study visit or through early termination visit; + up to 30 days for unresolved adverse events; +30 days for serious adverse events
AEs were systematically collected during the study. AEs that were unresolved upon completion or termination from the study were followed for up to 30 calendar days until the event or its sequelae resolved or stabilized. Serious AEs were collected through 30 calendar days after the participant's last study visit.
|
0.34%
2/597 • Through 26-week end-of-study visit or through early termination visit; + up to 30 days for unresolved adverse events; +30 days for serious adverse events
AEs were systematically collected during the study. AEs that were unresolved upon completion or termination from the study were followed for up to 30 calendar days until the event or its sequelae resolved or stabilized. Serious AEs were collected through 30 calendar days after the participant's last study visit.
|
|
Renal and urinary disorders
Renal Injury
|
0.17%
1/601 • Through 26-week end-of-study visit or through early termination visit; + up to 30 days for unresolved adverse events; +30 days for serious adverse events
AEs were systematically collected during the study. AEs that were unresolved upon completion or termination from the study were followed for up to 30 calendar days until the event or its sequelae resolved or stabilized. Serious AEs were collected through 30 calendar days after the participant's last study visit.
|
0.00%
0/597 • Through 26-week end-of-study visit or through early termination visit; + up to 30 days for unresolved adverse events; +30 days for serious adverse events
AEs were systematically collected during the study. AEs that were unresolved upon completion or termination from the study were followed for up to 30 calendar days until the event or its sequelae resolved or stabilized. Serious AEs were collected through 30 calendar days after the participant's last study visit.
|
|
Reproductive system and breast disorders
Menorrhagia
|
0.00%
0/601 • Through 26-week end-of-study visit or through early termination visit; + up to 30 days for unresolved adverse events; +30 days for serious adverse events
AEs were systematically collected during the study. AEs that were unresolved upon completion or termination from the study were followed for up to 30 calendar days until the event or its sequelae resolved or stabilized. Serious AEs were collected through 30 calendar days after the participant's last study visit.
|
0.17%
1/597 • Through 26-week end-of-study visit or through early termination visit; + up to 30 days for unresolved adverse events; +30 days for serious adverse events
AEs were systematically collected during the study. AEs that were unresolved upon completion or termination from the study were followed for up to 30 calendar days until the event or its sequelae resolved or stabilized. Serious AEs were collected through 30 calendar days after the participant's last study visit.
|
|
Respiratory, thoracic and mediastinal disorders
Acute Respiratory Failure
|
0.17%
1/601 • Through 26-week end-of-study visit or through early termination visit; + up to 30 days for unresolved adverse events; +30 days for serious adverse events
AEs were systematically collected during the study. AEs that were unresolved upon completion or termination from the study were followed for up to 30 calendar days until the event or its sequelae resolved or stabilized. Serious AEs were collected through 30 calendar days after the participant's last study visit.
|
0.00%
0/597 • Through 26-week end-of-study visit or through early termination visit; + up to 30 days for unresolved adverse events; +30 days for serious adverse events
AEs were systematically collected during the study. AEs that were unresolved upon completion or termination from the study were followed for up to 30 calendar days until the event or its sequelae resolved or stabilized. Serious AEs were collected through 30 calendar days after the participant's last study visit.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic Obstructive Pulmonary Disease
|
0.00%
0/601 • Through 26-week end-of-study visit or through early termination visit; + up to 30 days for unresolved adverse events; +30 days for serious adverse events
AEs were systematically collected during the study. AEs that were unresolved upon completion or termination from the study were followed for up to 30 calendar days until the event or its sequelae resolved or stabilized. Serious AEs were collected through 30 calendar days after the participant's last study visit.
|
0.17%
1/597 • Through 26-week end-of-study visit or through early termination visit; + up to 30 days for unresolved adverse events; +30 days for serious adverse events
AEs were systematically collected during the study. AEs that were unresolved upon completion or termination from the study were followed for up to 30 calendar days until the event or its sequelae resolved or stabilized. Serious AEs were collected through 30 calendar days after the participant's last study visit.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.17%
1/601 • Through 26-week end-of-study visit or through early termination visit; + up to 30 days for unresolved adverse events; +30 days for serious adverse events
AEs were systematically collected during the study. AEs that were unresolved upon completion or termination from the study were followed for up to 30 calendar days until the event or its sequelae resolved or stabilized. Serious AEs were collected through 30 calendar days after the participant's last study visit.
|
0.00%
0/597 • Through 26-week end-of-study visit or through early termination visit; + up to 30 days for unresolved adverse events; +30 days for serious adverse events
AEs were systematically collected during the study. AEs that were unresolved upon completion or termination from the study were followed for up to 30 calendar days until the event or its sequelae resolved or stabilized. Serious AEs were collected through 30 calendar days after the participant's last study visit.
|
|
Skin and subcutaneous tissue disorders
Diabetic Foot
|
0.00%
0/601 • Through 26-week end-of-study visit or through early termination visit; + up to 30 days for unresolved adverse events; +30 days for serious adverse events
AEs were systematically collected during the study. AEs that were unresolved upon completion or termination from the study were followed for up to 30 calendar days until the event or its sequelae resolved or stabilized. Serious AEs were collected through 30 calendar days after the participant's last study visit.
|
0.17%
1/597 • Through 26-week end-of-study visit or through early termination visit; + up to 30 days for unresolved adverse events; +30 days for serious adverse events
AEs were systematically collected during the study. AEs that were unresolved upon completion or termination from the study were followed for up to 30 calendar days until the event or its sequelae resolved or stabilized. Serious AEs were collected through 30 calendar days after the participant's last study visit.
|
|
Vascular disorders
Peripheral Arterial Occlusive Disease
|
0.17%
1/601 • Through 26-week end-of-study visit or through early termination visit; + up to 30 days for unresolved adverse events; +30 days for serious adverse events
AEs were systematically collected during the study. AEs that were unresolved upon completion or termination from the study were followed for up to 30 calendar days until the event or its sequelae resolved or stabilized. Serious AEs were collected through 30 calendar days after the participant's last study visit.
|
0.00%
0/597 • Through 26-week end-of-study visit or through early termination visit; + up to 30 days for unresolved adverse events; +30 days for serious adverse events
AEs were systematically collected during the study. AEs that were unresolved upon completion or termination from the study were followed for up to 30 calendar days until the event or its sequelae resolved or stabilized. Serious AEs were collected through 30 calendar days after the participant's last study visit.
|
Other adverse events
| Measure |
Placebo
n=601 participants at risk
Placebo capsaicin mouth spray, 0 mg nicotine/dose, intraorally per label directions
|
Nicotine
n=597 participants at risk
Nicotine mouth spray, 1 mg nicotine/dose, intraorally per label directions
|
|---|---|---|
|
Gastrointestinal disorders
Nausea
|
4.3%
26/601 • Through 26-week end-of-study visit or through early termination visit; + up to 30 days for unresolved adverse events; +30 days for serious adverse events
AEs were systematically collected during the study. AEs that were unresolved upon completion or termination from the study were followed for up to 30 calendar days until the event or its sequelae resolved or stabilized. Serious AEs were collected through 30 calendar days after the participant's last study visit.
|
9.9%
59/597 • Through 26-week end-of-study visit or through early termination visit; + up to 30 days for unresolved adverse events; +30 days for serious adverse events
AEs were systematically collected during the study. AEs that were unresolved upon completion or termination from the study were followed for up to 30 calendar days until the event or its sequelae resolved or stabilized. Serious AEs were collected through 30 calendar days after the participant's last study visit.
|
|
Infections and infestations
Nasopharyngitis
|
3.7%
22/601 • Through 26-week end-of-study visit or through early termination visit; + up to 30 days for unresolved adverse events; +30 days for serious adverse events
AEs were systematically collected during the study. AEs that were unresolved upon completion or termination from the study were followed for up to 30 calendar days until the event or its sequelae resolved or stabilized. Serious AEs were collected through 30 calendar days after the participant's last study visit.
|
5.9%
35/597 • Through 26-week end-of-study visit or through early termination visit; + up to 30 days for unresolved adverse events; +30 days for serious adverse events
AEs were systematically collected during the study. AEs that were unresolved upon completion or termination from the study were followed for up to 30 calendar days until the event or its sequelae resolved or stabilized. Serious AEs were collected through 30 calendar days after the participant's last study visit.
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
3.8%
23/601 • Through 26-week end-of-study visit or through early termination visit; + up to 30 days for unresolved adverse events; +30 days for serious adverse events
AEs were systematically collected during the study. AEs that were unresolved upon completion or termination from the study were followed for up to 30 calendar days until the event or its sequelae resolved or stabilized. Serious AEs were collected through 30 calendar days after the participant's last study visit.
|
5.9%
35/597 • Through 26-week end-of-study visit or through early termination visit; + up to 30 days for unresolved adverse events; +30 days for serious adverse events
AEs were systematically collected during the study. AEs that were unresolved upon completion or termination from the study were followed for up to 30 calendar days until the event or its sequelae resolved or stabilized. Serious AEs were collected through 30 calendar days after the participant's last study visit.
|
|
Nervous system disorders
Headache
|
6.3%
38/601 • Through 26-week end-of-study visit or through early termination visit; + up to 30 days for unresolved adverse events; +30 days for serious adverse events
AEs were systematically collected during the study. AEs that were unresolved upon completion or termination from the study were followed for up to 30 calendar days until the event or its sequelae resolved or stabilized. Serious AEs were collected through 30 calendar days after the participant's last study visit.
|
8.0%
48/597 • Through 26-week end-of-study visit or through early termination visit; + up to 30 days for unresolved adverse events; +30 days for serious adverse events
AEs were systematically collected during the study. AEs that were unresolved upon completion or termination from the study were followed for up to 30 calendar days until the event or its sequelae resolved or stabilized. Serious AEs were collected through 30 calendar days after the participant's last study visit.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
7.8%
47/601 • Through 26-week end-of-study visit or through early termination visit; + up to 30 days for unresolved adverse events; +30 days for serious adverse events
AEs were systematically collected during the study. AEs that were unresolved upon completion or termination from the study were followed for up to 30 calendar days until the event or its sequelae resolved or stabilized. Serious AEs were collected through 30 calendar days after the participant's last study visit.
|
42.2%
252/597 • Through 26-week end-of-study visit or through early termination visit; + up to 30 days for unresolved adverse events; +30 days for serious adverse events
AEs were systematically collected during the study. AEs that were unresolved upon completion or termination from the study were followed for up to 30 calendar days until the event or its sequelae resolved or stabilized. Serious AEs were collected through 30 calendar days after the participant's last study visit.
|
|
Vascular disorders
Hypertension
|
3.0%
18/601 • Through 26-week end-of-study visit or through early termination visit; + up to 30 days for unresolved adverse events; +30 days for serious adverse events
AEs were systematically collected during the study. AEs that were unresolved upon completion or termination from the study were followed for up to 30 calendar days until the event or its sequelae resolved or stabilized. Serious AEs were collected through 30 calendar days after the participant's last study visit.
|
5.0%
30/597 • Through 26-week end-of-study visit or through early termination visit; + up to 30 days for unresolved adverse events; +30 days for serious adverse events
AEs were systematically collected during the study. AEs that were unresolved upon completion or termination from the study were followed for up to 30 calendar days until the event or its sequelae resolved or stabilized. Serious AEs were collected through 30 calendar days after the participant's last study visit.
|
Additional Information
Andrew Myers, MD, Director, Clinical Research
JNJWorldwide
Phone: (215) 273-8421 USA EST
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Prior to submission for publication, PI was to provide sponsor with ≥ 60 days for publication review. No publication that included sponsor confidential information was to be submitted without sponsor's consent. If requested, the PI was to withhold publication for up to 60 additional days to allow for patent application filing. First publication of study results was to be a joint, multicenter publication; if not submitted within 6 months after end of study, the PI may publish the site results.
- Publication restrictions are in place
Restriction type: OTHER