Trial Outcomes & Findings for Efficacy and Safety Study of Nicotine Mint Lozenge (2mg and 4mg) in Smoking Cessation (NCT NCT00985985)
NCT ID: NCT00985985
Last Updated: 2014-06-27
Results Overview
Rate of Successful Smoking Cessation at Week 6 was measured by Carbon Monoxide (CO) breath levels.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
723 participants
Primary outcome timeframe
From baseline to Week 6
Results posted on
2014-06-27
Participant Flow
Participants were recruited at the clinical site.
Of 781 screened participants, only 723 were randomized and remaining 58 were considered screening failures. Participants who smoked their first cigarette within 30 minutes after waking were considered as high dependence smokers while those who smoked their first cigarette after 30 minutes of waking were considered as low dependence smokers.
Participant milestones
| Measure |
Nicotine Lozenge 2 Milligram (mg) (Low Dependence Smokers)
Participants who smoked their first cigarette after 30 minutes of waking received 2 mg of nicotine lozenge, orally. During week 1 to week 6,participants were recommended to take at least 9 lozenges per day, but not exceeding 15 lozenges. During week 7 to week 9, participants were recommended to use 12 to 6 lozenges per day, further taking 3 to 6 lozenges only by week 10 to 12. Afterwards, lozenge was taken when necessary to prevent relapse.
|
Placebo Lozenge (Low Dependence Smokers)
Participants who smoked their first cigarette after 30 minutes of waking received placebo lozenge containing 0 mg of nicotine, orally. During week 1 to week 6, participants were recommended to take atleast 9 lozenges per day but not exceeding 15 lozenges. During week 7 to week 9, participants were recommended to use 12 to 6 lozenges per day, further taking 3 to 6 lozenges only by week 10 to 12. Afterwards, lozenge was taken when necessary to prevent relapse
|
Nicotine Lozenge 4 mg (High Dependence Smokers)
Participants who smoked their first cigarette within 30 minutes after waking received 4 mg nicotine lozenge, orally. During week 1 to week 6, participants were recommended to take at least 9 lozenges per day but not exceeding 15 lozenges. During week 7 to week 9, participants were recommended to use 12 to 6 lozenge per day, further taking 3 to 6 lozenges only by week 10 to 12. Afterwards, lozenge was taken when necessary to prevent relapse.
|
Placebo Lozenge (High Dependence Smoke
Participants who smoked their first cigarette within 30 minutes after waking received placebo lozenge containing 0 mg of nicotine, orally. During week 1 to week 6, participants were recommended to take at least 9 lozenges per day but not exceeding 15 lozenges. During week 7 to week 9, participants were recommended to use 12 to 6 lozenge per day, further taking 3 to 6 lozenges only by week 10 to 12. Afterwards, lozenge was taken when necessary to prevent relapse.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
241
|
242
|
120
|
120
|
|
Overall Study
Safety Population
|
241
|
242
|
119
|
118
|
|
Overall Study
Full Analysis Set (FAS) Population
|
241
|
242
|
120
|
119
|
|
Overall Study
COMPLETED
|
217
|
218
|
109
|
107
|
|
Overall Study
NOT COMPLETED
|
24
|
24
|
11
|
13
|
Reasons for withdrawal
| Measure |
Nicotine Lozenge 2 Milligram (mg) (Low Dependence Smokers)
Participants who smoked their first cigarette after 30 minutes of waking received 2 mg of nicotine lozenge, orally. During week 1 to week 6,participants were recommended to take at least 9 lozenges per day, but not exceeding 15 lozenges. During week 7 to week 9, participants were recommended to use 12 to 6 lozenges per day, further taking 3 to 6 lozenges only by week 10 to 12. Afterwards, lozenge was taken when necessary to prevent relapse.
|
Placebo Lozenge (Low Dependence Smokers)
Participants who smoked their first cigarette after 30 minutes of waking received placebo lozenge containing 0 mg of nicotine, orally. During week 1 to week 6, participants were recommended to take atleast 9 lozenges per day but not exceeding 15 lozenges. During week 7 to week 9, participants were recommended to use 12 to 6 lozenges per day, further taking 3 to 6 lozenges only by week 10 to 12. Afterwards, lozenge was taken when necessary to prevent relapse
|
Nicotine Lozenge 4 mg (High Dependence Smokers)
Participants who smoked their first cigarette within 30 minutes after waking received 4 mg nicotine lozenge, orally. During week 1 to week 6, participants were recommended to take at least 9 lozenges per day but not exceeding 15 lozenges. During week 7 to week 9, participants were recommended to use 12 to 6 lozenge per day, further taking 3 to 6 lozenges only by week 10 to 12. Afterwards, lozenge was taken when necessary to prevent relapse.
|
Placebo Lozenge (High Dependence Smoke
Participants who smoked their first cigarette within 30 minutes after waking received placebo lozenge containing 0 mg of nicotine, orally. During week 1 to week 6, participants were recommended to take at least 9 lozenges per day but not exceeding 15 lozenges. During week 7 to week 9, participants were recommended to use 12 to 6 lozenge per day, further taking 3 to 6 lozenges only by week 10 to 12. Afterwards, lozenge was taken when necessary to prevent relapse.
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
4
|
2
|
2
|
2
|
|
Overall Study
Lost to Follow-up
|
4
|
11
|
2
|
3
|
|
Overall Study
Protocol Violation
|
1
|
2
|
0
|
1
|
|
Overall Study
Lack of Efficacy
|
5
|
6
|
1
|
3
|
|
Overall Study
Withdrawal by Subject
|
4
|
2
|
2
|
2
|
|
Overall Study
Other Reason
|
6
|
1
|
4
|
2
|
Baseline Characteristics
Efficacy and Safety Study of Nicotine Mint Lozenge (2mg and 4mg) in Smoking Cessation
Baseline characteristics by cohort
| Measure |
Nicotine Lozenge 2 mg (Low Dependence Smokers)
n=241 Participants
Participants who smoked their first cigarette after 30 minutes of waking received 2 mg of nicotine lozenge, orally.
|
Placebo Lozenge (Low Dependence Smokers)
n=242 Participants
Participants who smoked their first cigarette after 30 minutes of waking received placebo lozenge containing 0 mg of nicotine, orally.
|
Nicotine Lozenge 4 mg (High Dependence Smokers)
n=120 Participants
Participants who smoked their first cigarette within 30 minutes after waking received 4 mg nicotine lozenge, orally.
|
Placebo Lozenge (High Dependence Smokers)
n=119 Participants
Participants who smoked their first cigarette within 30 minutes after waking received placebo lozenge containing 0 mg of nicotine, orally.
|
Total
n=722 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
38.4 Years
STANDARD_DEVIATION 11.78 • n=5 Participants
|
39.9 Years
STANDARD_DEVIATION 11.76 • n=7 Participants
|
42.3 Years
STANDARD_DEVIATION 10.38 • n=5 Participants
|
42.0 Years
STANDARD_DEVIATION 10.57 • n=4 Participants
|
40.1 Years
STANDARD_DEVIATION 11.44 • n=21 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
23 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
230 Participants
n=5 Participants
|
235 Participants
n=7 Participants
|
118 Participants
n=5 Participants
|
116 Participants
n=4 Participants
|
699 Participants
n=21 Participants
|
|
Body Weight
|
71.8 Kg
STANDARD_DEVIATION 11.06 • n=5 Participants
|
72.3 Kg
STANDARD_DEVIATION 11.42 • n=7 Participants
|
75.9 Kg
STANDARD_DEVIATION 11.64 • n=5 Participants
|
74.3 Kg
STANDARD_DEVIATION 12.15 • n=4 Participants
|
73.1 Kg
STANDARD_DEVIATION 11.53 • n=21 Participants
|
PRIMARY outcome
Timeframe: From baseline to Week 6Population: Analysis was considered per Full Analysis Set (FAS) population. FAS population consisted of all randomized participants who had study medication for at least once with assessment data post-dosing.
Rate of Successful Smoking Cessation at Week 6 was measured by Carbon Monoxide (CO) breath levels.
Outcome measures
| Measure |
Nicotine Lozenge 2 mg (Low Dependence Smokers)
n=241 Participants
Participants, who smoked their first cigarette after 30 minutes of waking, received 2 mg of nicotine lozenge orally.
|
Placebo Lozenge (Low Dependence Smokers)
n=242 Participants
Participants, who smoked their first cigarette after 30 minutes of waking, received placebo lozenge containing 0 mg of nicotine orally.
|
Nicotine Lozenge 4 mg (High Dependence Smokers)
n=120 Participants
Participants, who smoked their first cigarette within 30 minutes after waking, received 4 mg nicotine lozenge orally.
|
Placebo Lozenge (High Dependence Smokers)
n=119 Participants
Participants, who smoked their first cigarette within 30 minutes after waking, received placebo lozenge containing 0 mg of nicotine orally.
|
|---|---|---|---|---|
|
Rate of Successful Smoking Cessation at Week 6
|
24.48 Percentage of participants
|
21.49 Percentage of participants
|
30.83 Percentage of participants
|
20.17 Percentage of participants
|
SECONDARY outcome
Timeframe: From baseline to Week 12 and Week 24Population: Analysis was done per FAS population. FAS population consisted of all randomized subjects who had study medication for at least once with assessment data post-dosing.
Continuous abstinence was verified by measurement of CO breath levels.
Outcome measures
| Measure |
Nicotine Lozenge 2 mg (Low Dependence Smokers)
n=241 Participants
Participants, who smoked their first cigarette after 30 minutes of waking, received 2 mg of nicotine lozenge orally.
|
Placebo Lozenge (Low Dependence Smokers)
n=242 Participants
Participants, who smoked their first cigarette after 30 minutes of waking, received placebo lozenge containing 0 mg of nicotine orally.
|
Nicotine Lozenge 4 mg (High Dependence Smokers)
n=120 Participants
Participants, who smoked their first cigarette within 30 minutes after waking, received 4 mg nicotine lozenge orally.
|
Placebo Lozenge (High Dependence Smokers)
n=119 Participants
Participants, who smoked their first cigarette within 30 minutes after waking, received placebo lozenge containing 0 mg of nicotine orally.
|
|---|---|---|---|---|
|
Rate of Continuous Successful Smoking Cessation at Week 12 and Week 24
Smoking Cessation Rate at 12 weeks
|
17.84 Percentage of participants
|
16.94 Percentage of participants
|
22.50 Percentage of participants
|
10.92 Percentage of participants
|
|
Rate of Continuous Successful Smoking Cessation at Week 12 and Week 24
Smoking Cessation Rate at 24 weeks
|
12.86 Percentage of participants
|
13.22 Percentage of participants
|
19.17 Percentage of participants
|
10.08 Percentage of participants
|
SECONDARY outcome
Timeframe: From Week 6 to Week 24Population: Analysis was done per FAS population. FAS population consisted of all randomized subjects who had study medication for at least once with assessment data post-dosing.
Rate of long-term successful smoking cessation at Week 24 was defined as the proportion of participants who achieved the primary end-point with no more than six cumulative days of smoking from Week 6 to Week 24.
Outcome measures
| Measure |
Nicotine Lozenge 2 mg (Low Dependence Smokers)
n=241 Participants
Participants, who smoked their first cigarette after 30 minutes of waking, received 2 mg of nicotine lozenge orally.
|
Placebo Lozenge (Low Dependence Smokers)
n=242 Participants
Participants, who smoked their first cigarette after 30 minutes of waking, received placebo lozenge containing 0 mg of nicotine orally.
|
Nicotine Lozenge 4 mg (High Dependence Smokers)
n=120 Participants
Participants, who smoked their first cigarette within 30 minutes after waking, received 4 mg nicotine lozenge orally.
|
Placebo Lozenge (High Dependence Smokers)
n=119 Participants
Participants, who smoked their first cigarette within 30 minutes after waking, received placebo lozenge containing 0 mg of nicotine orally.
|
|---|---|---|---|---|
|
Rate of Long-term Successful Smoking Cessation at Week 24
|
19.09 Percentage of participants
|
17.77 Percentage of participants
|
24.17 Percentage of participants
|
15.97 Percentage of participants
|
SECONDARY outcome
Timeframe: Weekly assessment at Week 1, 2, 4, 6, 12 and Week 24Population: Analysis was carried out per FAS population. FAS population consisted of all randomized subjects who had study medication for at least once with assessment data post-dosing.
Seven day point prevalence abstinence was defined as complete abstinence from smoking for the 7 days up to and including the evaluation day.
Outcome measures
| Measure |
Nicotine Lozenge 2 mg (Low Dependence Smokers)
n=241 Participants
Participants, who smoked their first cigarette after 30 minutes of waking, received 2 mg of nicotine lozenge orally.
|
Placebo Lozenge (Low Dependence Smokers)
n=242 Participants
Participants, who smoked their first cigarette after 30 minutes of waking, received placebo lozenge containing 0 mg of nicotine orally.
|
Nicotine Lozenge 4 mg (High Dependence Smokers)
n=120 Participants
Participants, who smoked their first cigarette within 30 minutes after waking, received 4 mg nicotine lozenge orally.
|
Placebo Lozenge (High Dependence Smokers)
n=119 Participants
Participants, who smoked their first cigarette within 30 minutes after waking, received placebo lozenge containing 0 mg of nicotine orally.
|
|---|---|---|---|---|
|
Proportion of Participants With Seven Day Point Prevalence Abstinence
Week 1
|
12.45 Percentage of participants
|
11.98 Percentage of participants
|
20.00 Percentage of participants
|
10.08 Percentage of participants
|
|
Proportion of Participants With Seven Day Point Prevalence Abstinence
Week 2
|
21.16 Percentage of participants
|
23.14 Percentage of participants
|
33.33 Percentage of participants
|
26.05 Percentage of participants
|
|
Proportion of Participants With Seven Day Point Prevalence Abstinence
Week 4
|
31.95 Percentage of participants
|
29.34 Percentage of participants
|
36.67 Percentage of participants
|
30.25 Percentage of participants
|
|
Proportion of Participants With Seven Day Point Prevalence Abstinence
Week 6
|
35.68 Percentage of participants
|
37.19 Percentage of participants
|
41.67 Percentage of participants
|
32.77 Percentage of participants
|
|
Proportion of Participants With Seven Day Point Prevalence Abstinence
Week 12
|
41.49 Percentage of participants
|
39.26 Percentage of participants
|
40.83 Percentage of participants
|
26.05 Percentage of participants
|
|
Proportion of Participants With Seven Day Point Prevalence Abstinence
Week 24
|
41.49 Percentage of participants
|
43.80 Percentage of participants
|
50.00 Percentage of participants
|
43.70 Percentage of participants
|
SECONDARY outcome
Timeframe: Weekly assessment at Week 1, 2, 3, 4, 5 and Week 6Population: Analysis was carried out per FAS population, which consisted of all randomized subjects who have had study medication for at least once with assessment data post-dosing. Due to drop outs, there was difference in the number of participants analyzed (n) for this outcome measure. Missing values were not imputed.
The evaluation of withdrawal and craving symptoms was carried out every day with the Minnesota Nicotine Withdrawal scale (MNWS). The MNWS total score contains 9 items (urge to smoke; depressed mood; irritability, frustration, or anger; anxiety; difficulty concentrating; restlessness; increased appetite; difficulty going to sleep; difficulty staying asleep). Each item was rated on a 5 grade scale with scores ranging from 0 (best score) to 4 (worst score) i.e. none (score=0), slight (score=1), mild (score=2), moderate (score=3), and severe (score=4). For each symptom at each week, the average score was calculated as the average of the daily scores during that week. The total score was calculated as the sum of the 9 symptoms.
Outcome measures
| Measure |
Nicotine Lozenge 2 mg (Low Dependence Smokers)
n=236 Participants
Participants, who smoked their first cigarette after 30 minutes of waking, received 2 mg of nicotine lozenge orally.
|
Placebo Lozenge (Low Dependence Smokers)
n=238 Participants
Participants, who smoked their first cigarette after 30 minutes of waking, received placebo lozenge containing 0 mg of nicotine orally.
|
Nicotine Lozenge 4 mg (High Dependence Smokers)
n=119 Participants
Participants, who smoked their first cigarette within 30 minutes after waking, received 4 mg nicotine lozenge orally.
|
Placebo Lozenge (High Dependence Smokers)
n=118 Participants
Participants, who smoked their first cigarette within 30 minutes after waking, received placebo lozenge containing 0 mg of nicotine orally.
|
|---|---|---|---|---|
|
Mean Score of Relief of Craving/ Total Withdrawal Symptoms
Week 1 (n=236, 238, 119, 118)
|
8.40 Score on a scale
Standard Deviation 7.18
|
7.77 Score on a scale
Standard Deviation 6.55
|
7.66 Score on a scale
Standard Deviation 6.08
|
8.67 Score on a scale
Standard Deviation 7.02
|
|
Mean Score of Relief of Craving/ Total Withdrawal Symptoms
Week 2 (n=230, 233, 112, 115)
|
7.59 Score on a scale
Standard Deviation 7.25
|
6.84 Score on a scale
Standard Deviation 6.05
|
6.70 Score on a scale
Standard Deviation 5.96
|
7.39 Score on a scale
Standard Deviation 6.12
|
|
Mean Score of Relief of Craving/ Total Withdrawal Symptoms
Week 3 (n=226, 232, 115, 110)
|
6.80 Score on a scale
Standard Deviation 7.12
|
6.06 Score on a scale
Standard Deviation 5.83
|
6.17 Score on a scale
Standard Deviation 6.40
|
6.90 Score on a scale
Standard Deviation 5.97
|
|
Mean Score of Relief of Craving/ Total Withdrawal Symptoms
Week 4 (n=225, 226, 113, 108)
|
6.67 Score on a scale
Standard Deviation 7.36
|
5.45 Score on a scale
Standard Deviation 5.59
|
5.66 Score on a scale
Standard Deviation 6.19
|
6.71 Score on a scale
Standard Deviation 6.06
|
|
Mean Score of Relief of Craving/ Total Withdrawal Symptoms
Week 5 (n=221, 229, 112, 104)
|
6.06 Score on a scale
Standard Deviation 6.57
|
5.29 Score on a scale
Standard Deviation 5.72
|
5.60 Score on a scale
Standard Deviation 5.98
|
6.60 Score on a scale
Standard Deviation 5.94
|
|
Mean Score of Relief of Craving/ Total Withdrawal Symptoms
Week 6 (215, 223, 103, 102)
|
5.85 Score on a scale
Standard Deviation 6.53
|
5.45 Score on a scale
Standard Deviation 6.02
|
5.21 Score on a scale
Standard Deviation 5.58
|
6.49 Score on a scale
Standard Deviation 6.23
|
SECONDARY outcome
Timeframe: Weeks 1-2, 3-4, 5-6, 7-12 and 13-24Population: Analysis was carried out per FAS population, which consisted of all randomized subjects who had study medication for at least once with assessment data post-dosing. Due to drop outs, there was difference in the population analyzed (n) for this outcome measure at each time point. Missing values were not imputed.
Mean daily dose of lozenges was calculated as number of lozenges taken at each visit divided by days since the last visit.
Outcome measures
| Measure |
Nicotine Lozenge 2 mg (Low Dependence Smokers)
n=232 Participants
Participants, who smoked their first cigarette after 30 minutes of waking, received 2 mg of nicotine lozenge orally.
|
Placebo Lozenge (Low Dependence Smokers)
n=237 Participants
Participants, who smoked their first cigarette after 30 minutes of waking, received placebo lozenge containing 0 mg of nicotine orally.
|
Nicotine Lozenge 4 mg (High Dependence Smokers)
n=117 Participants
Participants, who smoked their first cigarette within 30 minutes after waking, received 4 mg nicotine lozenge orally.
|
Placebo Lozenge (High Dependence Smokers)
n=111 Participants
Participants, who smoked their first cigarette within 30 minutes after waking, received placebo lozenge containing 0 mg of nicotine orally.
|
|---|---|---|---|---|
|
Mean Daily Dose at Visit 4, 5, 6, 7 and 10
Week 1-2 (n=232, 237, 117, 111)
|
8.96 Number of lozenges
Standard Deviation 3.32
|
8.59 Number of lozenges
Standard Deviation 3.23
|
8.81 Number of lozenges
Standard Deviation 3.57
|
8.52 Number of lozenges
Standard Deviation 3.16
|
|
Mean Daily Dose at Visit 4, 5, 6, 7 and 10
Week 3-4 (n=224, 231, 114, 107)
|
8.66 Number of lozenges
Standard Deviation 3.17
|
8.71 Number of lozenges
Standard Deviation 3.40
|
8.93 Number of lozenges
Standard Deviation 3.17
|
8.60 Number of lozenges
Standard Deviation 3.39
|
|
Mean Daily Dose at Visit 4, 5, 6, 7 and 10
Week 5-6 (n=223, 228, 113, 106)
|
8.15 Number of lozenges
Standard Deviation 3.39
|
8.07 Number of lozenges
Standard Deviation 3.30
|
8.55 Number of lozenges
Standard Deviation 3.32
|
8.09 Number of lozenges
Standard Deviation 3.43
|
|
Mean Daily Dose at Visit 4, 5, 6, 7 and 10
Weeks 7-12 (n=221, 224, 112, 106)
|
4.85 Number of lozenges
Standard Deviation 2.33
|
4.54 Number of lozenges
Standard Deviation 2.40
|
5.02 Number of lozenges
Standard Deviation 2.35
|
4.67 Number of lozenges
Standard Deviation 2.31
|
|
Mean Daily Dose at Visit 4, 5, 6, 7 and 10
Weeks 13-24 (n=222, 222, 105, 107)
|
0.89 Number of lozenges
Standard Deviation 1.05
|
0.78 Number of lozenges
Standard Deviation 1.04
|
0.95 Number of lozenges
Standard Deviation 0.90
|
0.84 Number of lozenges
Standard Deviation 0.92
|
SECONDARY outcome
Timeframe: Baseline, Week 6, 12 and Week 24Population: Analysis was carried out per FAS population, which consisted of all randomized subjects who had study medication for at least once with assessment data post-dosing. Due to drop outs, there was difference in the population analyzed (n) for this outcome measure at each time point i.e. Week 6, Week 12 and Week 24. Missing values were not imputed.
Change in body weight was analyzed at Weeks 6, 12, and 24.
Outcome measures
| Measure |
Nicotine Lozenge 2 mg (Low Dependence Smokers)
n=241 Participants
Participants, who smoked their first cigarette after 30 minutes of waking, received 2 mg of nicotine lozenge orally.
|
Placebo Lozenge (Low Dependence Smokers)
n=242 Participants
Participants, who smoked their first cigarette after 30 minutes of waking, received placebo lozenge containing 0 mg of nicotine orally.
|
Nicotine Lozenge 4 mg (High Dependence Smokers)
n=120 Participants
Participants, who smoked their first cigarette within 30 minutes after waking, received 4 mg nicotine lozenge orally.
|
Placebo Lozenge (High Dependence Smokers)
n=119 Participants
Participants, who smoked their first cigarette within 30 minutes after waking, received placebo lozenge containing 0 mg of nicotine orally.
|
|---|---|---|---|---|
|
Mean Change From Baseline in Body Weight at Week 6, Week 12 and Week 24/ Premature Termination.
Week 12 (n=221, 225, 112, 107)
|
1.2 kilogram (kg)
Standard Deviation 2.43
|
1.0 kilogram (kg)
Standard Deviation 2.40
|
1.9 kilogram (kg)
Standard Deviation 3.58
|
1.5 kilogram (kg)
Standard Deviation 2.17
|
|
Mean Change From Baseline in Body Weight at Week 6, Week 12 and Week 24/ Premature Termination.
Week 6 (n=225, 230, 115, 109)
|
0.9 kilogram (kg)
Standard Deviation 1.94
|
0.7 kilogram (kg)
Standard Deviation 2.21
|
1.2 kilogram (kg)
Standard Deviation 2.45
|
1.2 kilogram (kg)
Standard Deviation 2.16
|
|
Mean Change From Baseline in Body Weight at Week 6, Week 12 and Week 24/ Premature Termination.
Week 24 (n=221, 224, 111, 112)
|
1.3 kilogram (kg)
Standard Deviation 2.89
|
1.3 kilogram (kg)
Standard Deviation 2.81
|
2.2 kilogram (kg)
Standard Deviation 3.14
|
2.1 kilogram (kg)
Standard Deviation 2.50
|
SECONDARY outcome
Timeframe: Weekly assessments from first treatment dose up to 15 days after last treatment dosePopulation: Safety Population of this study consists of all randomized participants who have had study medication for at least once.
All AEs and SAEs were reviewed and reported by investigator. AEs were graded on a 3-point scale as Mild, Moderate and Severe.
Outcome measures
| Measure |
Nicotine Lozenge 2 mg (Low Dependence Smokers)
n=241 Participants
Participants, who smoked their first cigarette after 30 minutes of waking, received 2 mg of nicotine lozenge orally.
|
Placebo Lozenge (Low Dependence Smokers)
n=242 Participants
Participants, who smoked their first cigarette after 30 minutes of waking, received placebo lozenge containing 0 mg of nicotine orally.
|
Nicotine Lozenge 4 mg (High Dependence Smokers)
n=119 Participants
Participants, who smoked their first cigarette within 30 minutes after waking, received 4 mg nicotine lozenge orally.
|
Placebo Lozenge (High Dependence Smokers)
n=118 Participants
Participants, who smoked their first cigarette within 30 minutes after waking, received placebo lozenge containing 0 mg of nicotine orally.
|
|---|---|---|---|---|
|
Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), Cardiovascular AEs and Who Discontinued Due to AEs
AEs
|
111 Participants
|
91 Participants
|
61 Participants
|
58 Participants
|
|
Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), Cardiovascular AEs and Who Discontinued Due to AEs
SAEs
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), Cardiovascular AEs and Who Discontinued Due to AEs
Cardiovascular AEs
|
24 Participants
|
3 Participants
|
11 Participants
|
10 Participants
|
|
Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), Cardiovascular AEs and Who Discontinued Due to AEs
Discontinuation due to AEs
|
3 Participants
|
2 Participants
|
1 Participants
|
2 Participants
|
Adverse Events
Nicotine Lozenge 2 mg (Low Dependence Smokers)
Serious events: 1 serious events
Other events: 59 other events
Deaths: 0 deaths
Placebo Lozenge (Low Dependence Smokers)
Serious events: 0 serious events
Other events: 45 other events
Deaths: 0 deaths
Nicotine Lozenge 4 mg (High Dependence Smokers)
Serious events: 1 serious events
Other events: 43 other events
Deaths: 0 deaths
Placebo Lozenge (High Dependence Smokers)
Serious events: 1 serious events
Other events: 26 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Nicotine Lozenge 2 mg (Low Dependence Smokers)
n=241 participants at risk
Participants who smoked their first cigarette after 30 minutes after waking received 2 mg of nicotine lozenge, orally.
|
Placebo Lozenge (Low Dependence Smokers)
n=242 participants at risk
Participants who smoked their first cigarette after 30 minutes after waking received placebo lozenge containing 0 mg of nicotine, orally.
|
Nicotine Lozenge 4 mg (High Dependence Smokers)
n=119 participants at risk
Participants who smoked their first cigarette within 30 minutes after waking received 4 mg of nicotine lozenge, orally.
|
Placebo Lozenge (High Dependence Smokers)
n=118 participants at risk
Participants who smoked their first cigarette within 30 minutes after waking received placebo lozenge containing 0 mg of nicotine, orally.
|
|---|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Chronic Obstructive Pulmonary Disease
|
0.41%
1/241 • Number of events 1 • All adverse events that occured in time-period from the first administration of product to up to 15 days after the last dosing were recorded
Safety evaluation was done for saftey set population. There was one additional subject, randomized to 4mg Placebo, who withdrew consent, but was excluded from the SS population.
|
0.00%
0/242 • All adverse events that occured in time-period from the first administration of product to up to 15 days after the last dosing were recorded
Safety evaluation was done for saftey set population. There was one additional subject, randomized to 4mg Placebo, who withdrew consent, but was excluded from the SS population.
|
0.00%
0/119 • All adverse events that occured in time-period from the first administration of product to up to 15 days after the last dosing were recorded
Safety evaluation was done for saftey set population. There was one additional subject, randomized to 4mg Placebo, who withdrew consent, but was excluded from the SS population.
|
0.00%
0/118 • All adverse events that occured in time-period from the first administration of product to up to 15 days after the last dosing were recorded
Safety evaluation was done for saftey set population. There was one additional subject, randomized to 4mg Placebo, who withdrew consent, but was excluded from the SS population.
|
|
Skin and subcutaneous tissue disorders
Skin Laceration
|
0.00%
0/241 • All adverse events that occured in time-period from the first administration of product to up to 15 days after the last dosing were recorded
Safety evaluation was done for saftey set population. There was one additional subject, randomized to 4mg Placebo, who withdrew consent, but was excluded from the SS population.
|
0.00%
0/242 • All adverse events that occured in time-period from the first administration of product to up to 15 days after the last dosing were recorded
Safety evaluation was done for saftey set population. There was one additional subject, randomized to 4mg Placebo, who withdrew consent, but was excluded from the SS population.
|
0.84%
1/119 • Number of events 1 • All adverse events that occured in time-period from the first administration of product to up to 15 days after the last dosing were recorded
Safety evaluation was done for saftey set population. There was one additional subject, randomized to 4mg Placebo, who withdrew consent, but was excluded from the SS population.
|
0.00%
0/118 • All adverse events that occured in time-period from the first administration of product to up to 15 days after the last dosing were recorded
Safety evaluation was done for saftey set population. There was one additional subject, randomized to 4mg Placebo, who withdrew consent, but was excluded from the SS population.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/241 • All adverse events that occured in time-period from the first administration of product to up to 15 days after the last dosing were recorded
Safety evaluation was done for saftey set population. There was one additional subject, randomized to 4mg Placebo, who withdrew consent, but was excluded from the SS population.
|
0.00%
0/242 • All adverse events that occured in time-period from the first administration of product to up to 15 days after the last dosing were recorded
Safety evaluation was done for saftey set population. There was one additional subject, randomized to 4mg Placebo, who withdrew consent, but was excluded from the SS population.
|
0.00%
0/119 • All adverse events that occured in time-period from the first administration of product to up to 15 days after the last dosing were recorded
Safety evaluation was done for saftey set population. There was one additional subject, randomized to 4mg Placebo, who withdrew consent, but was excluded from the SS population.
|
0.85%
1/118 • Number of events 1 • All adverse events that occured in time-period from the first administration of product to up to 15 days after the last dosing were recorded
Safety evaluation was done for saftey set population. There was one additional subject, randomized to 4mg Placebo, who withdrew consent, but was excluded from the SS population.
|
Other adverse events
| Measure |
Nicotine Lozenge 2 mg (Low Dependence Smokers)
n=241 participants at risk
Participants who smoked their first cigarette after 30 minutes after waking received 2 mg of nicotine lozenge, orally.
|
Placebo Lozenge (Low Dependence Smokers)
n=242 participants at risk
Participants who smoked their first cigarette after 30 minutes after waking received placebo lozenge containing 0 mg of nicotine, orally.
|
Nicotine Lozenge 4 mg (High Dependence Smokers)
n=119 participants at risk
Participants who smoked their first cigarette within 30 minutes after waking received 4 mg of nicotine lozenge, orally.
|
Placebo Lozenge (High Dependence Smokers)
n=118 participants at risk
Participants who smoked their first cigarette within 30 minutes after waking received placebo lozenge containing 0 mg of nicotine, orally.
|
|---|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Nasopharyngitis
|
6.6%
16/241 • All adverse events that occured in time-period from the first administration of product to up to 15 days after the last dosing were recorded
Safety evaluation was done for saftey set population. There was one additional subject, randomized to 4mg Placebo, who withdrew consent, but was excluded from the SS population.
|
5.8%
14/242 • All adverse events that occured in time-period from the first administration of product to up to 15 days after the last dosing were recorded
Safety evaluation was done for saftey set population. There was one additional subject, randomized to 4mg Placebo, who withdrew consent, but was excluded from the SS population.
|
10.9%
13/119 • All adverse events that occured in time-period from the first administration of product to up to 15 days after the last dosing were recorded
Safety evaluation was done for saftey set population. There was one additional subject, randomized to 4mg Placebo, who withdrew consent, but was excluded from the SS population.
|
4.2%
5/118 • All adverse events that occured in time-period from the first administration of product to up to 15 days after the last dosing were recorded
Safety evaluation was done for saftey set population. There was one additional subject, randomized to 4mg Placebo, who withdrew consent, but was excluded from the SS population.
|
|
Gastrointestinal disorders
Nausea
|
6.2%
15/241 • All adverse events that occured in time-period from the first administration of product to up to 15 days after the last dosing were recorded
Safety evaluation was done for saftey set population. There was one additional subject, randomized to 4mg Placebo, who withdrew consent, but was excluded from the SS population.
|
4.1%
10/242 • All adverse events that occured in time-period from the first administration of product to up to 15 days after the last dosing were recorded
Safety evaluation was done for saftey set population. There was one additional subject, randomized to 4mg Placebo, who withdrew consent, but was excluded from the SS population.
|
5.9%
7/119 • All adverse events that occured in time-period from the first administration of product to up to 15 days after the last dosing were recorded
Safety evaluation was done for saftey set population. There was one additional subject, randomized to 4mg Placebo, who withdrew consent, but was excluded from the SS population.
|
6.8%
8/118 • All adverse events that occured in time-period from the first administration of product to up to 15 days after the last dosing were recorded
Safety evaluation was done for saftey set population. There was one additional subject, randomized to 4mg Placebo, who withdrew consent, but was excluded from the SS population.
|
|
Cardiac disorders
Dyspnoea
|
0.41%
1/241 • All adverse events that occured in time-period from the first administration of product to up to 15 days after the last dosing were recorded
Safety evaluation was done for saftey set population. There was one additional subject, randomized to 4mg Placebo, who withdrew consent, but was excluded from the SS population.
|
0.83%
2/242 • All adverse events that occured in time-period from the first administration of product to up to 15 days after the last dosing were recorded
Safety evaluation was done for saftey set population. There was one additional subject, randomized to 4mg Placebo, who withdrew consent, but was excluded from the SS population.
|
5.0%
6/119 • All adverse events that occured in time-period from the first administration of product to up to 15 days after the last dosing were recorded
Safety evaluation was done for saftey set population. There was one additional subject, randomized to 4mg Placebo, who withdrew consent, but was excluded from the SS population.
|
1.7%
2/118 • All adverse events that occured in time-period from the first administration of product to up to 15 days after the last dosing were recorded
Safety evaluation was done for saftey set population. There was one additional subject, randomized to 4mg Placebo, who withdrew consent, but was excluded from the SS population.
|
|
Respiratory, thoracic and mediastinal disorders
Upper Respiratory Tract Infection
|
11.2%
27/241 • All adverse events that occured in time-period from the first administration of product to up to 15 days after the last dosing were recorded
Safety evaluation was done for saftey set population. There was one additional subject, randomized to 4mg Placebo, who withdrew consent, but was excluded from the SS population.
|
7.9%
19/242 • All adverse events that occured in time-period from the first administration of product to up to 15 days after the last dosing were recorded
Safety evaluation was done for saftey set population. There was one additional subject, randomized to 4mg Placebo, who withdrew consent, but was excluded from the SS population.
|
14.3%
17/119 • All adverse events that occured in time-period from the first administration of product to up to 15 days after the last dosing were recorded
Safety evaluation was done for saftey set population. There was one additional subject, randomized to 4mg Placebo, who withdrew consent, but was excluded from the SS population.
|
9.3%
11/118 • All adverse events that occured in time-period from the first administration of product to up to 15 days after the last dosing were recorded
Safety evaluation was done for saftey set population. There was one additional subject, randomized to 4mg Placebo, who withdrew consent, but was excluded from the SS population.
|
Additional Information
GSK Response Center
GlaxoSmithKline
Phone: 866-435-7343
Results disclosure agreements
- Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER