Trial Outcomes & Findings for Nicotine Mouth Film for Craving Relief. (NCT NCT01702532)
NCT ID: NCT01702532
Last Updated: 2014-01-30
Results Overview
Participants completed a cigarette craving assessment consisting of the following five items: "I have a desire for a cigarette right now; If it were possible I would smoke right now; All I want right now is a cigarette; I have an urge for a cigarette; I crave a cigarette right now. All participants indicated craving intensity on a pre-drawn 100 millimeter (mm) Visual Analog Scale (VAS) ranging from 0 (disagree) to 100 (agree). The average of the scores over the five items was defined as craving score for each time point.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
320 participants
Primary outcome timeframe
Pre-dosing post-provocation to 50 seconds
Results posted on
2014-01-30
Participant Flow
Participants were recruited at the clinical site.
A total of 386 participants were screened of which 322 subjects were randomized into the study. Sixty subjects were screen failures, Two subjects withdrew consent and an additional 2 subjects were not randomized due to other reasons.
Participant milestones
| Measure |
Nicotine Mouth Film 2.5 mg
Participants received a single dose of 2.5 mg nicotine mouth film placed on the top of tongue and pressed to the roof of mouth until film dissolved (approximately 2 to 3 minutes).
|
Nicotine Lozenge 2 mg
Participants received a single dose of 2 mg nicotine lozenge to be placed into the mouth and periodically moved from one side of mouth to other, without swallowing until lozenge dissolved (approximately 20 to 30 minutes).
|
|---|---|---|
|
Overall Study
STARTED
|
161
|
161
|
|
Overall Study
Safety Population
|
161
|
160
|
|
Overall Study
COMPLETED
|
161
|
160
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
Nicotine Mouth Film 2.5 mg
Participants received a single dose of 2.5 mg nicotine mouth film placed on the top of tongue and pressed to the roof of mouth until film dissolved (approximately 2 to 3 minutes).
|
Nicotine Lozenge 2 mg
Participants received a single dose of 2 mg nicotine lozenge to be placed into the mouth and periodically moved from one side of mouth to other, without swallowing until lozenge dissolved (approximately 20 to 30 minutes).
|
|---|---|---|
|
Overall Study
Adverse Event
|
0
|
1
|
Baseline Characteristics
Nicotine Mouth Film for Craving Relief.
Baseline characteristics by cohort
| Measure |
Nicotine Mouth Film 2.5 mg
n=161 Participants
Participants received a single dose of 2.5 mg nicotine mouth film placed on the top of tongue and pressed to the roof of mouth until film dissolved (approximately 2 to 3 minutes).
|
Nicotine Lozenge 2 mg
n=160 Participants
Participants received a single dose of 2 mg nicotine lozenge to be placed into the mouth and periodically moved from one side of mouth to other, without swallowing until lozenge dissolved (approximately 20 - 30 minutes).
|
Total
n=321 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
39.0 Years
STANDARD_DEVIATION 12.91 • n=5 Participants
|
39.8 Years
STANDARD_DEVIATION 12.64 • n=7 Participants
|
39.4 Years
STANDARD_DEVIATION 12.76 • n=5 Participants
|
|
Sex: Female, Male
Female
|
89 Participants
n=5 Participants
|
73 Participants
n=7 Participants
|
162 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
72 Participants
n=5 Participants
|
87 Participants
n=7 Participants
|
159 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Pre-dosing post-provocation to 50 secondsPopulation: All randomized participants who took at least one dose of medication and provided at least one valid craving assessment measurement on-treatment. Any participant with a missing response to any of the five craving assessment items was considered as a missing value and was imputed.
Participants completed a cigarette craving assessment consisting of the following five items: "I have a desire for a cigarette right now; If it were possible I would smoke right now; All I want right now is a cigarette; I have an urge for a cigarette; I crave a cigarette right now. All participants indicated craving intensity on a pre-drawn 100 millimeter (mm) Visual Analog Scale (VAS) ranging from 0 (disagree) to 100 (agree). The average of the scores over the five items was defined as craving score for each time point.
Outcome measures
| Measure |
Nicotine Mouth Film 2.5 mg
n=161 Participants
Participants received a single dose of 2.5 mg nicotine mouth film placed on the top of tongue and pressed to the roof of mouth until film dissolved (approximately 2 to 3 minutes).
|
Nicotine Lozenge 2 mg
n=160 Participants
Participants received a single dose of 2 mg nicotine lozenge to be placed into the mouth and periodically moved from one side of mouth to other, without swallowing until lozenge dissolved (approximately 20 - 30 minutes)
|
|---|---|---|
|
The Change From Pre-dose Post-provocation in Craving Score at 50 Seconds
|
-14.15 mm
Interval -16.9 to -11.41
|
-9.26 mm
Interval -12.01 to -6.5
|
SECONDARY outcome
Timeframe: Pre-dosing post-provocation to 3, 5, 7, 10, 15, 20, 25, and 30 minutesParticipants completed a cigarette craving assessment consisting of the following five items: "I have a desire for a cigarette right now; If it were possible I would smoke right now; All I want right now is a cigarette; I have an urge for a cigarette; I crave a cigarette right now. All participants indicated craving intensity on a pre-drawn 100 mm VAS ranging from 0 (disagree) to 100 (agree). The average of the scores over the five items was defined as the craving score for each time .
Outcome measures
| Measure |
Nicotine Mouth Film 2.5 mg
n=161 Participants
Participants received a single dose of 2.5 mg nicotine mouth film placed on the top of tongue and pressed to the roof of mouth until film dissolved (approximately 2 to 3 minutes).
|
Nicotine Lozenge 2 mg
n=160 Participants
Participants received a single dose of 2 mg nicotine lozenge to be placed into the mouth and periodically moved from one side of mouth to other, without swallowing until lozenge dissolved (approximately 20 - 30 minutes)
|
|---|---|---|
|
The Change From Pre-dose Post-provocation in Craving Score at 3, 5, 7, 10, 15, 20, 25, and 30 Minutes
Difference in VAS Score at 3 Minutes
|
-27.02 mm
Interval -30.64 to -23.39
|
-20.30 mm
Interval -23.93 to -16.67
|
|
The Change From Pre-dose Post-provocation in Craving Score at 3, 5, 7, 10, 15, 20, 25, and 30 Minutes
Difference in VAS Score at 5 Minutes
|
-33.95 mm
Interval -37.88 to -30.02
|
-28.33 mm
Interval -32.27 to -24.38
|
|
The Change From Pre-dose Post-provocation in Craving Score at 3, 5, 7, 10, 15, 20, 25, and 30 Minutes
Difference in VAS Score at 7 Minutes
|
-39.13 mm
Interval -43.2 to -35.05
|
-34.14 mm
Interval -38.23 to -30.05
|
|
The Change From Pre-dose Post-provocation in Craving Score at 3, 5, 7, 10, 15, 20, 25, and 30 Minutes
Difference in VAS Score at 10 Minutes
|
-40.94 mm
Interval -45.08 to -36.8
|
-39.16 mm
Interval -43.31 to -35.01
|
|
The Change From Pre-dose Post-provocation in Craving Score at 3, 5, 7, 10, 15, 20, 25, and 30 Minutes
Difference in VAS Score at 15 Minutes
|
-42.19 mm
Interval -46.42 to -37.97
|
-42.30 mm
Interval -46.53 to -38.06
|
|
The Change From Pre-dose Post-provocation in Craving Score at 3, 5, 7, 10, 15, 20, 25, and 30 Minutes
Difference in VAS Score at 20 Minutes
|
-42.43 mm
Interval -46.77 to -38.09
|
-45.23 mm
Interval -49.58 to -40.87
|
|
The Change From Pre-dose Post-provocation in Craving Score at 3, 5, 7, 10, 15, 20, 25, and 30 Minutes
Difference in VAS Score at 25 Minutes
|
-43.16 mm
Interval -47.55 to -38.78
|
-46.27 mm
Interval -50.67 to -41.88
|
|
The Change From Pre-dose Post-provocation in Craving Score at 3, 5, 7, 10, 15, 20, 25, and 30 Minutes
Difference in VAS Score at 30 Minutes
|
-43.54 mm
Interval -48.11 to -38.97
|
-47.48 mm
Interval -52.06 to -42.89
|
Adverse Events
Nicotine Mouth Film 2.5 mg
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Nicotine Lozenge 2 mg
Serious events: 0 serious events
Other events: 29 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Nicotine Mouth Film 2.5 mg
n=161 participants at risk
Participants received a single dose of 2.5 mg nicotine mouth film placed on the top of tongue and pressed to the roof of mouth until film dissolved (approximately 2 to 3 minutes).
|
Nicotine Lozenge 2 mg
n=160 participants at risk
Participants received a single dose of 2 mg nicotine lozenge to be placed into the mouth and periodically moved from one side of mouth to other, without swallowing until lozenge dissolved (approximately 20 to 30 minutes).
|
|---|---|---|
|
Gastrointestinal disorders
Nausea
|
0.62%
1/161 • Number of events 1 • AEs were collected from the start of the sequestration period upto 5 days after the last treament
|
8.8%
14/160 • Number of events 14 • AEs were collected from the start of the sequestration period upto 5 days after the last treament
|
|
Gastrointestinal disorders
Epigastric Discomfort
|
0.62%
1/161 • Number of events 1 • AEs were collected from the start of the sequestration period upto 5 days after the last treament
|
1.2%
2/160 • Number of events 2 • AEs were collected from the start of the sequestration period upto 5 days after the last treament
|
|
Respiratory, thoracic and mediastinal disorders
Throat Irritation
|
0.62%
1/161 • Number of events 1 • AEs were collected from the start of the sequestration period upto 5 days after the last treament
|
3.1%
5/160 • Number of events 5 • AEs were collected from the start of the sequestration period upto 5 days after the last treament
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.62%
1/161 • Number of events 1 • AEs were collected from the start of the sequestration period upto 5 days after the last treament
|
2.5%
4/160 • Number of events 4 • AEs were collected from the start of the sequestration period upto 5 days after the last treament
|
|
Nervous system disorders
Dizziness
|
0.00%
0/161 • AEs were collected from the start of the sequestration period upto 5 days after the last treament
|
1.9%
3/160 • Number of events 3 • AEs were collected from the start of the sequestration period upto 5 days after the last treament
|
|
Gastrointestinal disorders
Abdominal Discomfort
|
0.00%
0/161 • AEs were collected from the start of the sequestration period upto 5 days after the last treament
|
1.2%
2/160 • Number of events 2 • AEs were collected from the start of the sequestration period upto 5 days after the last treament
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
0.62%
1/161 • Number of events 1 • AEs were collected from the start of the sequestration period upto 5 days after the last treament
|
0.00%
0/160 • AEs were collected from the start of the sequestration period upto 5 days after the last treament
|
|
Gastrointestinal disorders
Dyspepsia
|
0.62%
1/161 • Number of events 1 • AEs were collected from the start of the sequestration period upto 5 days after the last treament
|
0.00%
0/160 • AEs were collected from the start of the sequestration period upto 5 days after the last treament
|
|
Gastrointestinal disorders
Gastroesophageal Reflux Disease
|
0.00%
0/161 • AEs were collected from the start of the sequestration period upto 5 days after the last treament
|
0.62%
1/160 • Number of events 1 • AEs were collected from the start of the sequestration period upto 5 days after the last treament
|
|
Nervous system disorders
Headache
|
0.00%
0/161 • AEs were collected from the start of the sequestration period upto 5 days after the last treament
|
0.62%
1/160 • Number of events 1 • AEs were collected from the start of the sequestration period upto 5 days after the last treament
|
|
Vascular disorders
Flushing
|
0.00%
0/161 • AEs were collected from the start of the sequestration period upto 5 days after the last treament
|
0.62%
1/160 • Number of events 1 • AEs were collected from the start of the sequestration period upto 5 days after the last treament
|
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