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Nicotine Mouth Film for Craving Relief.

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ClinicalTrials.gov Identifier: NCT01702532
Recruitment Status : Completed
First Posted : October 8, 2012
Results First Posted : January 30, 2014
Last Update Posted : January 30, 2014
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Smoking Cessation
Intervention Drug: Nicotine
Enrollment 320

Recruitment Details Participants were recruited at the clinical site.
Pre-assignment Details 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.
Arm/Group Title Nicotine Mouth Film 2.5 mg Nicotine Lozenge 2 mg
Hide Arm/Group Description 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). 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).
Period Title: Overall Study
Started 161 161
Safety Population 161 160 [1]
Completed 161 160
Not Completed 0 1
Reason Not Completed
Adverse Event             0             1
[1]
One subject randomized but did not receive the study treatment.
Arm/Group Title Nicotine Mouth Film 2.5 mg Nicotine Lozenge 2 mg Total
Hide Arm/Group Description 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). 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 of all reporting groups
Overall Number of Baseline Participants 161 160 321
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 161 participants 160 participants 321 participants
39.0  (12.91) 39.8  (12.64) 39.4  (12.76)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 161 participants 160 participants 321 participants
Female
89
  55.3%
73
  45.6%
162
  50.5%
Male
72
  44.7%
87
  54.4%
159
  49.5%
1.Primary Outcome
Title The Change From Pre-dose Post-provocation in Craving Score at 50 Seconds
Hide Description 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.
Time Frame Pre-dosing post-provocation to 50 seconds
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Nicotine Mouth Film 2.5 mg Nicotine Lozenge 2 mg
Hide Arm/Group Description:
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).
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)
Overall Number of Participants Analyzed 161 160
Least Squares Mean (Inter-Quartile Range)
Unit of Measure: mm
-14.15
(-16.90 to -11.41)
-9.26
(-12.01 to -6.50)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Nicotine Mouth Film 2.5 mg, Nicotine Lozenge 2 mg
Comments Null hypotheses considered change in craving score means from pre-dose post-provocation at 50 seconds to be equal for the two treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0141
Comments The comparison between treatments was conducted in a hierarchical order; consequently no adjustment of the significance level (5%) for multiplicity was needed.
Method ANCOVA
Comments ANCOVA model contains pre-provocation baseline, pre-dosing post-provocation craving score, and the terms treatment groups and center as fixed
Method of Estimation Estimation Parameter LS Means Difference
Estimated Value -4.90
Confidence Interval (2-Sided) 95%
-8.80 to -0.99
Estimation Comments Comment: The confidence interval is for the difference between treatments groups
2.Secondary Outcome
Title The Change From Pre-dose Post-provocation in Craving Score at 3, 5, 7, 10, 15, 20, 25, and 30 Minutes
Hide Description 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 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 .
Time Frame Pre-dosing post-provocation to 3, 5, 7, 10, 15, 20, 25, and 30 minutes
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Nicotine Mouth Film 2.5 mg Nicotine Lozenge 2 mg
Hide Arm/Group Description:
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).
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).
Overall Number of Participants Analyzed 161 160
Least Squares Mean (95% Confidence Interval)
Unit of Measure: mm
Difference in VAS Score at 3 Minutes
-27.02
(-30.64 to -23.39)
-20.30
(-23.93 to -16.67)
Difference in VAS Score at 5 Minutes
-33.95
(-37.88 to -30.02)
-28.33
(-32.27 to -24.38)
Difference in VAS Score at 7 Minutes
-39.13
(-43.20 to -35.05)
-34.14
(-38.23 to -30.05)
Difference in VAS Score at 10 Minutes
-40.94
(-45.08 to -36.80)
-39.16
(-43.31 to -35.01)
Difference in VAS Score at 15 Minutes
-42.19
(-46.42 to -37.97)
-42.30
(-46.53 to -38.06)
Difference in VAS Score at 20 Minutes
-42.43
(-46.77 to -38.09)
-45.23
(-49.58 to -40.87)
Difference in VAS Score at 25 Minutes
-43.16
(-47.55 to -38.78)
-46.27
(-50.67 to -41.88)
Difference in VAS Score at 30 Minutes
-43.54
(-48.11 to -38.97)
-47.48
(-52.06 to -42.89)
Time Frame AEs were collected from the start of the sequestration period upto 5 days after the last treament
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Nicotine Mouth Film 2.5 mg Nicotine Lozenge 2 mg
Hide Arm/Group Description 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). 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).
All-Cause Mortality
Nicotine Mouth Film 2.5 mg Nicotine Lozenge 2 mg
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Nicotine Mouth Film 2.5 mg Nicotine Lozenge 2 mg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/161 (0.00%)      0/160 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Nicotine Mouth Film 2.5 mg Nicotine Lozenge 2 mg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   6/161 (3.73%)      29/160 (18.13%)    
Gastrointestinal disorders     
Nausea   1/161 (0.62%)  1 14/160 (8.75%)  14
Epigastric Discomfort   1/161 (0.62%)  1 2/160 (1.25%)  2
Abdominal Discomfort   0/161 (0.00%)  0 2/160 (1.25%)  2
Abdominal Pain Upper   1/161 (0.62%)  1 0/160 (0.00%)  0
Dyspepsia   1/161 (0.62%)  1 0/160 (0.00%)  0
Gastroesophageal Reflux Disease   0/161 (0.00%)  0 1/160 (0.63%)  1
Nervous system disorders     
Dizziness   0/161 (0.00%)  0 3/160 (1.88%)  3
Headache   0/161 (0.00%)  0 1/160 (0.63%)  1
Respiratory, thoracic and mediastinal disorders     
Throat Irritation   1/161 (0.62%)  1 5/160 (3.13%)  5
Hiccups   1/161 (0.62%)  1 4/160 (2.50%)  4
Vascular disorders     
Flushing   0/161 (0.00%)  0 1/160 (0.63%)  1
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
Phone: 866-435-7343
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01702532     History of Changes
Other Study ID Numbers: RH01589
First Submitted: October 4, 2012
First Posted: October 8, 2012
Results First Submitted: December 12, 2013
Results First Posted: January 30, 2014
Last Update Posted: January 30, 2014