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A multi-center, randomized, double-blind, placebo-controlled, 4-arm clinical study to evaluate efficacy and safety of nicotine lozenge (2mg and 4mg) in smoking cessation in adult cigarette smokers who are motivated to quit smoking. Successful quitters or participants who smoke occasionally will be followed up after week 24 till 12 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 2mg nicotine lozenge | Experimental | 2 mg nicotine lozenge |
|
| 2 mg placebo | Placebo Comparator | 2 mg placebo |
|
| 4 mg nicotine lozenge | Experimental | 4 mg nicotine lozenge |
|
| 4 mg placebo | Placebo Comparator | 4 mg placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nicotine | Drug | 2 mg or 4 mg nicotine lozenge |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of Successful Smoking Cessation at Week 6 | Rate of Successful Smoking Cessation at Week 6 was measured by Carbon Monoxide (CO) breath levels. | From baseline to Week 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of Continuous Successful Smoking Cessation at Week 12 and Week 24 | Continuous abstinence was verified by measurement of CO breath levels. | From baseline to Week 12 and Week 24 |
| Rate of Long-term Successful Smoking Cessation at Week 24 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34611902 | Derived | Hartmann-Boyce J, Theodoulou A, Farley A, Hajek P, Lycett D, Jones LL, Kudlek L, Heath L, Hajizadeh A, Schenkels M, Aveyard P. Interventions for preventing weight gain after smoking cessation. Cochrane Database Syst Rev. 2021 Oct 6;10(10):CD006219. doi: 10.1002/14651858.CD006219.pub4. |
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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.
Participants were recruited at the clinical site.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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 |
| FG002 | 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. |
| FG003 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Nicotine Lozenge 2 mg (Low Dependence Smokers) | Participants who smoked their first cigarette after 30 minutes of waking received 2 mg of nicotine lozenge, orally. |
| BG001 | Placebo Lozenge (Low Dependence Smokers) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Baseline parameters were evaluated for FAS population. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Rate of Successful Smoking Cessation at Week 6 | Rate of Successful Smoking Cessation at Week 6 was measured by Carbon Monoxide (CO) breath levels. | 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. | Posted | Number | Percentage of participants | From baseline to Week 6 |
|
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Nicotine Lozenge 2 mg (Low Dependence Smokers) | Participants who smoked their first cigarette after 30 minutes after waking received 2 mg of nicotine lozenge, orally. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Chronic Obstructive Pulmonary Disease | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 |
| ID | Term |
|---|---|
| D012907 | Smoking |
| D016540 | Smoking Cessation |
| ID | Term |
|---|---|
| D001519 | Behavior |
| D015438 | Health Behavior |
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| ID | Term |
|---|---|
| D009538 | Nicotine |
| ID | Term |
|---|---|
| D012991 | Solanaceous Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D011725 | Pyridines |
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| Placebo |
| Drug |
placebo lozenge |
|
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.
| From Week 6 to Week 24 |
| Proportion of Participants With Seven Day Point Prevalence Abstinence | Seven day point prevalence abstinence was defined as complete abstinence from smoking for the 7 days up to and including the evaluation day. | Weekly assessment at Week 1, 2, 4, 6, 12 and Week 24 |
| Mean Score of Relief of Craving/ Total Withdrawal Symptoms | 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. | Weekly assessment at Week 1, 2, 3, 4, 5 and Week 6 |
| Mean Daily Dose at Visit 4, 5, 6, 7 and 10 | Mean daily dose of lozenges was calculated as number of lozenges taken at each visit divided by days since the last visit. | Weeks 1-2, 3-4, 5-6, 7-12 and 13-24 |
| Mean Change From Baseline in Body Weight at Week 6, Week 12 and Week 24/ Premature Termination. | Change in body weight was analyzed at Weeks 6, 12, and 24. | Baseline, Week 6, 12 and Week 24 |
| Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), Cardiovascular AEs and Who Discontinued Due to AEs | All AEs and SAEs were reviewed and reported by investigator. AEs were graded on a 3-point scale as Mild, Moderate and Severe. | Weekly assessments from first treatment dose up to 15 days after last treatment dose |
| Lost to Follow-up |
|
| Protocol Violation |
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| Lack of Efficacy |
|
| Withdrawal by Subject |
|
| Other Reason |
|
Participants who smoked their first cigarette after 30 minutes of waking received placebo lozenge containing 0 mg of nicotine, orally.
| BG002 | Nicotine Lozenge 4 mg (High Dependence Smokers) | Participants who smoked their first cigarette within 30 minutes after waking received 4 mg nicotine lozenge, orally. |
| BG003 | Placebo Lozenge (High Dependence Smokers) | Participants who smoked their first cigarette within 30 minutes after waking received placebo lozenge containing 0 mg of nicotine, orally. |
| BG004 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| Years |
|
| Sex: Female, Male | Baseline parameter were evaluated for FAS population. | Count of Participants | Participants |
|
| Body Weight | Baseline Parameters were evaluated for FAS population. | Mean | Standard Deviation | Kg |
|
Participants, who smoked their first cigarette after 30 minutes of waking, received placebo lozenge containing 0 mg of nicotine orally.
| OG002 | Nicotine Lozenge 4 mg (High Dependence Smokers) | Participants, who smoked their first cigarette within 30 minutes after waking, received 4 mg nicotine lozenge orally. |
| OG003 | Placebo Lozenge (High Dependence Smokers) | Participants, who smoked their first cigarette within 30 minutes after waking, received placebo lozenge containing 0 mg of nicotine orally. |
|
|
|
| Secondary | Rate of Continuous Successful Smoking Cessation at Week 12 and Week 24 | Continuous abstinence was verified by measurement of CO breath levels. | 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. | Posted | Number | Percentage of participants | From baseline to Week 12 and Week 24 |
|
|
|
| Secondary | Rate of Long-term Successful Smoking Cessation at Week 24 | 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. | 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. | Posted | Number | Percentage of participants | From Week 6 to Week 24 |
|
|
|
| Secondary | Proportion of Participants With Seven Day Point Prevalence Abstinence | Seven day point prevalence abstinence was defined as complete abstinence from smoking for the 7 days up to and including the evaluation day. | 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. | Posted | Number | Percentage of participants | Weekly assessment at Week 1, 2, 4, 6, 12 and Week 24 |
|
|
|
| Secondary | Mean Score of Relief of Craving/ Total Withdrawal Symptoms | 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. | 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. | Posted | Mean | Standard Deviation | Score on a scale | Weekly assessment at Week 1, 2, 3, 4, 5 and Week 6 |
|
|
|
| Secondary | Mean Daily Dose at Visit 4, 5, 6, 7 and 10 | Mean daily dose of lozenges was calculated as number of lozenges taken at each visit divided by days since the last visit. | 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. | Posted | Mean | Standard Deviation | Number of lozenges | Weeks 1-2, 3-4, 5-6, 7-12 and 13-24 |
|
|
|
| Secondary | Mean Change From Baseline in Body Weight at Week 6, Week 12 and Week 24/ Premature Termination. | Change in body weight was analyzed at Weeks 6, 12, and 24. | 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. | Posted | Mean | Standard Deviation | kilogram (kg) | Baseline, Week 6, 12 and Week 24 |
|
|
|
| Secondary | Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), Cardiovascular AEs and Who Discontinued Due to AEs | All AEs and SAEs were reviewed and reported by investigator. AEs were graded on a 3-point scale as Mild, Moderate and Severe. | Safety Population of this study consists of all randomized participants who have had study medication for at least once. | Posted | Number | Participants | Weekly assessments from first treatment dose up to 15 days after last treatment dose |
|
|
|
| 1 |
| 241 |
| 59 |
| 241 |
| EG001 | Placebo Lozenge (Low Dependence Smokers) | Participants who smoked their first cigarette after 30 minutes after waking received placebo lozenge containing 0 mg of nicotine, orally. | 0 | 242 | 45 | 242 |
| EG002 | Nicotine Lozenge 4 mg (High Dependence Smokers) | Participants who smoked their first cigarette within 30 minutes after waking received 4 mg of nicotine lozenge, orally. | 1 | 119 | 43 | 119 |
| EG003 | Placebo Lozenge (High Dependence Smokers) | Participants who smoked their first cigarette within 30 minutes after waking received placebo lozenge containing 0 mg of nicotine, orally. | 1 | 118 | 26 | 118 |
| Skin Laceration | Skin and subcutaneous tissue disorders | MedDRA 11.0 | Systematic Assessment |
|
| Cholelithiasis | Hepatobiliary disorders | MedDRA 11.0 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| Dyspnoea | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
|
| Upper Respiratory Tract Infection | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
|
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.
| D006573 |
| Heterocyclic Compounds, 1-Ring |
| Smoking Cessation Rate at 24 weeks |
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| Week 2 |
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| Week 4 |
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| Week 6 |
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| Week 12 |
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| Week 24 |
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| Week 2 (n=230, 233, 112, 115) |
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| Week 3 (n=226, 232, 115, 110) |
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| Week 4 (n=225, 226, 113, 108) |
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| Week 5 (n=221, 229, 112, 104) |
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| Week 6 (215, 223, 103, 102) |
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| Week 3-4 (n=224, 231, 114, 107) |
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| Week 5-6 (n=223, 228, 113, 106) |
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| Weeks 7-12 (n=221, 224, 112, 106) |
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| Weeks 13-24 (n=222, 222, 105, 107) |
|
| Week 12 (n=221, 225, 112, 107) |
|
| Week 24 (n=221, 224, 111, 112) |
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| SAEs |
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| Cardiovascular AEs |
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| Discontinuation due to AEs |
|