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This study is designed to assess the ability of the mint nicotine mouth strip to relieve provoked cigarette craving in light smokers compared to nicotine lozenge and nicotine gum.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nicotine mouth strip | Experimental | single dose |
|
| nicotine lozenge | Active Comparator | single dose |
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| nicotine gum | Active Comparator | single dose |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| nicotine | Drug | nicotine in the form of a mouth strip, lozenge and gum |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change From Baseline in Nicotine Craving Score on a VAS | Participants completed a nicotine craving assessment consisting of 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 their craving intensity on a pre-drawn 100 mm scale ranging from 0 (disagree) to 100 (agree). At the end of the craving assessment period, mean VAS score was measured. | Baseline, 50 seconds, 3, 5, 7, 10, 15, 20, 25 and 30 minutes post treatment administration |
| Measure | Description | Time Frame |
|---|---|---|
| Log Transformed Area Under the Curve of Nicotine Craving Score (AUC) | AUC between the baseline (pre-dose) and the time of measurement of craving on-treatment was determined. | Baseline, 50 seconds, 3, 5, 7, 10, 15, 20, 25, and 30 minutes post treatment administration |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Central Kentucky Research Associates, Inc. | Lexington | Kentucky | 40509 | United States |
Of 140 screened participants, 120 were randomized while 17 participants were screen failures, and 3 participants were not randomized due to other reasons.
Participants were recruited at the clinical site.
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| ID | Title | Description |
|---|---|---|
| FG000 | Nicotine Mouth Strip 2.5 Milligram (mg) | Participants self administered a single dose of 2.5 mg nicotine mouth strip. |
| FG001 | Nicotine Lozenge 2 mg | Participants self administered a single dose of 2 mg nicotine lozenge. |
| FG002 | Nicotine Gum 2 mg | Participants self administered a single dose of 2 mg nicotine gum. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Nicotine Mouth Strip 2.5 mg | Participants self administered a single dose of 2.5 mg nicotine mouth strip. |
| BG001 | Nicotine Lozenge 2 mg | Participants self administered a single dose of 2 mg nicotine lozenge. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean |
| 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 | Mean Change From Baseline in Nicotine Craving Score on a VAS | Participants completed a nicotine craving assessment consisting of 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 their craving intensity on a pre-drawn 100 mm scale ranging from 0 (disagree) to 100 (agree). At the end of the craving assessment period, mean VAS score was measured. | Intent to Treat (ITT) Population: All randomized participants who had at least one dose of medication and provided at least one craving assessment measurement on treatment. The imputation of missing craving score was based on last observation carried forward (LOCF) technique. | Posted | Mean | Standard Deviation | Score on a scale | Baseline, 50 seconds, 3, 5, 7, 10, 15, 20, 25 and 30 minutes post treatment administration |
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AEs were collected from the start of the smoking abstinence sequestration period and until 5 days following last administration of the investigational product.
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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 Mouth Strip 2.5 mg | Participants self administered single dose of 2.5 mg nicotine mouth strip. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausae | Gastrointestinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 |
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| ID | Term |
|---|---|
| D016540 | Smoking Cessation |
| ID | Term |
|---|---|
| D015438 | Health Behavior |
| D001519 | 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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| BG002 | Nicotine Gum 2 mg | Participants self administered a single dose of 2 mg nicotine lozenge. |
| BG003 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
Participants self administered a single dose of 2.5 mg nicotine mouth strip. |
| OG001 | Nicotine Lozenge 2 mg | Participants self administered a single dose of 2 mg nicotine lozenge. |
| OG002 | Nicotine Gum 2 mg | Participants self administered a single dose of 2 mg nicotine gum. |
|
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| Secondary | Log Transformed Area Under the Curve of Nicotine Craving Score (AUC) | AUC between the baseline (pre-dose) and the time of measurement of craving on-treatment was determined. | Intent to Treat (ITT) Population: All randomized participants who had at least one dose of medication and provided at least one craving assessment measurement on treatment. The imputation of missing craving score was based on LOCF technique. | Posted | Log Mean | 95% Confidence Interval | Score on a scale*minutes | Baseline, 50 seconds, 3, 5, 7, 10, 15, 20, 25, and 30 minutes post treatment administration |
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| 0 |
| 40 |
| 1 |
| 40 |
| EG001 | Nicotine Lozenge 2 mg | Participants self administered single dose of 2 mg nicotine lozenge. | 0 | 40 | 4 | 40 |
| EG002 | Nicotine Gum 2 mg | Participants self administered single dose of 2 mg nicotine gum. | 0 | 40 | 0 | 40 |
| Hiccups | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Throat Irritation | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Dizziness | Nervous system disorders | Systematic Assessment |
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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 |
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