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Evaluation of the ability of a nicotine mini lozenge to provide early relief of craving for a cigarette in smokers
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nicotine Polacrilex mint mini lozenge | Active Comparator |
| |
| placebo | Placebo Comparator | mint mini lozenge with no active |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| oral nicotine | Drug | oral nicotine replacement product |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Post-cue Baseline in Nicotine Craving Score at 5 Minutes | 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. | Post-cue baseline,5 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Post-cue Baseline in Nicotine Craving Score at 1 Minute | 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. |
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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 |
|---|---|---|---|---|---|---|
| Los Angeles Clinical Trials | Burbank | California | 91505 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29663982 | Derived | Nides M, Shanga GM, Bishop A, Becker WD. Nicotine Lozenges in the Relief of Behaviorally Provoked Craving. Am J Health Behav. 2018 May 1;42(3):69-80. doi: 10.5993/AJHB.42.3.7. |
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IPD for this study will be made available via the Clinical Study Data Request site.
IPD is available via the Clinical Study Data Request site (click on the link provided below)
Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
Of 423 screened participants, 323 were randomized while 94 did not meet the study criterion and remaining 6 discontinued due to other reasons. All randomized participants had a history of smoking more than 20 cigarettes per day.
Participants were recruited at the clinical site.
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| ID | Title | Description |
|---|---|---|
| FG000 | Nicotine Lozenge 4 Milligrams (mg) | Participants received a single dose of 4 mg nicotine polacrilex mint lozenge, through oral route. |
| FG001 | Matched Placebo | Participants received a single dose of matched placebo mint lozenge, through oral route. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Nicotine Lozenge 4 mg | Participants received a single dose of 4 mg nicotine polacrilex mint lozenge, through oral route. |
| BG001 | Matched Placebo | Participants received a single dose of matched placebo mint lozenge, through oral route. |
| 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 | Change From Post-cue Baseline in Nicotine Craving Score at 5 Minutes | 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. | Intention to Treat (ITT) population: All randomized participants who had at least one cravings assessment measurement post dose. The imputation of missing craving score was based on last observation carried forward (LOCF) technique. | Posted | Least Squares Mean | 95% Confidence Interval | Score on a scale | Post-cue baseline,5 minutes |
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All adverse events encountered or spontaneously reported following administration of any investigational product (including washout product), or for up to 5 days after the last administration of investigational product were recorded.
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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 4 mg | Participants received a single dose of 4 mg nicotine polacrilex mint lozenge, through oral route. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 |
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| ID | Term |
|---|---|
| D012907 | Smoking |
| ID | Term |
|---|---|
| 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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| Placebo |
| Drug |
no active |
|
| Post-cue baseline, 1 minute post treatment administration |
| Change From Post-cue Baseline in Nicotine Craving Score at 3 Minutes | 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. | Post-cue Baseline, 3 minutes post treatment administration |
| Change From Post-cue Baseline in Nicotine Craving Score at 7 Minutes | 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. | Post-Cue Baseline, 7 minutes post treatment administration |
| Change From Post-cue Baseline in Nicotine Craving Score at 10 Minutes | 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. | Post-Cue Baseline, 10 minutes post treatment administration |
| Number of Participants With Adverse Events (AEs), Treatment Related AEs, and Serious AEs (SAEs) | AE was defined as any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with study treatment/s. Treatment related AE was defined as any AE considered to be possibly, probably or highly probably related to study medication. SAE was defined as any untoward medical occurrence that at any dose results in death; is life threatening; requires hospitalization or prolongation of existing hospitalization results in disability/ incapacity; is a congenital anomaly/ birth defect. | Baseline to Day 5 post treatment administration |
| BG002 | Total | Total of all reporting groups |
| Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Body Mass Index | Mean | Standard Deviation | Kilograms (kg)/ meter (m)^2 |
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Participants received a single dose of 4 mg nicotine polacrilex mint lozenge, through oral route.
| OG001 | Matched Placebo | Participants received a single dose of matched placebo mint lozenge, through oral route. |
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| Secondary | Change From Post-cue Baseline in Nicotine Craving Score at 1 Minute | 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. | ITT population: All randomized participants who had at least one cravings assessment measurement post dose. The imputation of missing craving score was based on LOCF technique. | Posted | Least Squares Mean | 95% Confidence Interval | Score on a scale | Post-cue baseline, 1 minute post treatment administration |
|
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|
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| Secondary | Change From Post-cue Baseline in Nicotine Craving Score at 3 Minutes | 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. | ITT population: All randomized participants who had at least one cravings assessment measurement post dose. The imputation of missing craving score was based on LOCF technique. | Posted | Least Squares Mean | 95% Confidence Interval | Score on a scale | Post-cue Baseline, 3 minutes post treatment administration |
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| Secondary | Change From Post-cue Baseline in Nicotine Craving Score at 7 Minutes | 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. | ITT population: All randomized participants who had at least one cravings assessment measurement post dose. The imputation of missing craving score was based on LOCF technique. | Posted | Least Squares Mean | 95% Confidence Interval | Score on a scale | Post-Cue Baseline, 7 minutes post treatment administration |
|
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|
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| Secondary | Change From Post-cue Baseline in Nicotine Craving Score at 10 Minutes | 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. | ITT population: All randomized participants who had at least one cravings assessment measurement post dose. The imputation of missing craving score was based on LOCF technique | Posted | Least Squares Mean | 95% Confidence Interval | Score on a scale | Post-Cue Baseline, 10 minutes post treatment administration |
|
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| Secondary | Number of Participants With Adverse Events (AEs), Treatment Related AEs, and Serious AEs (SAEs) | AE was defined as any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with study treatment/s. Treatment related AE was defined as any AE considered to be possibly, probably or highly probably related to study medication. SAE was defined as any untoward medical occurrence that at any dose results in death; is life threatening; requires hospitalization or prolongation of existing hospitalization results in disability/ incapacity; is a congenital anomaly/ birth defect. | Safety population: All randomized participants who received the study treatments were considered evaluable for safety. | Posted | Number | Participants | Baseline to Day 5 post treatment administration |
|
|
|
| 0 |
| 162 |
| 54 |
| 162 |
| EG001 | Placebo Lozenge | Participants received a single dose of matched placebo mint lozenge, through oral route. | 0 | 161 | 12 | 161 |
| Dyspepsia | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
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| Abdominal Discomfort | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
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| Stomatitis | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
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| Glossodynia | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
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| Flatulence | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
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| Oral Discomfort | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
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| Hiccups | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | Systematic Assessment |
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| Throat Irritation | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | Systematic Assessment |
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| Nasal Congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | Systematic Assessment |
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| Oropharyngeal Pain | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA 14.1 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 14.1 | Systematic Assessment |
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| Heart Rate Increased | Investigations | MedDRA 14.1 | Systematic Assessment |
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| Anxiety | Psychiatric disorders | MedDRA 14.1 | Systematic Assessment |
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| Ear Pain | Ear and labyrinth disorders | MedDRA 14.1 | 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 |
| SAEs |
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