Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2008-006279-65 | EudraCT Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
A comparison of three products for oral nicotine replacement with respect to pharmacokinetics after multiple-doses of nicotine.
This study compares a new oral Nicotine Replacement Therapy (NRT) product with NiQuitin™ lozenge 4 mg and Nicorette®gum 4 mg, after 12 hours of nicotine abstinence, with respect to steady-state nicotine pharmacokinetics, during 12 hours after start of the first administration. Multiple doses of each treatment are given once hourly during five separate treatment visits scheduled in a crossover setting with randomized treatment sequences. The study will include 40 healthy smokers between 18-50 years, who have been smoking at least 20 cigarettes daily during at least one year preceding inclusion. Subjects and study personnel will be aware of which treatment is administered at a given visit.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oral Nicotine 24-SA | Experimental | 2 Self-administrations of Experimental Nicotine once every hour |
|
| Oral Nicotine 24 | Experimental | 2 administrations of Experimental Nicotine by study personnel once every hour |
|
| Oral Nicotine 48 | Experimental | 2 administrations of Experimental Nicotine by study personnel once every 30 minutes |
|
| NiQuitin™ Lozenge 4 mg | Active Comparator | 1 NiQuitin™ lozenge, administered by study personnel once every hour |
|
| Nicorette® Gum 4 mg | Active Comparator | 1 piece Nicorette® gum, chewed for 30 minutes once every hour |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oral Nicotine | Drug | Oral Nicotine either self-administered or provided by study personnel within 12 hours |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Plasma Concentration | Cmax, which is the maximum (peak) concentration (amount of drug) measurable in blood plasma after a dose is administered measured in nanograms/milliliter (ng/ml) | During the last dosing interval (hour 11-12 post-dose) |
| Average Concentration | Pharmacokinetic measurement - average concentration during the last dosing interval (AUCtau) | During the last dosing interval (hour 11-12 post-dose) |
| Measure | Description | Time Frame |
|---|---|---|
| Time of Maximum Concentration | The time at which maximum concentration is reached (Tmax) | During the last dosing interval (hour 11-12 post-dose) |
| Minimum Plasma Concentration | The minimum nicotine plasma concentration during the last dosing interval (Cmin) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Elisabeth Kruse, PhD | McNeil AB | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Pharmacology | Lund | 222 20 | Sweden |
Not provided
This was a five-arm cross-over trial, with subjects randomized to the order they received the different treatments and with analysis performed on valid pharmacokinetic data. Therefore, Number of Participants Analyzed in each arm represents the same subjects, and the total is not consistent with numbers provided in the participant flow module.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Overall Study | All subjects randomized into the trial |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | All Randomized Subjects | All subjects randomized into the trial, e.g., Full Analysis Set |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Maximum Plasma Concentration | Cmax, which is the maximum (peak) concentration (amount of drug) measurable in blood plasma after a dose is administered measured in nanograms/milliliter (ng/ml) | Posted | Geometric Mean | Standard Deviation | (ng/ml) | During the last dosing interval (hour 11-12 post-dose) |
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Oral Nicotine 24-SA | Oral Nicotine 24 mg, 2 1mg self-administrations once every hour; 12 doses of 2 mg over 11 hours |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal distension | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment | Total number of subjects affected in the safety analysis set in arms where the data lies above the 5% threshold |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Joyce Hauze, Sr. Specialist, Clinical Research Operations | J&J Consumer and Personal Products Worldwide | 928-277-0715 | jhauze@its.jnj.com |
Not provided
| ID | Term |
|---|---|
| D014029 | Tobacco Use Disorder |
| D016540 | Smoking Cessation |
| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
| D015438 | Health Behavior |
Not provided
Not provided
| ID | Term |
|---|---|
| D009538 | Nicotine |
| D061485 | Tobacco Use Cessation Devices |
| D000074164 | Nicotine Chewing Gum |
| ID | Term |
|---|---|
| D012991 | Solanaceous Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D011725 | Pyridines |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Nicotine Lozenge | Drug | Nicotine lozenge marketed as NiQuitin™ 4 mg hourly within 12 hours |
|
|
| Nicotine gum | Drug | Nicotine gum marketed as Nicorette® 4 mg hourly within 12 hours |
|
|
| During the last dosing interval (hour 11-12 post-dose) |
| Peak-Trough Fluctuation | Percent of peak-trough fluctuation over one dosing interval at steady state (PTF) | During the last dosing interval (hour 11-12 post-dose) |
| Nicotine Plasma Concentration | The nicotine concentration in plasma (area under the nicotine plasma concentration curve) 1 hour after start of treatment | One hour after start of treatment |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Oral Nicotine 48 |
Oral Nicotine 48 mg, 2 1mg administrations by study personnel once every 30 minutes; 24 doses of 2 mg over 11.5 hours |
| OG003 | NiQuitin™ Lozenge 4 mg | NiQuitin™ lozenge 4 mg; 12 doses of NiQuitin™ lozenge 4 mg over 11 hours |
| OG004 | Nicorette® Gum 4 mg | 12 doses of NICORETTE® gum 4 mg over 11 hours |
|
|
| Secondary | Time of Maximum Concentration | The time at which maximum concentration is reached (Tmax) | ITT | Posted | Median | Full Range | (minutes) | During the last dosing interval (hour 11-12 post-dose) |
|
|
|
| Secondary | Minimum Plasma Concentration | The minimum nicotine plasma concentration during the last dosing interval (Cmin) | ITT | Posted | Mean | Standard Deviation | (ng/ml) | During the last dosing interval (hour 11-12 post-dose) |
|
|
|
| Secondary | Peak-Trough Fluctuation | Percent of peak-trough fluctuation over one dosing interval at steady state (PTF) | ITT | Posted | Mean | Standard Deviation | Percent Fluctuation | During the last dosing interval (hour 11-12 post-dose) |
|
|
|
| Secondary | Nicotine Plasma Concentration | The nicotine concentration in plasma (area under the nicotine plasma concentration curve) 1 hour after start of treatment | ITT | Posted | Geometric Mean | Standard Deviation | (ng/ml) | One hour after start of treatment |
|
|
|
| Primary | Average Concentration | Pharmacokinetic measurement - average concentration during the last dosing interval (AUCtau) | ITT | Posted | Geometric Mean | Standard Deviation | (ng/ml) | During the last dosing interval (hour 11-12 post-dose) |
|
|
|
| 0 |
| 40 |
| 29 |
| 40 |
| EG001 | Oral Nicotine 24 | Oral Nicotine 24 mg, 2 1mg administrations by study personnel once every hour; 12 doses of 2 mg over 11 hours | 0 | 37 | 22 | 37 |
| EG002 | Oral Nicotine 48 | Oral Nicotine 48 mg, 2 1mg administrations by study personnel once every 30 minutes; 24 doses of 2 mg over 11.5 hours | 0 | 36 | 27 | 36 |
| EG003 | NiQuitin™ Lozenge 4 mg | NiQuitin™ lozenge 4 mg; 12 doses of NiQuitin™ lozenge 4 mg over 11 hours | 0 | 35 | 24 | 35 |
| EG004 | Nicorette® Gum 4 mg | 12 doses of NICORETTE® gum 4 mg over 11 hours | 0 | 35 | 18 | 35 |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment | Total number of subjects affected in the safety analysis set in arms where the data lies above the 5% threshold |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment | Total number of subjects affected in the safety analysis set in arms where the data lies above the 5% threshold |
|
| Eructation | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment | Total number of subjects affected in the safety analysis set in arms where the data lies above the 5% threshold |
|
| Nausea | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment | Total number of subjects affected in the safety analysis set in arms where the data lies above the 5% threshold |
|
| Salivary hypersecretion | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment | Total number of subjects affected in the safety analysis set in arms where the data lies above the 5% threshold |
|
| Nasopharyngitis | Infections and infestations | MedDRA 12.1 | Systematic Assessment | Total number of subjects affected in the safety analysis set in arms where the data lies above the 5% threshold |
|
| Headache | Nervous system disorders | MedDRA 12.1 | Systematic Assessment | Total number of subjects affected in the safety analysis set in arms where the data lies above the 5% threshold |
|
| Hiccups | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | Systematic Assessment | Total number of subjects affected in the safety analysis set in arms where the data lies above the 5% threshold |
|
| Throat irritation | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | Systematic Assessment | Total number of subjects affected in the safety analysis set in arms where the data lies above the 5% threshold |
|
| Throat tightness | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Lacrimation Increase | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Diarrheoa | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Flatulence | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Glossodynia | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
|
| Dysmenorrhoea | Reproductive system and breast disorders | MedDRA 12.1 | Systematic Assessment |
|
| Oropharyngial Pain | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
|
Not provided
Not provided
Not provided
| D001519 | Behavior |
| D006573 |
| Heterocyclic Compounds, 1-Ring |
| D013812 | Therapeutics |
| D002638 | Chewing Gum |
| D053149 | Plant Gums |
| D001704 | Biopolymers |
| D011108 | Polymers |
| D046911 | Macromolecular Substances |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
| D002182 | Candy |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |