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To evaluate the safety, smoking cessation and reduction rate during 3 months of active nicotine replacement therapy (NRT) and a follow-up period of 3 months in smoking hospital physicians and staff who are motivated to quit
Using Nicorette® gum 2 mg, 4 mg and Nicorette® patch 5 mg/16 h, 10 mg/16 h, 15 mg/16 h to alleviate nicotine cravings and withdrawal symptoms and assist smoking cessation in smoking hospital physicians and staff who are motivated to quit. During the study, brief telephone consultation and SMS are provided as behavioral supports.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Gum 2 | Experimental | Nicotine Gum 2 mg for subjects smoking less than 20 cigarettes per day; 2 mg for 12 week treatments and followed by 12 week off-treatment follow-up. Recommend subject to use 8-12 pieces daily for first 8 weeks and 4-6 pieces daily the next 2 weeks, then reduce to 1-3 pieces each day in last 2 weeks |
|
| Gum 4 | Experimental | Nicotine Gum 4 mg for subjects smoking 20 or more cigarettes per day; 4 mg for 12 week treatments and followed by 12 week off-treatment follow-up. Recommend subject to use 8-12 pieces daily for first 8 weeks and 4-6 pieces daily the next 2 weeks, then reduce to 1-3 pieces each day in last 2 weeks |
|
| Patch | Experimental | Nicotine Patch; Each will use 15 mg/16 h patch for the first 8 weeks, 10 mg/16 h for the following 2 weeks and 5 mg/16 h for the last 2 weeks. Then followed by 12 week off-treatment follow-up. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nicotine Gum | Drug | 2 mg or 4 mg for 12 week treatments and followed by 12 week off-treatment follow-up. Recommend subject to use 8-12 pieces daily for first 8 weeks and 4-6 pieces daily the next 2 weeks, then reduce to 1-3 pieces each day in last 2 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment-Related Adverse Events | Percentage of subjects with treatment-related adverse events by preferred term, included if the percentage in any single arm was 1% or higher | 24 Weeks |
| Self-Reported Smoking Reduction | Percentage of subjects self-reporting reduction from baseline in number of cigarettes smoked per day | 24 Weeks |
| Smoking Abstinence | Continuous carbon monoxide (CO)-verified Smoking Abstinence from Quit day | 24 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Carbon Monoxide (CO)-Verified Smoking Reduction | Percentage of participants with carbon monoxide (CO)-verified reduction from baseline in number of cigarettes smoked per day (%) | Baseline to Week 24 |
| Smoking Consumption Per Day |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jackie Mao | Shanghai Johnson & Johnson Pharmaceuticals | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing ChaoYang Hospital | Beijing | Beijing Municipality | 100043 | China | ||
| People's Hospital affiliated to Beijing University |
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| ID | Title | Description |
|---|---|---|
| FG000 | Nicotine Gum 2 | Dosage: 2 mg, Dosage Form: Gum |
| FG001 | Nicotine Gum 4 | Dosage: 4 mg, Dosage Form: Gum |
| FG002 | Nicotine Patch | Dosage: Step-down treatment 15 mg,10 mg, then 5 mg/16 hours Dosage Form: Patch |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Nicotine Gum 2 | Dosage: 2 mg, Dosage Form: Gum |
| BG001 | Nicotine Gum 4 | Dosage: 4 mg, Dosage Form: Gum |
| Units | Counts |
|---|---|
| Participants |
|
| 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 | Treatment-Related Adverse Events | Percentage of subjects with treatment-related adverse events by preferred term, included if the percentage in any single arm was 1% or higher | Safety Analysis Set (ITT) | Posted | Number | Percentage of Participants | 24 Weeks |
|
24 Weeks
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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 Gum 2 | Dosage: 2 mg, Dosage Form: Gum |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Sinus tachycardia | Cardiac disorders | MedDRA (12.0) | Systematic Assessment |
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| 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 |
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| 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 |
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| ID | Term |
|---|---|
| D000074164 | Nicotine Chewing Gum |
| D061485 | Tobacco Use Cessation Devices |
| ID | Term |
|---|---|
| D002638 | Chewing Gum |
| D053149 | Plant Gums |
| D001704 | Biopolymers |
| D011108 | Polymers |
| D046911 |
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| Nicotine Patch | Drug | Each will use 15 mg/16 h patch for the first 8 weeks, 10 mg/16 h for the following 2 weeks and 5 mg/16 h for the last 2 weeks. Then followed by 12 week off-treatment follow-up. |
|
|
Number of cigarettes smoked by subjects reporting smoking since last visit - total during the day (for daily smokers)
| 24 Weeks from last visit: |
| Smoking Consumption Per Week | Number of cigarettes smoked by subjects reporting smoking since last visit - total during the the week (for non-daily smokers) | 24 Weeks from last visit: |
| Point Prevalence Smoking Abstinence (PPSA) | Point Prevalence Smoking Abstinence since last visit. Point prevalence abstinence is defined as the percentage of former smokers who are not smoking at a particular point in time, typically at the time of assessment. | 24 Weeks |
| Beijing |
| Beijing Municipality |
| 100044 |
| China |
| No. 1 Hospital affiliated to Zhongshan University | Guangzhou | Guangdong | 510080 | China |
| No. 1 Hospital affiliated to Guangzhou Medical University | Guangzhou | Guangdong | 510120 | China |
| Chang Zheng Hospital | Shanghai | Shanghai Municipality | 200003 | China |
| Zhong Shan Hospital affiliated to Fudan University | Shanghai | Shanghai Municipality | 200032 | China |
| BG002 |
| Nicotine Patch |
Dosage: Step-down treatment 15 mg,10 mg, then 5 mg/16 hours Dosage Form: Patch |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Dosage: Step-down treatment 15 mg,10 mg, then 5 mg/16 hours Dosage Form: Patch
|
|
| Primary | Self-Reported Smoking Reduction | Percentage of subjects self-reporting reduction from baseline in number of cigarettes smoked per day | Posted | Mean | Standard Deviation | Percentage of Participants | 24 Weeks |
|
|
|
| Secondary | Carbon Monoxide (CO)-Verified Smoking Reduction | Percentage of participants with carbon monoxide (CO)-verified reduction from baseline in number of cigarettes smoked per day (%) | Posted | Mean | Standard Deviation | Percentage of Participants | Baseline to Week 24 |
|
|
|
| Secondary | Smoking Consumption Per Day | Number of cigarettes smoked by subjects reporting smoking since last visit - total during the day (for daily smokers) | Posted | Mean | Standard Deviation | Cigarettes | 24 Weeks from last visit: |
|
|
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| Secondary | Smoking Consumption Per Week | Number of cigarettes smoked by subjects reporting smoking since last visit - total during the the week (for non-daily smokers) | Posted | Mean | Standard Deviation | Cigarettes | 24 Weeks from last visit: |
|
|
|
| Primary | Smoking Abstinence | Continuous carbon monoxide (CO)-verified Smoking Abstinence from Quit day | Posted | Number | Participants | 24 Weeks |
|
|
|
| Secondary | Point Prevalence Smoking Abstinence (PPSA) | Point Prevalence Smoking Abstinence since last visit. Point prevalence abstinence is defined as the percentage of former smokers who are not smoking at a particular point in time, typically at the time of assessment. | Posted | Number | Participants | 24 Weeks |
|
|
|
| 0 |
| 86 |
| 22 |
| 86 |
| EG001 | Nicotine Gum 4 | Dosage: 4 mg, Dosage Form: Gum | 0 | 64 | 26 | 64 |
| EG002 | Nicotine Patch | Dosage: Step-down treatment 15 mg,10 mg, then 5 mg/16 hours Dosage Form: Patch | 0 | 150 | 33 | 150 |
| Abdominal distension | Gastrointestinal disorders | MedDRA (12.0) | Systematic Assessment |
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| Abdominal pain upper | Gastrointestinal disorders | MedDRA (12.0) | Systematic Assessment |
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| Abdominal symptom | Gastrointestinal disorders | MedDRA (12.0) | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA (12.0) | Systematic Assessment |
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| Dyspepsia | Gastrointestinal disorders | MedDRA (12.0) | Systematic Assessment |
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| Eructation | Gastrointestinal disorders | MedDRA (12.0) | Systematic Assessment |
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| Gingival ulceration | Gastrointestinal disorders | MedDRA (12.0) | Systematic Assessment |
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| Mouth ulceration | Gastrointestinal disorders | MedDRA (12.0) | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA (12.0) | Systematic Assessment |
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| Oral discomfort | Gastrointestinal disorders | MedDRA (12.0) | Systematic Assessment |
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| Retching | Gastrointestinal disorders | MedDRA (12.0) | Systematic Assessment |
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| Chest discomfort | General disorders | MedDRA (12.0) | Systematic Assessment |
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| Heart rate increased | Investigations | MedDRA (12.0) | Systematic Assessment |
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| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (12.0) | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA (12.0) | Systematic Assessment |
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| Insomnia | Psychiatric disorders | MedDRA (12.0) | Systematic Assessment |
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| Hiccups | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | Systematic Assessment |
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| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | Systematic Assessment |
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| Tachypnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | Systematic Assessment |
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| Dermatitis allergic | Skin and subcutaneous tissue disorders | MedDRA (12.0) | Systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (12.0) | Systematic Assessment |
|
| Rash vesicular | Skin and subcutaneous tissue disorders | MedDRA (12.0) | Systematic Assessment |
|
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| D001519 | Behavior |
| Macromolecular Substances |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
| D013812 | Therapeutics |
| D002182 | Candy |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |
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