A Study of the Efficacy and Safety of Varenicline in Japanese Smokers Motivated to Quit Smoking
- Registration Number
- NCT00635401
- Lead Sponsor
- Pfizer
- Brief Summary
The purpose of this study is to evaluate the efficacy and safety of varenicline in Japanese smokers. Efficacy is evaluated by continuous quit rate and withdrawal symptoms of smokers. Safety is evaluated by adverse events, laboratory tests, and other safety tests.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 30
Inclusion Criteria
- Japanese smokers motivated to quit smoking
- No period without smoking of more than 3 months
- Smoked an average of at least 10 cigarettes/day in the past year
Exclusion Criteria
- Subjects who have used nicotine replacement therapy within 1 month of the study screening visit
- Subjects intending to use nicotine replacement therapy or other smoking cessation treatments during the study
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 0.5 mg BID Varenicline -
- Primary Outcome Measures
Name Time Method Carbon monoxide (CO)-confirmed 4-week continuous quit rate (4-week CQR) from Weeks 4 to 7. Weeks 4-7
- Secondary Outcome Measures
Name Time Method CO-confirmed 7-day Point Prevalence from Week 2 through Week 7. Weeks 2-7 Continuous abstinence rate from target quit date (TQD) from Week 2 through Week 7. Weeks 2-7 Average number of daily cigarettes smoked from Week 2 through Week 7. Weeks 2-7 Assessment of withdrawal symptoms by Minnesota Nicotine Withdrawal Scales (MNWS) from Week 2 through Week 7. Weeks 2-7 Assessment of satisfaction (desirable and aversive effects) obtained from smoking by Smoking Effects Inventory (SEI) (administered only to subjects who had smoked since the previous assessment) from Week 2 through Week 7. Weeks 2-7 Assessment of tobacco craving by the Brief Questionnaire of Smoking Urges (QSU-Brief) from Week 2 through Week 7. Weeks 2-7 Assessment of the effect of smoking cessation on subjects' quality of life by the Smoking Cessation Quality of Life (SCQoL) questionnaire from Week 2 through Week 7. Weeks 2-7 Adverse events, laboratory test changes throughout the study. Weeks 1-7
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What are the molecular mechanisms by which varenicline modulates nicotinic acetylcholine receptors to reduce nicotine cravings in Japanese smokers?
How does varenicline's efficacy in Japanese smokers compare to standard-of-care treatments like bupropion or nicotine replacement therapy in phase 2 trials?
Which biomarkers could predict response to varenicline in nicotine-dependent individuals with specific genetic or metabolic profiles?
What are the most common adverse events associated with varenicline treatment in Asian populations and how are they managed clinically?
How does varenicline's pharmacokinetic profile in Japanese patients influence its effectiveness compared to other smoking cessation drugs like cytisine or varenicline analogs?
Trial Locations
- Locations (1)
Pfizer Investigational Site
🇯🇵Oita, Japan
Pfizer Investigational Site🇯🇵Oita, Japan