12 Week Evaluation of the Safety and Efficacy of 3 Doses of CP-526,555 and Placebo for Smoking Cessation
Phase 2
Completed
- Conditions
- Smoking Cessation
- Registration Number
- NCT00139750
- Lead Sponsor
- Pfizer
- Brief Summary
The purpose of the study is to examine the safety and efficacy and dose-response relationship of three doses of CP-526,555 for 12 weeks compared with placebo for smoking cessation; including post-treatment follow-up of smoking status to one year from randomization. A small satellite protocol (A3051048) investigated safety of a second course of therapy in subjects who did not quit.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 600
Inclusion Criteria
- Cigarette smokers who are motivated to stop smoking and have smoked an average of at least 10 cigarettes per day
Exclusion Criteria
- Subjects who have used a nicotine replacement product within 30 days of the study screening visit or intend to use it during the study.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method 4-week continuous quit rate (CQR) for Weeks 9-12
- Secondary Outcome Measures
Name Time Method Continuous abstinence for Weeks 9-52 and Weeks 9-24 Long-term quit rate at Week 52 4-week CQR for Weeks 4-7 7-day point prevalence of asbtinence Weeks 12, Week 24, and Week 52 Continuous abstinence from TQD (Week 1) through Week 12 Weekly average number of cigarettes smoked per day for Weeks 1-12 Evaluation of withdrawal symptoms by the Minnesota Nicotine Withdrawal Scale Evaluation of smoking satisfaction by the Smoking Effects Inventory Evaluation of urge to smoke by the Brief Questionnaire of Smoking Urges
Trial Locations
- Locations (1)
Pfizer Investigational Site
🇯🇵Ohita, Japan