NCT00139750CompletedPhase 2
A Double-Blind, Placebo-Controlled, Randomized, Multicenter Study Evaluating The Efficacy And Safety Of CP-526,555 In Smokers Motivated To Stop Smoking
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Pfizer
- Enrollment
- 600
- Locations
- 15
- Primary Endpoint
- 4-week continuous quit rate (CQR) for Weeks 9-12
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double
Eligibility Criteria
- Ages
- 20 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
4-week continuous quit rate (CQR) for Weeks 9-12
Secondary Outcomes
- 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
Investigators
Study Sites (15)
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