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NCT00139750 Clinical Trial

12 Week Evaluation of the Safety and Efficacy of 3 Doses of CP-526,555 and Placebo for Smoking Cessation

Smoking Cessation Clinical Trial

Official title:
A Double-Blind, Placebo-Controlled, Randomized, Multicenter Study Evaluating The Efficacy And Safety Of CP-526,555 In Smokers Motivated To Stop Smoking

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00139750
Other study ID # A3051046
Secondary ID
Status Completed
Phase Phase 2
First received August 29, 2005
Last updated June 1, 2007
Start date December 2004
Est. completion date February 2006

Study information
Verified date June 2007
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority Japan: Ministry of Health, Labor and Welfare
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 600
Est. completion date February 2006
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 20 Years to 75 Years
Eligibility 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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• CP-526,555 (varenicline)

Locations
Country Name City State
Japan Pfizer Investigational Site Beppu-shi Oita-ken
Japan Pfizer Investigational Site Edogawa-ku Tokyo
Japan Pfizer Investigational Site Fukuoka
Japan Pfizer Investigational Site Hamamatsu Shizuoka
Japan Pfizer Investigational Site Minato-ku Tokyo
Japan Pfizer Investigational Site Musashino Tokyo
Japan Pfizer Investigational Site Noda Chiba
Japan Pfizer Investigational Site Ohita
Japan Pfizer Investigational Site Sapporo Hokkaido
Japan Pfizer Investigational Site Setagaya-ku Tokyo
Japan Pfizer Investigational Site Shinagawa-ku Tokyo
Japan Pfizer Investigational Site Toshima-ku Tokyo
Japan Pfizer Investigational Site Tosu Saga
Japan Pfizer Investigational Site Toyonaka Osaka
Japan Pfizer Investigational Site Yokohama Kanagawa

Sponsors (1)
Lead Sponsor Collaborator
Pfizer

Country where clinical trial is conducted

Japan, 

Outcome
Type Measure Description Time frame Safety issue
Primary 4-week continuous quit rate (CQR) for Weeks 9-12
Secondary Continuous abstinence for Weeks 9-52 and Weeks 9-24
Secondary Long-term quit rate at Week 52
Secondary 4-week CQR for Weeks 4-7
Secondary 7-day point prevalence of asbtinence Weeks 12, Week 24, and Week 52
Secondary Continuous abstinence from TQD (Week 1) through Week 12
Secondary Weekly average number of cigarettes smoked per day for Weeks 1-12
Secondary Evaluation of withdrawal symptoms by the Minnesota Nicotine Withdrawal Scale
Secondary Evaluation of smoking satisfaction by the Smoking Effects Inventory
Secondary Evaluation of urge to smoke by the Brief Questionnaire of Smoking Urges
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