Clinical trial NCT00139750: 12 Week Evaluation of the Safety and Efficacy of 3 Doses of CP-526,555 and Placebo for Smoking Cessation
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Smoking Cessation
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2005-08-31
Enrollment: 600
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: 4-week continuous quit rate (CQR) for Weeks 9-12
Secondary outcomes:
measure: Continuous abstinence for Weeks 9-52 and Weeks 9-24
measure: Long-term quit rate at Week 52
measure: 4-week CQR for Weeks 4-7
measure: 7-day point prevalence of asbtinence Weeks 12, Week 24, and Week 52
measure: Continuous abstinence from TQD (Week 1) through Week 12
measure: Weekly average number of cigarettes smoked per day for Weeks 1-12
measure: Evaluation of withdrawal symptoms by the Minnesota Nicotine Withdrawal Scale
measure: Evaluation of smoking satisfaction by the Smoking Effects Inventory
measure: Evaluation of urge to smoke by the Brief Questionnaire of Smoking Urges
Other outcomes:
Locations:
city: Noda
country: Japan
facility: Pfizer Investigational Site
state: Chiba
city: Sapporo
country: Japan
facility: Pfizer Investigational Site
state: Hokkaido
city: Yokohama
country: Japan
facility: Pfizer Investigational Site
state: Kanagawa
city: Beppu-shi
country: Japan
facility: Pfizer Investigational Site
state: Oita-ken
city: Toyonaka
country: Japan
facility: Pfizer Investigational Site
state: Osaka
city: Tosu
country: Japan
facility: Pfizer Investigational Site
state: Saga
city: Hamamatsu
country: Japan
facility: Pfizer Investigational Site
state: Shizuoka
city: Edogawa-ku
country: Japan
facility: Pfizer Investigational Site
state: Tokyo
city: Minato-ku
country: Japan
facility: Pfizer Investigational Site
state: Tokyo
city: Musashino
country: Japan
facility: Pfizer Investigational Site
state: Tokyo
city: Setagaya-ku
country: Japan
facility: Pfizer Investigational Site
state: Tokyo
city: Shinagawa-ku
country: Japan
facility: Pfizer Investigational Site
state: Tokyo
city: Toshima-ku
country: Japan
facility: Pfizer Investigational Site
state: Tokyo
city: Fukuoka
country: Japan
facility: Pfizer Investigational Site
city: Ohita
country: Japan
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: Nakamura M, Oshima A, Ohkura M, Arteaga C, Suwa K. Predictors of lapse and relapse to smoking in successful quitters in a varenicline post hoc analysis in Japanese smokers. Clin Ther. 2014 Jun 1;36(6):918-27. doi: 10.1016/j.clinthera.2014.03.013. Epub 2014 May 5.
citation: Nakamura M, Oshima A, Fujimoto Y, Maruyama N, Ishibashi T, Reeves KR. Efficacy and tolerability of varenicline, an alpha4beta2 nicotinic acetylcholine receptor partial agonist, in a 12-week, randomized, placebo-controlled, dose-response study with 40-week follow-up for smoking cessation in Japanese smokers. Clin Ther. 2007 Jun;29(6):1040-56. doi: 10.1016/j.clinthera.2007.06.012.