A Study of the Efficacy and Safety of Varenicline in Japanese Smokers Motivated to Quit Smoking
A Multicenter, Open-Label Study Exploring the Efficacy and Safety of Varenicline in Japanese Smokers Motivated to Quit Smoking
1 other identifier
interventional
30
1 country
8
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started May 2004
Shorter than P25 for phase_2
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2004
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2004
CompletedFirst Submitted
Initial submission to the registry
March 5, 2008
CompletedFirst Posted
Study publicly available on registry
March 13, 2008
CompletedApril 10, 2008
April 1, 2008
March 5, 2008
April 7, 2008
Conditions
Outcome Measures
Primary Outcomes (1)
Carbon monoxide (CO)-confirmed 4-week continuous quit rate (4-week CQR) from Weeks 4 to 7.
Weeks 4-7
Secondary Outcomes (8)
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
- +3 more secondary outcomes
Study Arms (1)
0.5 mg BID
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (8)
Pfizer Investigational Site
Chuo-ku Fukuoka, Fukuoka, Japan
Pfizer Investigational Site
Nishi-ku Yokohama, Kanagawa, Japan
Pfizer Investigational Site
Beppu, Oita Prefecture, Japan
Pfizer Investigational Site
Ōita, Oita Prefecture, Japan
Pfizer Investigational Site
Hamamatsu, Shizuoka, Japan
Pfizer Investigational Site
Edogawa-ku, Tokyo, Japan
Pfizer Investigational Site
Minato-ku, Tokyo, Japan
Pfizer Investigational Site
Toshima-ku, Tokyo, Japan
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
March 5, 2008
First Posted
March 13, 2008
Study Start
May 1, 2004
Study Completion
August 1, 2004
Last Updated
April 10, 2008
Record last verified: 2008-04