A Study of the Efficacy and Safety of Varenicline in Japanese Smokers Motivated to Quit Smoking

Phase 2

Completed

• Conditions: Smoking
• Interventions: Drug: Varenicline

• Registration Number: NCT00635401
• Lead Sponsor: Pfizer

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-05
• Study Completion: 2004-08
• Study First Submitted: 2008-03-05
• Study First Submitted QC: 2008-03-05
• Study First Posted: 2008-03-13
• Status Verified: 2008-04
• Last Update Submitted: 2008-04-07
• Last Update Posted: 2008-04-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• 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

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
0.5 mg BID	Varenicline	-

Primary Outcome Measures

Name	Time	Method
Carbon monoxide (CO)-confirmed 4-week continuous quit rate (4-week CQR) from Weeks 4 to 7.	Weeks 4-7

Secondary Outcome Measures

Name	Time	Method
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
Assessment of tobacco craving by the Brief Questionnaire of Smoking Urges (QSU-Brief) from Week 2 through Week 7.	Weeks 2-7
Assessment of the effect of smoking cessation on subjects' quality of life by the Smoking Cessation Quality of Life (SCQoL) questionnaire from Week 2 through Week 7.	Weeks 2-7
Adverse events, laboratory test changes throughout the study.	Weeks 1-7

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇯🇵 Oita, Japan