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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00635401

Enrollment

Registered

2008-03-13

Start date

2004-05-31

Completion date

2004-08-31

Last updated

2008-04-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Smoking

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.

Interventions

DRUGVarenicline

0.5 mg BID for 7 weeks

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to 75 Years

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
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
CO-confirmed 7-day Point Prevalence 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
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

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026