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

Pfizer30 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Smoking

Interventions

VareniclineDRUG

0.5 mg BID for 7 weeks

Eligibility

Sex: ALLMin age: 20 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (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

Outcomes

Primary Outcomes

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

Time frame: Weeks 4-7

Secondary Outcomes

CO-confirmed 7-day Point Prevalence from Week 2 through Week 7.

Time frame: Weeks 2-7

Continuous abstinence rate from target quit date (TQD) from Week 2 through Week 7.

Time frame: Weeks 2-7

Average number of daily cigarettes smoked from Week 2 through Week 7.

Time frame: Weeks 2-7

Assessment of withdrawal symptoms by Minnesota Nicotine Withdrawal Scales (MNWS) from Week 2 through Week 7.

Time frame: 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.

Time frame: Weeks 2-7

Assessment of tobacco craving by the Brief Questionnaire of Smoking Urges (QSU-Brief) from Week 2 through Week 7.

Time frame: 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.

Time frame: Weeks 2-7

Adverse events, laboratory test changes throughout the study.

Time frame: Weeks 1-7

Data from ClinicalTrials.gov

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