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

April 7, 2008 updated by: Pfizer

A Multicenter, Open-Label Study Exploring the Efficacy and Safety of Varenicline in Japanese Smokers Motivated to Quit Smoking

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Oita, Japan
        • Pfizer Investigational Site
    • Fukuoka
      • Chuo-ku Fukuoka, Fukuoka, Japan
        • Pfizer Investigational Site
    • Kanagawa
      • Nishi-ku Yokohama, Kanagawa, Japan
        • Pfizer Investigational Site
    • Oita
      • Beppu, Oita, Japan
        • Pfizer Investigational Site
    • Shizuoka-ken
      • Hamamatsu-shi, Shizuoka-ken, Japan
        • Pfizer Investigational Site
    • Tokyo
      • Edogawa-ku, Tokyo, Japan
        • Pfizer Investigational Site
      • Minato-ku, Tokyo, Japan
        • Pfizer Investigational Site
      • Toshima-ku, Tokyo, Japan
        • Pfizer Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 0.5 mg BID
Drug: Varenicline
0.5 mg BID for 7 weeks
Other Names:
  • Chantix, Champix, CP-526,555

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
CO-confirmed 7-day Point Prevalence from Week 2 through Week 7.
Time Frame: Weeks 2-7
Weeks 2-7
Continuous abstinence rate from target quit date (TQD) from Week 2 through Week 7.
Time Frame: Weeks 2-7
Weeks 2-7
Average number of daily cigarettes smoked from Week 2 through Week 7.
Time Frame: Weeks 2-7
Weeks 2-7
Assessment of withdrawal symptoms by Minnesota Nicotine Withdrawal Scales (MNWS) from Week 2 through Week 7.
Time Frame: Weeks 2-7
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.
Time Frame: Weeks 2-7
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
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
Weeks 2-7
Adverse events, laboratory test changes throughout the study.
Time Frame: Weeks 1-7
Weeks 1-7

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2004

Study Completion (Actual)

August 1, 2004

Study Registration Dates

First Submitted

March 5, 2008

First Submitted That Met QC Criteria

March 5, 2008

First Posted (Estimate)

March 13, 2008

Study Record Updates

Last Update Posted (Estimate)

April 10, 2008

Last Update Submitted That Met QC Criteria

April 7, 2008

Last Verified

April 1, 2008

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A3051043

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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