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Completed

NCT Number: NCT00635401

A Study of 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.

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Key information

Conditions

Smoking Behavior

Age range

20 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Pfizer Investigational Site, Chuo-ku Fukuoka, Fukuoka, Japan

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Varenicline

Drug

0.5 mg BID for 7 weeks

Other names: Chantix, Champix, CP-526,555

Primary outcomes

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

    Time frame: Weeks 4-7

Secondary outcomes

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

    Time frame: Weeks 2-7

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

    Time frame: Weeks 2-7

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

    Time frame: Weeks 2-7

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

    Time frame: Weeks 2-7

  5. 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

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

    Time frame: Weeks 2-7

  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

  8. Adverse events, laboratory test changes throughout the study.

    Time frame: Weeks 1-7

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

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

Important dates

Study start
2004
Study completion
2004
First posted
Mar 13, 2008
Registry last updated
Apr 10, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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