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

Smoking Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00635401
• Other study ID #: A3051043
• Status: Completed
• Phase: Phase 2
• First received: March 5, 2008
• Last updated: April 7, 2008
• Start date: May 2004
• Est. completion date: August 2004

Study information

• Verified date: April 2008
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: August 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 75 Years

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Smoking

Intervention

Drug:
• Varenicline
0.5 mg BID for 7 weeks

Locations

Country	Name	City	State
Japan	Pfizer Investigational Site	Beppu	Oita
Japan	Pfizer Investigational Site	Chuo-ku Fukuoka	Fukuoka
Japan	Pfizer Investigational Site	Edogawa-ku	Tokyo
Japan	Pfizer Investigational Site	Hamamatsu-shi	Shizuoka-ken
Japan	Pfizer Investigational Site	Minato-ku	Tokyo
Japan	Pfizer Investigational Site	Nishi-ku Yokohama	Kanagawa
Japan	Pfizer Investigational Site	Oita
Japan	Pfizer Investigational Site	Toshima-ku	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Carbon monoxide (CO)-confirmed 4-week continuous quit rate (4-week CQR) from Weeks 4 to 7.		Weeks 4-7	No
Secondary	CO-confirmed 7-day Point Prevalence from Week 2 through Week 7.		Weeks 2-7	No
Secondary	Continuous abstinence rate from target quit date (TQD) from Week 2 through Week 7.		Weeks 2-7	No
Secondary	Average number of daily cigarettes smoked from Week 2 through Week 7.		Weeks 2-7	No
Secondary	Assessment of withdrawal symptoms by Minnesota Nicotine Withdrawal Scales (MNWS) from Week 2 through Week 7.		Weeks 2-7	No
Secondary	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	No
Secondary	Assessment of tobacco craving by the Brief Questionnaire of Smoking Urges (QSU-Brief) from Week 2 through Week 7.		Weeks 2-7	No
Secondary	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	No
Secondary	Adverse events, laboratory test changes throughout the study.		Weeks 1-7	Yes

External Links

•   To obtain contact information for a study center near you, click here.