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

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

March 5, 2008

Last Updated Date

April 7, 2008

Start Date ^†

May 2004

Current Primary Outcome Measures ^†

Carbon monoxide (CO)-confirmed 4-week continuous quit rate (4-week CQR) from Weeks 4 to 7. [ Time Frame: Weeks 4-7 ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^†

Same as current

Change History

Complete list of historical versions of study NCT00635401 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

CO-confirmed 7-day Point Prevalence from Week 2 through Week 7. [ Time Frame: Weeks 2-7 ] [ Designated as safety issue: No ]
Continuous abstinence rate from target quit date (TQD) from Week 2 through Week 7. [ Time Frame: Weeks 2-7 ] [ Designated as safety issue: No ]
Average number of daily cigarettes smoked from Week 2 through Week 7. [ Time Frame: Weeks 2-7 ] [ Designated as safety issue: No ]
Assessment of withdrawal symptoms by Minnesota Nicotine Withdrawal Scales (MNWS) from Week 2 through Week 7. [ Time Frame: Weeks 2-7 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
Assessment of tobacco craving by the Brief Questionnaire of Smoking Urges (QSU-Brief) from Week 2 through Week 7. [ Time Frame: Weeks 2-7 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
Adverse events, laboratory test changes throughout the study. [ Time Frame: Weeks 1-7 ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^†

Same as current

Descriptive Information

Brief Title ^†

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

Official Title ^†

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

Detailed Description

Study Phase

Phase II

Study Type ^†

Interventional

Study Design ^†

Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study

Condition ^†

Smoking

Intervention ^†

Drug: Varenicline

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Completed

Enrollment ^†

Completion Date

August 2004

Primary Completion Date

Eligibility Criteria ^†

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

Gender

Both

Ages

20 Years to 75 Years

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

Japan

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00635401

Responsible Party

Director, Clinical Trial Disclosure Group, Pfizer, Inc.

Secondary IDs ^††

Study Sponsor ^†

Pfizer

Collaborators ^††

Investigators ^†

Study Director:

Pfizer CT.gov Call Center

Pfizer

Information Provided By

Pfizer

Verification Date

April 2008

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.