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

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00635401

Purpose

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.

Condition	Intervention	Phase
Smoking	Drug: Varenicline	Phase II

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
Official Title:	A Multicenter, Open-Label Study Exploring the Efficacy and Safety of Varenicline in Japanese Smokers Motivated to Quit Smoking

Resource links provided by NLM:

MedlinePlus related topics: Smoking

Drug Information available for: Varenicline

U.S. FDA Resources

Further study details as provided by Pfizer:

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 ]

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 ]

Enrollment:	30
Study Start Date:	May 2004
Study Completion Date:	August 2004

Arms	Assigned Interventions
0.5 mg BID: Experimental	Drug: Varenicline 0.5 mg BID for 7 weeks

Eligibility

Ages Eligible for Study:	20 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00635401

Locations

Japan
Pfizer Investigational Site
OITA, Japan
Japan, FUKUOKA
Pfizer Investigational Site
CHUO-KU FUKUOKA, FUKUOKA, Japan
Japan, KANAGAWA
Pfizer Investigational Site
NISHI-KU YOKOHAMA, KANAGAWA, Japan
Japan, OITA
Pfizer Investigational Site
BEPPU, OITA, Japan
Japan, Shizuoka-ken
Pfizer Investigational Site
HAMAMATSU-SHI, Shizuoka-ken, Japan
Japan, TOKYO
Pfizer Investigational Site
MINATO-KU, TOKYO, Japan
Pfizer Investigational Site
EDOGAWA-KU, TOKYO, Japan
Japan, Tokyo
Pfizer Investigational Site
Toshima-ku, Tokyo, Japan

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

Link to ClinicalStudyResults.org Posting This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Pfizer, Inc. ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:	A3051043
Study First Received:	March 5, 2008
Last Updated:	April 7, 2008
ClinicalTrials.gov Identifier:	NCT00635401 History of Changes
Health Authority:	Japan: Ministry of Health, Labor and Welfare

Study placed in the following topic categories:

Smoking
Varenicline

Additional relevant MeSH terms:

Habits
Smoking

ClinicalTrials.gov processed this record on September 10, 2009