Clinical trial NCT00635401: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Smoking
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2008-03-13
Enrollment: 30
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Carbon monoxide (CO)-confirmed 4-week continuous quit rate (4-week CQR) from Weeks 4 to 7.
timeFrame: Weeks 4-7
Secondary outcomes:
measure: CO-confirmed 7-day Point Prevalence from Week 2 through Week 7.
timeFrame: Weeks 2-7
measure: Continuous abstinence rate from target quit date (TQD) from Week 2 through Week 7.
timeFrame: Weeks 2-7
measure: Average number of daily cigarettes smoked from Week 2 through Week 7.
timeFrame: Weeks 2-7
measure: Assessment of withdrawal symptoms by Minnesota Nicotine Withdrawal Scales (MNWS) from Week 2 through Week 7.
timeFrame: Weeks 2-7
measure: 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.
timeFrame: Weeks 2-7
measure: Assessment of tobacco craving by the Brief Questionnaire of Smoking Urges (QSU-Brief) from Week 2 through Week 7.
timeFrame: Weeks 2-7
measure: 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.
timeFrame: Weeks 2-7
measure: Adverse events, laboratory test changes throughout the study.
timeFrame: Weeks 1-7
Other outcomes:
Locations:
city: Chuo-ku Fukuoka
country: Japan
facility: Pfizer Investigational Site
state: Fukuoka
city: Nishi-ku Yokohama
country: Japan
facility: Pfizer Investigational Site
state: Kanagawa
city: Beppu
country: Japan
facility: Pfizer Investigational Site
state: Oita
city: Hamamatsu-shi
country: Japan
facility: Pfizer Investigational Site
state: Shizuoka-ken
city: Edogawa-ku
country: Japan
facility: Pfizer Investigational Site
state: Tokyo
city: Minato-ku
country: Japan
facility: Pfizer Investigational Site
state: Tokyo
city: Toshima-ku
country: Japan
facility: Pfizer Investigational Site
state: Tokyo
city: Oita
country: Japan
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: