Comparison of Efficacy and Safety of Rimonabant 5mg/Day or 20mg/Day Versus Placebo in Smoking Cessation - Full Text View

Sponsored by:	Sanofi-Aventis
Information provided by:	Sanofi-Aventis
ClinicalTrials.gov Identifier:	NCT00464165

Purpose

The primary objective is to assess the efficacy of 2 fixed doses of rimonabant versus placebo on abstinence from tobacco use in cigarette smokers.

The secondary objective is to evaluate the effects of rimonabant on craving and weight and on the clinical and biological safety and tolerability of rimonabant in a population of cigarette tobacco smokers during a 10-week treatment period and to observe the percentage of abstinent subjects during a 40-week follow-up post treatment.

Condition	Intervention	Phase
Smoking Cessation	Drug: rimonabant	Phase III

MedlinePlus related topics: Quitting Smoking Smoking

Drug Information available for: Rimonabant SR 141716A

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Comparison of the Efficacy and Safety of 2 Oral Doses of Rimonabant, 5mg/Day or 20mg/Day, Versus Placebo, as an Aid to Smoking Cessation; Multiple Country, Randomized, Double-Blind, 3-Arm, 10-Week Treatment, 40-Week Follow-up

Further study details as provided by Sanofi-Aventis:

Primary Outcome Measures:

Prolonged abstinence from smoking during the last 4 weeks of treatment reported by the subject and confirmed by exhaled carbon monoxide (CO) and cotinine measurements

Secondary Outcome Measures:

Efficacy: mean change of the total score of Questionnaire on Smoking Urges (QSU) brief scale, categorical change in body weight in subjects with Body Mass Index lower than 30 kg/m² at baseline who achieve prolonged abstinence
Safety data

Estimated Enrollment:	780
Study Start Date:	November 2002

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Smokers smoking at least 10 cigarettes/day as a mean within the 2 months preceding the screening visit
Motivated to quit with a score greater than or equal to 6 on the ten-point Motivation Scale

Exclusion Criteria:

Non tobacco cigarettes consumption
Chronic use of marijuana
Pregnancy, breastfeeding
Any clinically significant disease that might interfere with the efficacy or safety evaluation of the study drug
Concomitant use of drugs as an aid to smoking cessation or that might induce weight change

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00464165

Locations

Belgium
Sanofi-Aventis
Diegem, Belgium
Denmark
Sanofi-Aventis
Horsholm, Denmark
France
Sanofi-Aventis
Paris, France
Spain
Sanofi-Aventis
Barcelona, Spain
Sweden
Sanofi-Aventis
Bromma, Sweden
Switzerland
Sanofi-Aventis
Geneva, Switzerland
United Kingdom, Surrey
Sanofi-Aventis
Guildford, Surrey, United Kingdom

Sponsors and Collaborators

Sanofi-Aventis

More Information

Related Info This link exits the ClinicalTrials.gov site

Study ID Numbers:	EFC4474, SR141716
Study First Received:	April 20, 2007
Last Updated:	April 20, 2007
ClinicalTrials.gov Identifier:	NCT00464165
Health Authority:	United States: Food and Drug Administration; France: Ministry of Health; United Kingdom: Medicines and Healthcare Products Regulatory Agency; Sweden: Medical Products Agency

Keywords provided by Sanofi-Aventis:

abstinence

Study placed in the following topic categories:

Smoking

Additional relevant MeSH terms:

Habits

ClinicalTrials.gov processed this record on January 16, 2009