STRATUS-EU: Comparison of Efficacy and Safety of Rimonabant 5mg/Day or 20mg/Day Versus Placebo in Smoking Cessation

• Sponsor: Sanofi (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00464165
• Collaborator: (none)
• Enrollment: 789
• Locations: 7
• Duration (Months): 11
• Patients Per Site: 112.7
• Patients Per Site Per Month: 10.3

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Smoking Cessation	Drug: rimonabant	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 789 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• 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
• Study Start Date: Nov 1, 2002
• Actual Primary Completion Date: Oct 1, 2003
• Actual Study Completion Date: Oct 1, 2003

Outcome Measures

Primary Outcome Measures

1. 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

1. 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 []

2. Safety data []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Sanofi-Aventis Administrative Office	Diegem		Belgium
2	Sanofi-Aventis Administrative Office	Horsholm		Denmark
3	Sanofi-Aventis Administrative Office	Paris		France
4	Sanofi-Aventis Administrative Office	Barcelona		Spain
5	Sanofi-Aventis Administrative Office	Bromma		Sweden
6	Sanofi-Aventis Administrative Office	Geneva		Switzerland
7	Sanofi-Aventis Administrative Office	Guildford	Surrey	United Kingdom

Sponsors and Collaborators

• Sanofi

Investigators

• Study Director: Clinical Sciences & Operations, Sanofi

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00464165
• Other Study ID Numbers: EFC4474; SR141716
• First Posted: Apr 23, 2007
• Last Update Posted: Dec 10, 2010
• Last Verified: Dec 1, 2010

• Keywords provided by , ,: abstinence
• Additional relevant MeSH terms: Rimonabant

Study Results

No Results Posted as of Dec 10, 2010