Efficacy and Safety of Rimonabant as an Aid to Maintenance of Smoking Cessation

Maintenance of Smoking Cessation Clinical Trial

— STRATUS-WW  

Official title:

Comparison of the Efficacy and Safety of 2 Oral Doses of Rimonabant, 5 mg/Day or 20 mg/Day, Versus Placebo, as an Aid to Maintenance of Smoking Cessation (1-Year Treatment, 1-Year Follow-up)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00459173
• Other study ID #: EFC4796
• Status: Completed
• Phase: Phase 3
• First received: April 10, 2007
• Last updated: April 6, 2009
• Start date: November 2002
• Est. completion date: September 2005

Study information

• Verified date: April 2009
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationCanada: Health CanadaAustralia: Department of Health and Ageing Therapeutic Goods Administration
• Study type: Interventional

Clinical Trial Summary

The primary study objective is to evaluate the efficacy of 2 dose levels of rimonabant (5 mg and 20 mg) for the maintenance of abstinence from smoking.

Secondary objectives are to evaluate the effect of rimonabant on craving and weight, the clinical and biological safety of 2 doses of rimonabant rimonabant during a 12-month treatment period and to evaluate the pharmacokinetics of the drug.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4850
• Est. completion date: September 2005
• Est. primary completion date: September 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Maintenance of Smoking Cessation

Intervention

Drug:
• rimonabant (SR141716)

Locations

Country	Name	City	State
Australia	Sanofi-Aventis	Cove	New South Wales
Canada	Sanofi-Aventis	Laval	Quebec
United States	Sanofi-Aventis	Bridgewater	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Countries where clinical trial is conducted

United States,  Australia,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to smoking relapse from the point of re-randomization (Week 10) through Week 32
Primary	Smoking relapse defined as: any 7 or more consecutive days of smoking (even a puff) or any 2 consecutive days of smoking 5 or more cigarettes per day
Secondary	Efficacy: Time to smoking relapse from Week 10 to Week 52, craving, body weight change in abstainers, lipid parameters
Secondary	Safety data