NCT00464165|CompletedPhase 3

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

STRATUS-EU

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

Sanofi ClinicalTrials.gov

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2 other identifiers

EFC4474SR141716

Study Type

interventional

Target

789

Locations

7 countries

Sites

Timeline

RegisteredApr 2007

StartedNov 2002

CompletionOct 2003

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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

789

participants targeted

Target at P75+ for phase_3

Timeline

Completed

Started Nov 2002

Shorter than P25 for phase_3

Geographic Reach

7 countries

7 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

11 months study duration

Study Start

First participant enrolled

November 1, 2002

Completed

11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2003

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2003

Completed

3.6 years until next milestone

First Submitted

Initial submission to the registry

April 20, 2007

Completed

3 days until next milestone

First Posted

Study publicly available on registry

April 23, 2007

Completed

Last Updated

December 10, 2010

Status Verified

December 1, 2010

Enrollment Period

11 months

First QC Date

April 20, 2007

Last Update Submit

December 9, 2010

Conditions

Smoking Cessation

Keywords

abstinence

Outcome Measures

Primary Outcomes (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 Outcomes (2)

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

Interventions

rimonabantDRUG

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.