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Efficacy and Safety of Rimonabant on Weight Loss and Frequency of Binge Episodes in Obese Patients | Clinical Trials | Clareo Health

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Efficacy and Safety of Rimonabant on Weight Loss and Frequency of Binge Episodes in Obese Patients

A Randomized, Double-Bind, Placebo-Controlled, Parallel-Group, Fixed-Dose, Multicenter Study to Assess Efficacy and Safety of Rimonabant 20 mg Versus Placebo on Weight Loss and Frequency of Binge Episodes in Obese Patients With Food Craving

NCT00481975•Sanofi

View on ClinicalTrials.gov

Summary

The primary objective is to assess the effect of rimonabant compared to placebo on weight loss over a period of 6 months when prescribed with a mild hypocaloric diet in obese patients with binge eating disorder. The secondary objectives are: * to assess the effect of rimonabant on the number of binge episodes per week, to assess the effect of rimonabant on eating behavior using the Binge Eating Scale (BES) and Three Factor Eating Questionnaire (TFEQ), * to evaluate the safety and tolerability of rimonabant over a period of 6 months.

Eligibility

Age

18 - 70 years

Sex

ALL

Healthy Volunteers

No

Inclusion Criteria

•Body Mass Index (BMI) ≥30 to ≤45 kg/m²
•Diagnosis of eating disorder using The Questionnaire on Eating and Weight Patterns (QEWP-R) for diagnosing Eating Behaviors

Exclusion Criteria

•History of surgical procedures for weight loss
•Treatment with anti-obesity drugs within 3 months prior to screening visit
•Presence or history of Diagnostic and Statistical Manual of Mental Disorders (4th edition)(DSM IV) bulimia or anorexia nervosa
•The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Locations (7)

Sanofi-Aventis Administrative Office

Bridgewater, New Jersey, United States

Sanofi-Aventis Administrative Office

Helsinki, Finland

Sanofi-Aventis Administrative Office

Paris, France

Sanofi-Aventis Administrative Office

Gouda, Netherlands

Sanofi-Aventis Administrative Office

Porto Salvo, Portugal

Sanofi-Aventis Administrative Office

Bromma, Sweden

Sanofi-Aventis Administrative Office

Geneva, Switzerland

Key Dates

Start Date

August 1, 2004

Primary Completion Date

August 1, 2005

Completion Date

August 1, 2005

Last Updated

April 7, 2009

Enrollment

289

ACTUAL participants

Conditions

ObesityEating Disorders

Interventions

rimonabant (SR141716)

DRUG

Sponsors

Lead Sponsor

Sanofi

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 7, 2009Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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