Efficacy and Safety of Rimonabant on Weight Loss and Frequency of Binge Episodes in Obese Patients
Completed · Phase 3
Conditions studied: Obesity, Eating Disorders
In brief
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.
Key facts
- Study ID
- NCT00481975
- Run by
- Sanofi
- People needed
- 289
- Starts
- 2004-08-01
- Expected to finish
- 2005-08-01
- Last updated by the study team
- 2009-04-07
Who can join
Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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.
Where it is running
- 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
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.