Efficacy and Safety of Rimonabant on Weight Loss and Frequency of Binge Episodes in Obese Patients
Phase 3
Completed
- Conditions
- ObesityEating Disorders
- Registration Number
- NCT00481975
- Lead Sponsor
- Sanofi
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 289
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Change in body weight from baseline to Day 180 visit
- Secondary Outcome Measures
Name Time Method Efficacy: binge eating episodes, BES score, TFEQ dimensions, waist circumference, Body Mass Index Safety: clinical examination, vital signs, adverse events, Hospital Anxiety and Depression (HAD) scale
Trial Locations
- Locations (1)
Sanofi-Aventis Administrative Office
🇨🇭Geneva, Switzerland