Efficacy and Safety of Rimonabant on Weight Loss and Frequency of Binge Episodes in Obese Patients
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...
Brief Summary
Official Title: “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”
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.
- Study Type: Interventional
- Study Design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
- Study Primary Completion Date: August 2005
Intervention(s) in this Clinical Trial
- Drug: rimonabant (SR141716)
Outcome Measures for this Clinical Trial
Primary Measures
- Change in body weight from baseline to Day 180 visit
Secondary Measures
- 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
Criteria for Participation in this Clinical Trial
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.
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 18 Years
Maximum Age for this Clinical Trial: 70 Years
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Investigator Information
Lead Investigator: Sanofi-Aventis Industry
Overall Clinical Trial Officials and Contacts
ICD CSD Study Director Sanofi-Aventis
Additional Information
Information obtained from ClinicalTrials.gov on February 12, 2012
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00481975
Study ID Number: ACT3801
ClinicalTrials.gov Identifier: NCT00481975
Health Authority: United States: Food and Drug Administration
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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00481975
