Efficacy and Safety of Rimonabant on Weight Loss and Frequency of Binge Episodes in Obese Patients
This study has been completed.
Sponsor:
Sanofi
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00481975
First received: June 1, 2007
Last updated: April 6, 2009
Last verified: April 2009
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Obesity Eating Disorders |
Drug: rimonabant (SR141716) |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by Sanofi:
Primary Outcome Measures:
- Change in body weight from baseline to Day 180 visit
Secondary Outcome 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
| Enrollment: | 289 |
| Study Start Date: | August 2004 |
| Study Completion Date: | August 2005 |
| Primary Completion Date: | August 2005 (Final data collection date for primary outcome measure) |
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00481975
Locations
| United States, New Jersey | |
| Sanofi-Aventis Administrative Office | |
| Bridgewater, New Jersey, United States, 08807 | |
| Finland | |
| Sanofi-Aventis Administrative Office | |
| Helsinki, Finland | |
| France | |
| Sanofi-Aventis Administrative Office | |
| Paris, France | |
| Netherlands | |
| Sanofi-Aventis Administrative Office | |
| Gouda, Netherlands | |
| Portugal | |
| Sanofi-Aventis Administrative Office | |
| Porto Salvo, Portugal | |
| Sweden | |
| Sanofi-Aventis Administrative Office | |
| Bromma, Sweden | |
| Switzerland | |
| Sanofi-Aventis Administrative Office | |
| Geneva, Switzerland | |
Sponsors and Collaborators
Sanofi
Investigators
| Study Director: | ICD CSD | Sanofi |
More Information
No publications provided by Sanofi
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | ICD Study Director, sanofi-aventis |
| ClinicalTrials.gov Identifier: | NCT00481975 History of Changes |
| Other Study ID Numbers: | ACT3801 |
| Study First Received: | June 1, 2007 |
| Last Updated: | April 6, 2009 |
| Health Authority: | United States: Food and Drug Administration Finland: Finnish Medicines Agency Switzerland: Swissmedic |
Keywords provided by Sanofi:
|
binge eating eating disorders obesity |
Additional relevant MeSH terms:
|
Eating Disorders Obesity Weight Loss Mental Disorders Overnutrition |
Nutrition Disorders Overweight Body Weight Signs and Symptoms Body Weight Changes |
ClinicalTrials.gov processed this record on May 23, 2013