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

This study has been completed.
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00481975
First received: June 1, 2007
Last updated: April 6, 2009
Last verified: April 2009

June 1, 2007
April 6, 2009
August 2004
August 2005   (final data collection date for primary outcome measure)
Change in body weight from baseline to Day 180 visit
Same as current
Complete list of historical versions of study NCT00481975 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
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

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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
  • Obesity
  • Eating Disorders
Drug: rimonabant (SR141716)
Not Provided
Pataky Z, Gasteyger C, Ziegler O, Rissanen A, Hanotin C, Golay A. Efficacy of rimonabant in obese patients with binge eating disorder. Exp Clin Endocrinol Diabetes. 2013 Jan;121(1):20-6. doi: 10.1055/s-0032-1329957. Epub 2012 Nov 12.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
289
August 2005
August 2005   (final data collection date for primary outcome measure)

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.

Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Finland,   France,   Netherlands,   Portugal,   Sweden,   Switzerland
 
NCT00481975
ACT3801
Not Provided
ICD Study Director, sanofi-aventis
Sanofi
Not Provided
Study Director: ICD CSD Sanofi
Sanofi
April 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP