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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00481975
Recruitment Status : Completed
First Posted : June 4, 2007
Last Update Posted : April 7, 2009
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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.

Condition or disease Intervention/treatment Phase
Obesity Eating Disorders Drug: rimonabant (SR141716) Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 289 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Study Start Date : August 2004
Actual Primary Completion Date : August 2005
Actual Study Completion Date : August 2005

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Change in body weight from baseline to Day 180 visit

Secondary Outcome Measures :
  1. Efficacy: binge eating episodes, BES score, TFEQ dimensions, waist circumference, Body Mass Index
  2. Safety: clinical examination, vital signs, adverse events, Hospital Anxiety and Depression (HAD) scale

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00481975

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United States, New Jersey
Sanofi-Aventis Administrative Office
Bridgewater, New Jersey, United States, 08807
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
Sponsors and Collaborators
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Study Director: ICD CSD Sanofi
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: ICD Study Director, sanofi-aventis Identifier: NCT00481975    
Other Study ID Numbers: ACT3801
First Posted: June 4, 2007    Key Record Dates
Last Update Posted: April 7, 2009
Last Verified: April 2009
Keywords provided by Sanofi:
binge eating
eating disorders
Additional relevant MeSH terms:
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Weight Loss
Feeding and Eating Disorders
Body Weight
Body Weight Changes
Mental Disorders
Anti-Obesity Agents
Cannabinoid Receptor Antagonists
Cannabinoid Receptor Modulators
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs