Back to resultsEfficacy and Safety of Rimonabant on Weight Loss and Frequency of Binge Episodes in Obese Patients
Primary Purpose
Obesity, Eating Disorders
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
rimonabant (SR141716)
Sponsored by
About this trial
This is an interventional treatment trial for Obesity focused on measuring binge eating, eating disorders, obesity
Eligibility 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.
Sites / Locations
- Sanofi-Aventis Administrative Office
- Sanofi-Aventis Administrative Office
- Sanofi-Aventis Administrative Office
- Sanofi-Aventis Administrative Office
- Sanofi-Aventis Administrative Office
- Sanofi-Aventis Administrative Office
- Sanofi-Aventis Administrative Office
Outcomes
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00481975
Brief Title
Efficacy and Safety of Rimonabant on Weight Loss and Frequency of Binge Episodes in Obese Patients
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 Type
Interventional
2. Study Status
Record Verification Date
April 2009
Overall Recruitment Status
Completed
Study Start Date
August 2004 (undefined)
Primary Completion Date
August 2005 (Actual)
Study Completion Date
August 2005 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Sanofi
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Eating Disorders
Keywords
binge eating, eating disorders, obesity
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
289 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
rimonabant (SR141716)
Primary Outcome Measure Information:
Title
Change in body weight from baseline to Day 180 visit
Secondary Outcome Measure Information:
Title
Efficacy: binge eating episodes, BES score, TFEQ dimensions, waist circumference, Body Mass Index
Title
Safety: clinical examination, vital signs, adverse events, Hospital Anxiety and Depression (HAD) scale
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ICD CSD
Organizational Affiliation
Sanofi
Official's Role
Study Director
Facility Information:
Facility Name
Sanofi-Aventis Administrative Office
City
Bridgewater
State/Province
New Jersey
ZIP/Postal Code
08807
Country
United States
Facility Name
Sanofi-Aventis Administrative Office
City
Helsinki
Country
Finland
Facility Name
Sanofi-Aventis Administrative Office
City
Paris
Country
France
Facility Name
Sanofi-Aventis Administrative Office
City
Gouda
Country
Netherlands
Facility Name
Sanofi-Aventis Administrative Office
City
Porto Salvo
Country
Portugal
Facility Name
Sanofi-Aventis Administrative Office
City
Bromma
Country
Sweden
Facility Name
Sanofi-Aventis Administrative Office
City
Geneva
Country
Switzerland
12. IPD Sharing Statement
Citations:
PubMed Identifier
23147209
Citation
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.
Results Reference
derived
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Efficacy and Safety of Rimonabant on Weight Loss and Frequency of Binge Episodes in Obese Patients
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