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

Obesity Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00481975
• Other study ID #: ACT3801
• Status: Completed
• Phase: Phase 3
• First received: June 1, 2007
• Last updated: April 6, 2009
• Start date: August 2004
• Est. completion date: August 2005

Study information

• Verified date: April 2009
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationFinland: Finnish Medicines AgencySwitzerland: Swissmedic
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 289
• Est. completion date: August 2005
• Est. primary completion date: August 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Eating Disorders
• Obesity

Intervention

Drug:
• rimonabant (SR141716)

Locations

Country	Name	City	State
Finland	Sanofi-Aventis Administrative Office	Helsinki
France	Sanofi-Aventis Administrative Office	Paris
Netherlands	Sanofi-Aventis Administrative Office	Gouda
Portugal	Sanofi-Aventis Administrative Office	Porto Salvo
Sweden	Sanofi-Aventis Administrative Office	Bromma
Switzerland	Sanofi-Aventis Administrative Office	Geneva
United States	Sanofi-Aventis Administrative Office	Bridgewater	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Countries where clinical trial is conducted

United States,  Finland,  France,  Netherlands,  Portugal,  Sweden,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in body weight from baseline to Day 180 visit
Secondary	Efficacy: binge eating episodes, BES score, TFEQ dimensions, waist circumference, Body Mass Index
Secondary	Safety: clinical examination, vital signs, adverse events, Hospital Anxiety and Depression (HAD) scale