NCT00481975|CompletedPhase 3

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

Sanofi ClinicalTrials.gov

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1 other identifier

ACT3801

Study Type

interventional

Target

289

Locations

7 countries

Sites

Timeline

RegisteredJun 2007

StartedAug 2004

CompletionAug 2005

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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

289

participants targeted

Target at P50-P75 for phase_3 obesity

Timeline

Completed

Started Aug 2004

Shorter than P25 for phase_3 obesity

Geographic Reach

7 countries

7 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

1 year study duration

Study Start

First participant enrolled

August 1, 2004

Completed

1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2005

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2005

Completed

1.8 years until next milestone

First Submitted

Initial submission to the registry

June 1, 2007

Completed

3 days until next milestone

First Posted

Study publicly available on registry

June 4, 2007

Completed

Last Updated

April 7, 2009

Status Verified

April 1, 2009

Enrollment Period

1 year

First QC Date

June 1, 2007

Last Update Submit

April 6, 2009

Conditions

Obesity Eating Disorders

Keywords

binge eatingeating disordersobesity

Outcome Measures

Primary Outcomes (1)

Change in body weight from baseline to Day 180 visit

Secondary Outcomes (2)

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

Interventions

rimonabant (SR141716)DRUG

Eligibility Criteria

Age18 Years - 70 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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.

Contact the study team to confirm eligibility.