ObesityPhase 3NCT00481975
Efficacy and Safety of Rimonabant on Weight Loss and Frequency of Binge Episodes in Obese Patients
A Phase 3 study testing rimonabant (SR141716) in people with Obesity and Eating Disorders, run by Sanofi at 7 sites in 7 countries.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Obesity, Eating Disorders
- What is being tested?
- rimonabant (SR141716)
- How many people
- 289 participants
- Where
- 7 sitesin 7 countries
- Study dates
- Aug 2004to Aug 2005
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
7 sites in 7 countries.
7 sites in 7 countries
United States1 site
Sanofi-Aventis Administrative Office
Bridgewater, New Jersey, 08807
About this study
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
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.
- Conditions
- Obesity, Eating Disorders
- Being tested
- rimonabant (SR141716)
- Keywords
- binge eating, eating disorders, obesity
- Medical subject headings
- Obesity, Feeding and Eating Disorders, Bulimia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rimonabant (SR141716)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2007 (estimated)
- Study startAug 2004
- Primary completionAug 2005
- Study completionAug 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by SanofiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 289 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- ICD CSD, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00481975
- Sponsor's protocol ID
- ACT3801
- Status last verified
- Apr 2009
- First submitted
- 1 Jun 2007
- Last updated
- 7 Apr 2009
- Results posted
- No
Publications
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.
PubMed 23147209
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00481975
- Acronym / sponsor ID
- ACT3801
- Conditions
- Obesity, Eating Disorders
- Keywords
- binge eating, eating disorders, obesity
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 289 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Aug 2004
- Primary completion
- Aug 2005 (actual)
- Study completion
- Aug 2005 (actual)
- First posted
- 4 Jun 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| rimonabant (SR141716) | Drug | – |
Primary outcome
Change in body weight from baseline to Day 180 visit
2 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2009.
- Derived from this study: PubMed 23147209Pataky 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ICD CSD study director
Sanofi
7 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing rimonabant (SR141716) in people with Obesity and Eating Disorders, run by Sanofi at 7 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Apr 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States, Finland, France, Netherlands, Portugal and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in body weight from baseline to Day 180 visit. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00481975, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2009.