Evaluation of Orlistat Versus Placebo for Adult Obesity Treatment

This study is not yet open for participant recruitment.
Verified September 2013 by EMS
Sponsor:
Information provided by (Responsible Party):
EMS
ClinicalTrials.gov Identifier:
NCT01755676
First received: December 17, 2012
Last updated: September 24, 2013
Last verified: September 2013
  Purpose

The purpose of this study is to evaluate efficacy of orlistat 60 mg compared to placebo on weight loss and abdominal adiposity in obese adults treatment.


Condition Intervention Phase
Obesity
Drug: Orlistat 60 mg
Other: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Prospective Study, Parallel, Double-blind, Multicenter for Evaluation of Efficacy of Orlistat 60 mg for Adult Obesity Treatment Compared to Placebo Treatment.

Resource links provided by NLM:


Further study details as provided by EMS:

Primary Outcome Measures:
  • Efficacy of Orlistat 60 mg compared to placebo in obesity treatment based on weight loss and abdominal adiposity during 24 weeks. [ Time Frame: 196 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Adverse event incidence of orlistat 60mg when used for weight loss in adults [ Time Frame: 196 days ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 90
Study Start Date: December 2013
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Orlistat 60 mg Drug: Orlistat 60 mg
1 tablet 3 times a day
Placebo Comparator: Placebo Other: Placebo
1 tablet 3 times a day

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Signed Informed Consent;
  • Adults Male and Female ≥ 18 years old and ≤ 60 years old;
  • Obesity (BMI ≥ 30kg/m2)
  • Stable weight (less than 5% variation on the last 3 months);

Exclusion Criteria:

  • Pregnancy and Lactation or women without effective contraception;
  • Relevant clinical diseases;
  • Obesity associated to genetic syndrome;
  • Patients with diabetes;
  • Psychiatric disorders;
  • Alimentary disorders;
  • Use of: anorectics, herbal weight loss and/or constipation and laxatives, in the past 30 days;
  • Patients using cyclosporine or amiodarone;
  • Patients with bowel disease;
  • Prior bariatric surgery;
  • Anemia;
  • Hemoglobinopathies and coagulopathy;
  • History of cancer in the past five years;
  • Use of corticosteroids, oral or injectable, in the last 30 days.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01755676

Locations
Brazil
Instituto São José dos Campos em Pesquisas Médicas - ISPEM Not yet recruiting
São José dos Campos, São Paulo, Brazil, 12.243-280
Contact: Márcio A Pereira, MD    +55 12 39131789    larissa.trama@ispem.com.br   
Principal Investigator: Márcio A Pereira, MD         
Sponsors and Collaborators
EMS
  More Information

No publications provided

Responsible Party: EMS
ClinicalTrials.gov Identifier: NCT01755676     History of Changes
Other Study ID Numbers: ORL60EMS0511
Study First Received: December 17, 2012
Last Updated: September 24, 2013
Health Authority: Brazil: National Health Surveillance Agency

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Orlistat
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Obesity Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 17, 2014