Evaluation of Orlistat as Adjuvant Treatment of Obesity in Adults

April 6, 2020 updated by: EMS

A Prospective Study, Parallel, Double-blind, Multicenter for Evaluation of Efficacy of Orlistat 60 mg as Adjuvant Treatment of Obesity in Adults

The purpose of this study is to evaluate efficacy of orlistat 60 mg as adjuvant treatment of Obesity in adults.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

638

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • RS
      • Porto Alegre, RS, Brazil
        • Centro de Medicina Reprodutiva Dr Carlos Isaia Filho
    • SP
      • Campinas, SP, Brazil, 13010001
        • Loema
    • São Paulo
      • Campinas, São Paulo, Brazil
        • Allergisa
      • Jau, São Paulo, Brazil
        • CIPMED
      • São José dos Campos, São Paulo, Brazil
        • Marcio Antonio Pereira Clinica de Endocrinologia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Signed Informed Consent;
  • Adults Male and Female ≥ 18 years old;
  • Obesity (BMI ≥ 30kg/m2 or ≥ 27 Kg/m2 with associate risk);

Exclusion Criteria:

  • Pregnancy and Lactation or women without effective contraception;
  • Relevant clinical diseases;
  • Obesity associated to genetic syndrome;
  • Decompensated 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Other: Placebo
1 tablet 3 times a day
Experimental: Orlistat 60 mg
Drug: Orlistat 60 mg
1 tablet 3 times a day

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Efficacy of Orlistat 60 mg associated with diet and exercise in relation to placebo associated with diet and exercise in obesity treatment based on weight loss.
Time Frame: 112 days
112 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Safety will be evaluated by the adverse events occurrences
Time Frame: 112 days
112 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

EMS

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2016

Primary Completion (Actual)

December 1, 2017

Study Completion (Actual)

December 21, 2017

Study Registration Dates

First Submitted

December 17, 2012

First Submitted That Met QC Criteria

December 19, 2012

First Posted (Estimate)

December 24, 2012

Study Record Updates

Last Update Posted (Actual)

April 7, 2020

Last Update Submitted That Met QC Criteria

April 6, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ORL60EMS0511

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe