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Evaluation of Orlistat as Adjuvant Treatment of Obesity in Adults

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2017 by EMS
Sponsor:
Information provided by (Responsible Party):
EMS
ClinicalTrials.gov Identifier:
NCT01755676
First received: December 17, 2012
Last updated: January 25, 2017
Last verified: January 2017
  Purpose
The purpose of this study is to evaluate efficacy of orlistat 60 mg as adjuvant treatment of Obesity in adults.

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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Care Provider, Investigator, Outcomes Assessor
Primary Purpose: Treatment
Official Title: A Prospective Study, Parallel, Double-blind, Multicenter for Evaluation of Efficacy of Orlistat 60 mg as Adjuvant Treatment of Obesity in Adults

Resource links provided by NLM:


Further study details as provided by EMS:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • Safety will be evaluated by the adverse events occurrences [ Time Frame: 112 days ]

Estimated Enrollment: 570
Actual Study Start Date: September 2016
Estimated Study Completion Date: September 2017
Estimated Primary Completion Date: June 2017 (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 and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01755676

Contacts
Contact: Roberto B. Amazonas, MD +551938879851 pesquisa.clinica@ems.com.br

Locations
Brazil
Centro de Medicina Reprodutiva Dr Carlos Isaia Filho Recruiting
Porto Alegre, RS, Brazil
Contact: Carlos Isaia Filho, MD    55 51 3222-8180      
Principal Investigator: Carlos Isaia Filho, MD         
Loema Recruiting
Campinas, SP, Brazil, 13010001
Contact: Fabio R Santos, MD       contato@loemaipc.com.br   
Principal Investigator: Fabio R Santos, MD         
Allergisa Recruiting
Campinas, São Paulo, Brazil
Contact: Mauro A Crippa, MD         
CIPMED Recruiting
Jau, São Paulo, Brazil
Contact: Paula Tokunaga, PI         
Marcio Antonio Pereira Clinica de Endocrinologia Recruiting
São José dos Campos, São Paulo, Brazil
Contact: Marcio A. Pereira, MD         
Sponsors and Collaborators
EMS
  More Information

Responsible Party: EMS
ClinicalTrials.gov Identifier: NCT01755676     History of Changes
Other Study ID Numbers: ORL60EMS0511 
Study First Received: December 17, 2012
Last Updated: January 25, 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Orlistat
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Obesity Agents

ClinicalTrials.gov processed this record on February 24, 2017