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Evaluation of Orlistat as Adjuvant Treatment of Obesity in Adults

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ClinicalTrials.gov Identifier: NCT01755676
Recruitment Status : Active, not recruiting
First Posted : December 24, 2012
Last Update Posted : January 5, 2018
Sponsor:
Information provided by (Responsible Party):
EMS

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

Condition or disease Intervention/treatment Phase
Obesity Drug: Orlistat 60 mg Other: Placebo Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 638 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
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
Actual Study Start Date : September 2016
Actual Primary Completion Date : December 2017
Estimated Study Completion Date : April 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Orlistat
U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. 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 :
  1. Safety will be evaluated by the adverse events occurrences [ Time Frame: 112 days ]


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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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01755676


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

Responsible Party: EMS
ClinicalTrials.gov Identifier: NCT01755676     History of Changes
Other Study ID Numbers: ORL60EMS0511
First Posted: December 24, 2012    Key Record Dates
Last Update Posted: January 5, 2018
Last Verified: January 2018

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