Evaluation of Orlistat as Adjuvant Treatment of Obesity in Adults

Overview

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

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: December 2017

Interventions

  • Drug: Orlistat 60 mg
    • 1 tablet 3 times a day
  • Other: Placebo
    • 1 tablet 3 times a day

Arms, Groups and Cohorts

  • Experimental: Orlistat 60 mg
  • Placebo Comparator: Placebo

Clinical Trial Outcome Measures

Primary 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 Measures

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

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • EMS
  • Provider of Information About this Clinical Study
    • Sponsor

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