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Completed

NCT Number: NCT01755676

Evaluation of Orlistat 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.

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Key information

Conditions

Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Centro de Medicina Reprodutiva Dr Carlos Isaia Filho, Porto Alegre, Rio Grande do Sul, Brazil

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

orlistat 60 mg

Drug

1 tablet 3 times a day

Placebo

Other

1 tablet 3 times a day

Primary outcomes

  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 outcomes

  1. Safety will be evaluated by the adverse events occurrences

    Time frame: 112 days

Sponsors and collaborators

Lead sponsor

EMS

Industry

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Dec 24, 2012
Registry last updated
Apr 7, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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