Evaluation of Orlistat as Adjuvant Treatment of Obesity in Adults

Phase 3

Completed

• Conditions: Obesity
• Interventions: Drug: Orlistat 60 mg; Other: Placebo

• Registration Number: NCT01755676
• Lead Sponsor: EMS

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-12-17
• Study First Submitted QC: 2012-12-19
• Study First Posted: 2012-12-24
• Study Start: 2016-09
• Primary Completion: 2017-12
• Study Completion: 2017-12-21
• Status Verified: 2020-04
• Last Update Submitted: 2020-04-06
• Last Update Posted: 2020-04-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 638

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Orlistat 60 mg	Orlistat 60 mg	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
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.	112 days

Secondary Outcome Measures

Name	Time	Method
Safety will be evaluated by the adverse events occurrences	112 days

Trial Locations

Locations (5)

Loema; 🇧🇷 Campinas, SP, Brazil

Centro de Medicina Reprodutiva Dr Carlos Isaia Filho; 🇧🇷 Porto Alegre, RS, Brazil

CIPMED; 🇧🇷 Jau, São Paulo, Brazil

Marcio Antonio Pereira Clinica de Endocrinologia; 🇧🇷 São José dos Campos, São Paulo, Brazil

Allergisa; 🇧🇷 Campinas, São Paulo, Brazil