Evaluation of Orlistat as Adjuvant Treatment of Obesity in Adults

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01755676
• Other study ID #: ORL60EMS0511
• Status: Completed
• Phase: Phase 3
• Start date: September 2016
• Est. completion date: December 21, 2017

Study information

• Verified date: April 2020
• Source: EMS
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 638
• Est. completion date: December 21, 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Obesity

Intervention

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

Other:
• Placebo
1 tablet 3 times a day

Locations

Country	Name	City	State
Brazil	Allergisa	Campinas	São Paulo
Brazil	Loema	Campinas	SP
Brazil	CIPMED	Jau	São Paulo
Brazil	Centro de Medicina Reprodutiva Dr Carlos Isaia Filho	Porto Alegre	RS
Brazil	Marcio Antonio Pereira Clinica de Endocrinologia	São José dos Campos	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
EMS

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Safety will be evaluated by the adverse events occurrences		112 days