Evaluation of Orlistat as Adjuvant Treatment of Obesity in Adults

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

638 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-09-30

Study Completion Date

2017-12-21

Brief Summary

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

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Detailed Description

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Conditions

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Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Orlistat 60 mg

Group Type EXPERIMENTAL

Orlistat 60 mg

Intervention Type DRUG

1 tablet 3 times a day

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

1 tablet 3 times a day

Interventions

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Orlistat 60 mg

1 tablet 3 times a day

Intervention Type DRUG

Placebo

1 tablet 3 times a day

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No