Obesity
Conditions
Brief summary
The purpose of this study is to evaluate efficacy of orlistat 60 mg as adjuvant treatment of Obesity in adults.
Interventions
DRUGOrlistat 60 mg
1 tablet 3 times a day
OTHERPlacebo
1 tablet 3 times a day
Sponsors
EMS
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Safety will be evaluated by the adverse events occurrences | 112 days |
Countries
Brazil
Outcome results
None listed