Obesity
Conditions
Interventions
The study has two treatment arms: intestinal lipase inhibitor 60mg and 120mg.
Randomization will be performed using a random sequence, using the block diagram of 12.
300 patients will be included in
Drug
D08.811.277.352.100.400
Sponsors
Marcio Antonio Pereira Clinica Médica de Endocrinologia LTDA
Marcio Antonio Pereira Clinica Médica de Endocrinologia LTDA
Eligibility
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: Signed Informed Consent; Adults Male and Female over 18 years old; Obesity (body mass index equal or greater 25kg/m2);
Exclusion criteria
Exclusion criteria: Pregnancy and Lactation or women without effective contraception;Patients with Relevant chronic degenerative diseases;Obesity associated to genetic syndrome or other diseases;Patients with a history of hospitalization for decompensated diabetes in the last 6 months;Psychiatric disorders;Alcoholism: consumption of more than 3 doses of distillate, or any alcoholic drink daily; History of alimentary disorders, for example: bulimia; Use of anorectics, herbal and / or any drug (s) with or without approved indication for weight loss in the last 30 days; Use of drugs or laxatives for constipation in the last 30 days; Any history of Inflammatory Bowel Disease; History of acute diarrhea (viral or bacterial) in the last 30 days or chronic diarrhea; Patients using cyclosporine, amiodarone, dicumarinic; Prior bariatric surgery; History of anemia; Hemoglobinopathies and coagulopathy; History of cancer in the past five years; Use of corticosteroids, oral or injectable, in the last 30 days; People Related to investigators, family, employees of the sponsor or linked to the study center; Have participated in another study in the last two months; Patients who have no ability to observe / record the occurrence of gastrointestinal events.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients with weight loss after 16 weeks of treatment. The McNemar test and Stuart-Maxwell test will be used to compare between visits and chi-square test to compare the drugs. Weight loss equal to or greater than 5% of initial weight. | — |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of patients with gastrointestinal symptoms during the treatment of obesity in adults for 16 weeks; The analysis of variance (ANOVA) and covariance (ANCOVA) is used to test the changes to the secondary variables; Percentage of patients with gastrointestinal symptoms during treatment.;The rate of dropout treatment due to gastrointestinal adverse effectsduring the treatment of obesity in adults for 16 weeks; The analysis of variance (ANOVA) and covariance (ANCOVA) is used to test the changes to the secondary variables; Percentage of patients who discontinue treatment due to adverse gastrointestinal effects. | — |
Countries
Brazil
Contacts
Public ContactClaudia Freitas
EMS
Outcome results
None listed