Back to resultsEvaluation of Orlistat as Adjuvant Treatment of Obesity in Adults
Primary Purpose
Obesity
Status
Completed
Phase
Phase 3
Locations
Brazil
Study Type
Interventional
Intervention
Orlistat 60 mg
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Obesity
Eligibility Criteria
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.
Sites / Locations
- Centro de Medicina Reprodutiva Dr Carlos Isaia Filho
- Loema
- Allergisa
- CIPMED
- Marcio Antonio Pereira Clinica de Endocrinologia
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Orlistat 60 mg
Placebo
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Safety will be evaluated by the adverse events occurrences
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01755676
Brief Title
Evaluation of Orlistat as Adjuvant Treatment of Obesity in Adults
Official Title
A Prospective Study, Parallel, Double-blind, Multicenter for Evaluation of Efficacy of Orlistat 60 mg as Adjuvant Treatment of Obesity in Adults
Study Type
Interventional
2. Study Status
Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
September 2016 (Actual)
Primary Completion Date
December 2017 (Actual)
Study Completion Date
December 21, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
EMS
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to evaluate efficacy of orlistat 60 mg as adjuvant treatment of Obesity in adults.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
638 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Orlistat 60 mg
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Orlistat 60 mg
Intervention Description
1 tablet 3 times a day
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
1 tablet 3 times a day
Primary Outcome Measure Information:
Title
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.
Time Frame
112 days
Secondary Outcome Measure Information:
Title
Safety will be evaluated by the adverse events occurrences
Time Frame
112 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Centro de Medicina Reprodutiva Dr Carlos Isaia Filho
City
Porto Alegre
State/Province
RS
Country
Brazil
Facility Name
Loema
City
Campinas
State/Province
SP
ZIP/Postal Code
13010001
Country
Brazil
Facility Name
Allergisa
City
Campinas
State/Province
São Paulo
Country
Brazil
Facility Name
CIPMED
City
Jau
State/Province
São Paulo
Country
Brazil
Facility Name
Marcio Antonio Pereira Clinica de Endocrinologia
City
São José dos Campos
State/Province
São Paulo
Country
Brazil
12. IPD Sharing Statement
Learn more about this trial
Evaluation of Orlistat as Adjuvant Treatment of Obesity in Adults
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