Evaluation of Orlistat as Adjuvant Treatment of Obesity in Adults
A Prospective Study, Parallel, Double-blind, Multicenter for Evaluation of Efficacy of Orlistat 60 mg as Adjuvant Treatment of Obesity in Adults
1 other identifier
interventional
638
1 country
5
Brief Summary
The purpose of this study is to evaluate efficacy of orlistat 60 mg as adjuvant treatment of Obesity in adults.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 obesity
Started Sep 2016
Shorter than P25 for phase_3 obesity
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 17, 2012
CompletedFirst Posted
Study publicly available on registry
December 24, 2012
CompletedStudy Start
First participant enrolled
September 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
December 21, 2017
CompletedApril 7, 2020
April 1, 2020
1.2 years
December 17, 2012
April 6, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Safety will be evaluated by the adverse events occurrences
112 days
Study Arms (2)
Orlistat 60 mg
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Signed Informed Consent;
- Adults Male and Female ≥ 18 years old;
- Obesity (BMI ≥ 30kg/m2 or ≥ 27 Kg/m2 with associate risk);
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- EMSlead
Study Sites (5)
Centro de Medicina Reprodutiva Dr Carlos Isaia Filho
Porto Alegre, Rio Grande do Sul, Brazil
Loema
Campinas, São Paulo, 13010001, Brazil
Allergisa
Campinas, São Paulo, Brazil
CIPMED
Jaú, São Paulo, Brazil
Marcio Antonio Pereira Clinica de Endocrinologia
São José dos Campos, São Paulo, Brazil
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 17, 2012
First Posted
December 24, 2012
Study Start
September 1, 2016
Primary Completion
December 1, 2017
Study Completion
December 21, 2017
Last Updated
April 7, 2020
Record last verified: 2020-04