Observational, Real-life, Retrospective, Data Collection, Use Sibutramine/Topiramate in Overweight Comorbidities/Obesity

Obesity Clinical Trial

— TOLERASIT  

Official title:

An Observational, Multicenter, National Study With Real-life Retrospective Data Collection on the Combined Use of Sibutramine and Topiramate as Anti-obesity Treatment in Overweight Patients With Comorbidity(Ies) or Obesity.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05209997
• Other study ID #: EF179
• Status: Not yet recruiting
• Start date: December 1, 2024
• Est. completion date: December 1, 2025

Study information

• Verified date: September 2023
• Source: Eurofarma Laboratorios S.A.
• Contact: Edilene S Macedo
• Phone: 5511 5090-8422
• Email: edilene.macedo[@]eurofarma.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

An observational, multicenter, national study with retrospective real-life data collection on the combined treatment of sibutramine and topiramate (off-label use) for the treatment of overweight with comorbidity(ies) or obesity. Data from all adult patients, of both sexes, for whom combination treatment with sibutramine and topiramate, both at any dose/dosage, were prescribed between the year 2011 and the beginning of the study will be included in the study.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1500
• Est. completion date: December 1, 2025
• Est. primary completion date: April 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

Inclusion Criteria:

• Adult patients
• Both sexes
• Diagnose of overweight with comorbidity(ies) or obesity
• Treatment use of sibutramine combined with topiramate
• Treatment prescription between 2011 and the beginning of the study

Exclusion Criteria:

• Use of topiramate for other condition besides overweight with comorbidity(ies) or obesity
• Individual use of one of the medications (sibutramine or topiramate)

Related Conditions & MeSH terms

• Obesity
• Overweight

Intervention

Other:
• Source document data collection
Data from all adult patients, of both sexes, for whom combination treatment with sibutramine and topiramate, both at any dose/dosage, were prescribed between the year 2011 and the beginning of the study will be colected in the study.

Locations

Country	Name	City	State
Brazil	Eurofarma Laboratórios S.A	São Paulo
Brazil	HC-FMUSP	São Paulo	SP

Sponsors (1)

Lead Sponsor	Collaborator
Eurofarma Laboratorios S.A.

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The percentage of patients who achieved a weight loss greater than 5%	Identification of the percentage of patients who achieved a weight loss greater than 5% in relation to the initial body weight.	20 years