Observational, Real-life, Retrospective, Data Collection, Use Sibutramine/topiramate in Overweight Comorbidities/obesity

Withdrawn

• Conditions: Obesity; Overweight

• Registration Number: NCT05209997
• Lead Sponsor: Eurofarma Laboratorios S.A.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-01-14
• Study First Submitted QC: 2022-01-26
• Study First Posted: 2022-01-27
• Study Start: 2024-12-01
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-26
• Last Update Posted: 2025-02-28
• Primary Completion: 2025-04-01
• Study Completion: 2025-12-01

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: 1500

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The percentage of patients who achieved a weight loss greater than 5%	20 years	Identification of the percentage of patients who achieved a weight loss greater than 5% in relation to the initial body weight.

Trial Locations

Locations (2)

HC-FMUSP; 🇧🇷 São Paulo, SP, Brazil

Eurofarma Laboratórios S.A; 🇧🇷 São Paulo, Brazil