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

• Sponsor: Eurofarma Laboratorios S.A. (Industry)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05209997
• Collaborator: (none)
• Enrollment: 1,500
• Location: 1
• Anticipated Duration (Months): 16
• Patients Per Site Per Month: 93.9

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Overweight; Obesity	Other: Source document data collection

Study Design

• Study Type: Observational
• Anticipated Enrollment: 1500 participants
• Observational Model: Other
• Time Perspective: Retrospective
• 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.
• Anticipated Study Start Date: Jan 1, 2023
• Anticipated Primary Completion Date: May 1, 2024
• Anticipated Study Completion Date: May 1, 2024

Outcome Measures

Primary Outcome Measures

1. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 100 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	HC-FMUSP	São Paulo	SP	Brazil

Sponsors and Collaborators

• Eurofarma Laboratorios S.A.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Eurofarma Laboratorios S.A.
• ClinicalTrials.gov Identifier: NCT05209997
• Other Study ID Numbers: EF179
• First Posted: Jan 27, 2022
• Last Update Posted: Jul 29, 2022
• Last Verified: Jul 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Obesity; Overweight

Study Results

No Results Posted as of Jul 29, 2022