Observational, Real-life, Retrospective, Data Collection,... | NCT05209997

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

NCT05209997

Sponsor

Eurofarma Laboratorios S.A.

Status

Withdrawn

Last Update Posted

Feb 28, 2025Actual

Enrollment

0Actual

Phase

Not provided

Conditions

Overweight
Obesity

Interventions

Source document data collection

Countries

Brazil

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2025

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

The study was withdrawn following a thorough evaluation of the current scientific landscape and ongoing advancements in the field. This decision was made to ensure that the research remains aligned with the highest standards of innova

Expanded Access Info

Start Date

Dec 1, 2024Estimated

Primary Completion Date

Apr 1, 2025Estimated

Completion Date

Dec 1, 2025Estimated

First Submitted Date

Jan 14, 2022

First Submission Date that Met QC Criteria

Jan 26, 2022

First Posted Date

Jan 27, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 26, 2025

Last Update Posted Date

Feb 28, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Source document data collection	Other	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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

100 Years

Standard Ages

AdultOlder Adult

Study Population

Adult patients, of both sexes, for whom combination treatment with sibutramine and topiramate, both at any dose/dosage, with prescribed treatment between the year 2011 and the beginning of the study

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Eurofarma Laboratórios S.A		São Paulo	São Paulo	06696-000	Brazil
HC-FMUSP

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D050177	Overweight
D009765	Obesity

Ancestor Terms

ID	Term
D044343	Overnutrition
D009748	Nutrition Disorders
D009750	Nutritional and Metabolic Diseases
D001835	Body Weight

Browse Leaves

Not provided

Browse Branches

Not provided