NCT05561647

A Survey to Assess Participants' and Physicians' Knowledge When Using GATTEX (Knowledge Assessment Survey)

Quantitative Testing of Patient and Prescriber Knowledge About GATTEX (Teduglutide) for Injection Safety and Use Information

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 600 (estimated)
• Sponsor: Takeda · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The study is about learning and documenting how well participants and physicians understand how to use GATTEX and about potential risks by using a survey (called Knowledge Assessment Survey). This survey, which is conducted every two years, is part of the Gattex Risk Evaluation and Mitigation Strategy (REMS). REMS is a safety program required by the US health authority (FDA) for certain medicines that have serious risks. REMS intends to help reduce these risks while still allowing treatment. The goal is to make sure these medicines are used in the safest way possible. The main aim of this survey is to find out how well participants and physicians understand the checkups and tests (so called monitoring) participants should have while taking GATTEX, and the possible risks or of using GATTEX to treat Short Bowel Syndrome. The knowledge assessment survey will be done via internet, telephone, or paper and both physicians and participants will be able to choose the method that is preferred. No study medicines will be provided to participants in this study.

Conditions

• Short Bowel Syndrome (SBS)

Interventions

Type	Name	Description
OTHER	No Intervention	This is non-interventional study.

Timeline

• Start date: 2013-08-01
• Primary completion: 2031-12-31
• Completion: 2031-12-31
• First posted: 2022-09-30
• Last updated: 2026-01-26

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study