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

Conditions

• Short Bowel Syndrome (SBS)

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• No Intervention — OTHER
  This is non-interventional study.

Study Details

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.

Key Dates

Start date

Aug 1, 2013

Status verified

Jan 2026

Primary completion

Dec 31, 2031

Completion

Dec 31, 2031

Study Design

Enrollment

600 participants (estimated)

Arms

• Arm: GATTEX: Participants
  Participants who have taken GATTEX in the 60 days prior to survey implementation are eligible to participate in this Risk Evaluation and Mitigation Strategy (REMS) survey via internet, telephone, and paper.
• Arm: GATTEX: Healthcare Providers (Prescribers)
  HCPs (adult and pediatric) in the United States (US) who have prescribed GATTEX at least once regardless of their completion of the voluntary GATTEX REMS training are eligible for participation in this REMS survey via internet, telephone, and paper.

Primary Outcome Measure

Number of Participants and Prescribers Providing Correct Responses to Questions [ Time Frame: Up to 18 years ]

Central Contacts

• Takeda Contact
  +1-877-825-3327
  [email protected]

Locations (1)

Find similar trials in Cambridge, MA

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