Short Bowel Syndrome Clinical Trials

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

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Participants who are 18 years of age and who have taken GATTEX in the 60 days prior to survey implementation are eligible to participate in the survey. A caregiver may participate in this survey on behalf of a participant who is eligible but unable to complete the survey. Note: Participants who have previously participated in a GATTEX Patient Knowledge Assessment Survey, are eligible.

• HCPs (adult and pediatric) in the United States who can provide a 10-digit National Provider Identifier (NPI) number and who have prescribed GATTEX at least once regardless of their completion of the voluntary GATTEX REMS training (Prescriber Education Slide Deck) are eligible for participation in the survey. Note: HCPs who have previously participated in a GATTEX Prescriber Knowledge Assessment Survey, are eligible

Locations
United States
Massachusetts
Takeda Pharmaceuticals, U.S.A., Inc.
RECRUITING
Cambridge
Contact Information
Primary
Takeda Contact
medinfoUS@takeda.com
+1-877-825-3327
Time Frame
Start Date: 2013-08-01
Estimated Completion Date: 2031-12-31
Participants
Target number of participants: 600
Treatments
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.
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.
Related Therapeutic Areas
Sponsors
Leads: Takeda

This content was sourced from clinicaltrials.gov

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