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

Last updated: January 23, 2026
Sponsor: Takeda
Overall Status: Active - Recruiting

Phase

N/A

Condition

Bowel Dysfunction

Treatment

No Intervention

Clinical Study ID

NCT05561647
TAK-633-4008
EUPAS48716
  • Ages > 18
  • All Genders

Study 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 Criteria

Inclusion

Participant inclusion criteria:

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.

Prescriber inclusion criteria:

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

Exclusion

Participant and Prescriber exclusion criteria:

  • Respondents who do not agree to participate in the survey.

  • Respondents who are currently working for and/or whose immediate family members whoare currently working for Takeda Pharmaceuticals U.S.A., Inc., NPS Pharmaceuticals,Inc., Shire, UBC, or the Food and Drug Administration (FDA) are not eligible toparticipate in the survey.

  • Respondents who reported having a conflict of interest.

  • HCPs who have opted out of receiving communications about the GATTEX PrescriberKnowledge Assessment Survey for the current wave

Further details associated with respondents who do not meet the exclusion criteria established above, will be provided in the assessment report.

Study Design

Total Participants: 600
Treatment Group(s): 1
Primary Treatment: No Intervention
Phase:
Study Start date:
August 01, 2013
Estimated Completion Date:
December 31, 2031

Connect with a study center

  • Shire-NPS Pharmaceuticals, INC.

    Lexington, Massachusetts 02421
    United States

    Site Not Available

  • Takeda Pharmaceuticals, U.S.A., Inc.

    Cambridge 4931972, Massachusetts 6254926 02142
    United States

    Active - Recruiting

  • Shire-NPS Pharmaceuticals, INC.

    Lexington 4941935, Massachusetts 6254926 02421
    United States

    Site Not Available

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