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NCT05561647·Not applicable·OBSERVATIONAL

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

TeduglutideOtherRecruiting

Status

Recruiting

Phase

Not applicable

Enrollment

600

Locations

1

Results

Not posted

Publications

0

Study summary

What the protocol is testing.

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.

Interventions

Treatment arms and agents.

OTHER

No Intervention

This is non-interventional study.

Timeline

From registration to results.

  1. First posted

    Sep 30, 2022

  2. Study start

    Aug 1, 2013

  3. Primary completion

    Dec 31, 2031

  4. Study completion

    Dec 31, 2031

  5. Results posted

    Not reported

  6. Registry updated

    Jan 26, 2026

Outcomes

What the study measures.

Primary outcomes

Number of Participants and Prescribers Providing Correct Responses to Questions

Time frame · Up to 18 years

All questions for survey knowledge domain and about GATTEX will be asked through a questionnaire, Participant or HCPs would need to respond true or false to each question based upon understanding and knowledge. Respondents could be participants or HCPs.

Secondary outcomes

Number of Participants and Prescribers Providing At Least 80 Percent (%) Correct Responses to Each Survey Knowledge Domains

Time frame · Up to 18 years

The questions will be asked to participants and HCPs and will be counted as correct if 80% of the correct responses are provided and not more than 1 incorrect response is provided. In each survey knowledge domain, general questions about GATTEX will be asked; participants or HCPs would need to respond true or false to each question based upon understanding and knowledge. Respondents could be participants or HCPs.

Number of Participants and Prescribers who Demonstrated Understanding of Survey Knowledge Domains

Time frame · Up to 18years

Understanding demonstration is defined as respondents who answered 80% or more questions/items in a survey knowledge domain correctly. In each survey knowledge domain, general questions about GATTEX will be asked, and participants or HCPs would need to respond true or false to each question based upon understanding and knowledge. Respondents could be participants or HCPs.

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
Not reported
Sex
ALL
Healthy volunteers
No

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 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 who are currently working for Takeda Pharmaceuticals U.S.A., Inc., NPS Pharmaceuticals, Inc., Shire, UBC, or the Food and Drug Administration (FDA) are not eligible to participate in the survey. * Respondents who reported having a conflict of interest. * HCPs who have opted out of receiving communications about the GATTEX Prescriber Knowledge 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 locations

1 registered sites.

United States. Showing up to 24 locations stored in the fast local snapshot.

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

Cambridge, Massachusetts, United States

Publications

Results and literature.

No PMID-linked publications were present in this registry snapshot.

Primary links

Continue at the source.

ClinicalTrials.gov ↗Search PubMed ↗Search FDA ↗Search EMA ↗

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