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

StatusCompleted
PhaseNot specified
SponsorTakeda
Started

Free. We email you which fields changed when ClinicalTrials.gov updates this record.

Track this trial
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Trial completed Show 4 more changesShow less
    • Primary completion date changed from estimate of Dec 31, 2031 to Aug 26, 2026
    • Secondary endpoints: details revised at 2 of 2 entries
    • Site details revised
    • Eligibility criteria expanded, about 4 words
  2. Primary and study completion dates: Dec 31, 2026 to Dec 31, 2031v7 Show 4 more changesShow less
    • Secondary endpoints: details revised at 2 of 2 entries
    • Study site revised
    • Study title revised
    • Eligibility criteria shortened, about 1 word
  3. Re-verified, no change to tracked fieldsv6
  4. Primary and study completion dates: Dec 31, 2024 to Dec 31, 2026v5
  5. Lead sponsor: Shire to Takeda
    • Eligibility criteria expanded, about 17 words
    • Secondary endpoints revised (2)
    v4
Show 2 earlier versionsHide 2 earlier versions
  1. Primary and study completion dates: Dec 31, 2023 to Dec 31, 2024v3
  2. Study Identification, Study Status, Referencesv2
  1. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Takeda
222 trials monitored
See 14 trials at risk
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.
Trial Details
NCT Number NCT05561647
Lead Sponsor Takeda
Conditions
(from sponsor)		 Short Bowel Syndrome (SBS)
Related terms Short Bowel Syndrome
Enrollment 600 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov