CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 6 enrolled
Drug / intervention
Teduglutide +1 moredrug
Likely dose
Teduglutide 0.05 mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02889393
NCT02889393Phase 2Completed
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Teduglutide for Treatment of Enterocutaneous Fistula (ECF) - a Pilot Study to Demonstrate Safety and Feasibility

Daniel Dante Yeh·interventional·Posted Sep 5, 2016·Updated Oct 6, 2021

In Brief

A Phase 2 clinical trial evaluating Teduglutide and Standard of Care for Postoperative Fistula. Completed, enrolled 6 participants across 1 site.

Detailed Summary

The purpose of this study is to determine whether Teduglutide is safe and feasible to be given for the treatment of enterocutaneous fistula (ECF). The hypothesis is that the drug will be well tolerated and will improve the volume of daily ECF output as well as improve the functional quality of life.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPostoperative Fistula
CountriesUnited States
CollaboratorsTakeda

Timeline

Phase 2CompletedFinished
2017201820192020202120222023202420252026
First PostedSep 5, 2016
Enrollment StartJan 31, 2019
Primary CompletionJul 15, 2020
Study CompletionJul 15, 2021
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 9.8 years ago

Interventions

Teduglutidedrug

Daily 0.05 mg/kg Teduglutide administered subcutaneously.

Standard of Careother

The standard of care treatment of ECF which includes meticulous wound care, optimizations of nutrition, use of acid-suppression medications and anti-motility agents as per treating physician discretion.