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Teduglutide for Enterocutaneous Fistula (ECF)

NCT02889393 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2021-10-06

Study results available
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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.

Conditions

  • Postoperative Fistula

Interventions

DRUG

Teduglutide

Daily 0.05 mg/kg Teduglutide administered subcutaneously.

OTHER

Standard of Care

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.

Sponsors & Collaborators

  • Takeda

    collaborator INDUSTRY

  • Daniel Dante Yeh

    lead OTHER

Principal Investigators

  • Daniel D Yeh, MD · University of Miami

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-01-31
Primary Completion
2020-07-15
Completion
2021-07-15
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02889393 on ClinicalTrials.gov