At a glance

ClinicalIndex Comparison Record

Phase 3Completed· 59 enrolled

Drug / intervention

Teduglutide 0.05mg/kg +2 moredrug

Likely dose

Teduglutide 0.05mg/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/NCT02682381

NCT02682381Phase 3Completed

Compare CT.gov

A 24-Week Double-blind, Safety, Efficacy, and Pharmacodynamic Study Investigating Two Doses of Teduglutide in Pediatric Subjects Through 17 Years of Age With Short Bowel Syndrome Who Are Dependent on Parenteral Support

Shire·interventional·Posted Feb 15, 2016·Updated Jun 9, 2021

In Brief

A Phase 3 clinical trial evaluating Teduglutide 0.05mg/kg, Teduglutide 0.025 mg/kg, and 1 other intervention for Short Bowel Syndrome. Completed, enrolled 59 participants across 27 sites in 7 countries.

Detailed Summary

Teduglutide is approved for treatment of adults with short bowel syndrome (SBS). The purpose of this study is to evaluate the safety and efficacy of teduglutide in children up to the age of 17 with SBS who are dependent on parenteral support. Subjects may choose whether to receive the study drug or to participate in a standard-of-care arm. All participants who complete the study may be eligible to receive the study drug in a long-term extension study.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsShort Bowel Syndrome

CountriesBelgium, Canada, Finland, Germany, Italy, United Kingdom, United States

Collaborators--

Timeline

Phase 3CompletedFinished

20162017201820192020202120222023202420252026

First PostedFeb 2016

Enrollment StartJun 2016

Primary CompletionAug 2017

TodayJul 2026

First PostedFeb 15, 2016

Enrollment StartJun 23, 2016

Primary CompletionAug 18, 2017

TodayJul 2, 2026

Enrollment to primary: 1.2 yearsPosted 10.4 years ago

Interventions

Teduglutide 0.05mg/kgdrug

0.05 mg/kg

Teduglutide 0.025 mg/kgdrug

0.025 mg/kg

Standard of Careother

Observational cohort for the 24-week treatment period and 4 week follow-up.