CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 7 enrolled
Drug / intervention
Teduglutide +3 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/NCT03663582
NCT03663582Phase 3Completed
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A 24-Week Safety, Efficacy, Pharmacokinetic Study of Teduglutide in Japanese Subjects With Short Bowel Syndrome Who Are Dependent on Parenteral Support

Shire·interventional·Posted Sep 10, 2018·Updated Aug 4, 2020

In Brief

A Phase 3 clinical trial evaluating Teduglutide, Syringe, and 2 other interventions for Short Bowel Syndrome. Completed, enrolled 7 participants across 5 sites.

Detailed Summary

The objectives of this clinical study are to evaluate the safety, efficacy, and pharmacokinetics (PK) of teduglutide in Japanese participants with short bowel syndrome (SBS) who are dependent on parenteral nutrition/intravenous (PN/IV) over a 24-week treatment period.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsShort Bowel Syndrome
CountriesJapan
Collaborators--

Timeline

Phase 3CompletedFinished
20192020202120222023202420252026
First PostedSep 10, 2018
Enrollment StartJul 6, 2018
Primary CompletionAug 6, 2019
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 7.8 years ago

Interventions

Teduglutidedrug

Teduglutide 0.05 mg/kg SC injection will be administered once daily into 1 of the 4 quadrants of the abdomen or either thigh or arm.

Syringedevice

Teduglutide will be administered using syringe. Syringe is approved for use in Japan by Pharmaceuticals and Medical Devices Agency (PMDA).

Needledevice

Teduglutide will be administered using needle. Needle is approved for use in Japan by PMDA.

Vial Adapter for Devicedevice

Vial adapter for device is approved for use in Japan by PMDA.