At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 11 enrolled
Drug / intervention
Teduglutidedrug
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.
A 4-Stage, Open-label, Multicenter Study Including Long-term Extension to Evaluate the Safety, Efficacy and Pharmacokinetics of Teduglutide in Japanese Subjects With PN-dependent Short Bowel Syndrome
In Brief
A Phase 3 clinical trial evaluating Teduglutide for Short Bowel Syndrome. Completed, enrolled 11 participants across 5 sites.
Detailed Summary
The purpose of this study is to evaluate the safety and efficacy of an investigational treatment (teduglutide) in Japanese patients with PN-dependent SBS. This study will also look at how teduglutide moves through the body (pharmacokinetics).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsShort Bowel Syndrome
CountriesJapan
Collaborators--
Timeline
Phase 3CompletedFinished
201520162017201820192020202120222023202420252026
Enrollment StartDec 2014
First PostedJan 2015
Primary CompletionNov 2018
TodayJul 2026
First PostedJan 19, 2015
Enrollment StartDec 18, 2014
Primary CompletionNov 5, 2018
TodayJul 2, 2026
Enrollment to primary: 3.9 yearsPosted 11.5 years ago
Interventions
Teduglutidedrug
0.05 mg/kg/day administered by subcutaneous injection over a 24-week period.