CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 86 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/NCT00798967
NCT00798967Phase 3Completed
CompareCT.gov

A 24-Week Study of the Efficacy and Safety of Teduglutide in Subjects With Parenteral Nutrition-Dependent Short Bowel Syndrome

Shire·interventional·Posted Nov 27, 2008·Updated Jun 3, 2021

In Brief

A Phase 3 clinical trial evaluating teduglutide and placebo for Short Bowel Syndrome. Completed, enrolled 86 participants across 35 sites in 10 countries.

Detailed Summary

Teduglutide is an investigative medicine being evaluated as a possible treatment for people with parenteral nutrition (PN) dependent Short Bowel Syndrome (SBS). Teduglutide is similar to a protein the body makes. When people have SBS, their bodies do not make enough of the protein and they have trouble getting nutrients and fluids from the food they eat and drink. This study was designed to provide evidence of efficacy, safety, and tolerability of teduglutide 0.05 mg/kg daily in SBS subjects.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsShort Bowel Syndrome
CountriesCanada, Denmark, France, Germany, Italy, Netherlands, Poland, Spain, United Kingdom, United States
CollaboratorsNycomed

Timeline

Phase 3CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedNov 27, 2008
Enrollment StartNov 25, 2008
Primary CompletionJan 25, 2011
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 17.6 years ago

Interventions

teduglutidedrug

0.05 mg/kg/day sc injection for 24 weeks

placebodrug

Matching daily subcutaneous dose of placebo to teduglutide for 24 weeks