CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 84 enrolled
Drug / intervention
Placebo +2 moredrug
Likely dose
Teduglutide 0.05 mg/kg/day or 0.1 mg/kg/day subcutaneously dailyAI-extracted
Key inclusion· 7
  • ✓Age ≥18 years
  • ✓Short bowel syndrome from major intestinal resection with ≥12 months of intravenous feeding
  • ✓Require parenteral nutrition ≥3 times weekly to meet caloric or electrolyte needs due to malabsorption
  • ✓Stable PN regimen for ≥4 weeks before dosing
Key exclusion· 9
  • ✕History of cancer or lymphoproliferative disease without ≥5 years documented disease-free state
  • ✕Alcohol or drug abuse within previous year
  • ✕Participation in another clinical trial within 30 days or concurrent enrollment
  • ✕Clinically significant laboratory abnormalities at randomization

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00081458
NCT00081458Phase 3Completed
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A Study of the Efficacy and Safety of Teduglutide in Subjects With Parenteral Nutrition-Dependent Short Bowel Syndrome

Shire·interventional·Posted Apr 14, 2004·Updated Jun 9, 2021

In Brief

A Phase 3 clinical trial evaluating Placebo, Teduglutide 0.05 mg/kg/d, and 1 other intervention for Short Bowel Syndrome. Completed, enrolled 84 participants across 32 sites in 9 countries.

Detailed Summary

The purpose of this study is to evaluate the efficacy, safety, tolerability, and pharmacokinetics (PK) of teduglutide compared with placebo in subjects with parenteral nutrition (PN)-dependent short bowel syndrome (SBS).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsShort Bowel Syndrome
CountriesBelgium, Canada, Denmark, France, Germany, Netherlands, Poland, United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedApr 14, 2004
Enrollment StartMay 25, 2004
Primary CompletionJul 6, 2007
TodayJul 2, 2026
Enrollment to primary: 3.1 yearsPosted 22.2 years ago

Interventions

Placebodrug

placebo injectable subcutaneously daily into thigh or abdomen

Teduglutide 0.05 mg/kg/ddrug

Teduglutide 0.05 mg/kg/d daily injectable subcutaneously into the thigh or abdomen

Teduglutide 0.1 mg/kg/ddrug

Teduglutide 0.1 /g/kg/d daily injection subcutaneously into thigh or abdomen