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Safety and Efficacy Study of Teduglutide in Subjects With Short Bowel Syndrome

Short Bowel Syndrome Clinical Trial

Official title:
A Study of the Efficacy and Safety of Teduglutide in Subjects With Parenteral Nutrition-Dependent Short Bowel Syndrome

Clinical Trial 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).

Clinical Trial Description

Teduglutide is an analog of glucagon-like peptide 2 (GLP-2), a naturally occurring hormone that regulates the growth, proliferation, and maintenance of cells lining the gastrointestinal tract. Teduglutide has been shown in animal studies and previous human clinical trials to increase the size and number of these cells, thereby increasing the absorptive surface area of the intestines. The multicenter, double-blind, international Phase III trial will randomly assign approximately 80 patients to receive daily subcutaneous injections of 0.05 milligrams or 0.10 milligrams of teduglutide per kilogram of body weight, or a placebo. Dosing will continue for a period of six months. The primary endpoint in the study is a reduction in the use of intravenous feeding, which is often required to sustain life in patients with SBS. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00081458
Study type Interventional
Source Takeda
Contact
Status Completed
Phase Phase 3
Start date May 25, 2004
Completion date July 6, 2007
View Details
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