NCT00081458

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 84 (actual)
• Sponsor: Shire · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Detailed 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.

Conditions

• Short Bowel Syndrome

Interventions

Type	Name	Description
DRUG	Placebo	placebo injectable subcutaneously daily into thigh or abdomen
DRUG	Teduglutide 0.05 mg/kg/d	Teduglutide 0.05 mg/kg/d daily injectable subcutaneously into the thigh or abdomen
DRUG	Teduglutide 0.1 mg/kg/d	Teduglutide 0.1 /g/kg/d daily injection subcutaneously into thigh or abdomen

Timeline

• Start date: 2004-05-25
• Primary completion: 2007-07-06
• Completion: 2007-07-06
• First posted: 2004-04-14
• Last updated: 2021-06-09
• Results posted: 2013-07-15

Locations

32 sites across 9 countries: United States, Belgium, Canada, Denmark, France, Germany, Netherlands, Poland, United Kingdom