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| Sponsor: | NPS Pharmaceuticals |
|---|---|
| Information provided by: | NPS Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT00081458 |
Purpose
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).
| Condition | Intervention | Phase |
|---|---|---|
|
Short Bowel Syndrome Parenteral Nutrition |
Drug: Teduglutide |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | A Study of the Efficacy and Safety of Teduglutide in Subjects With Parenteral Nutrition-Dependent Short Bowel Syndrome |
| Estimated Enrollment: | 125 |
| Study Start Date: | April 2004 |
| Study Completion Date: | July 2007 |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
Show 28 Study Locations| Study Director: | Dominique Adkins | NPS |
More Information
| Study ID Numbers: | CL0600-004 |
| Study First Received: | April 13, 2004 |
| Last Updated: | January 20, 2009 |
| ClinicalTrials.gov Identifier: | NCT00081458 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Short Bowel Syndrome Parenteral Nutrition SBS |
|
Disease Pathologic Processes Digestive System Diseases Postoperative Complications Gastrointestinal Diseases |
Syndrome Malabsorption Syndromes Short Bowel Syndrome Intestinal Diseases |