|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| 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
Hide Study Locations| United States, Arizona | |
| Mayo Clinic Scottsdale | |
| Scottsdale, Arizona, United States, 85259 | |
| United States, District of Columbia | |
| Georgetown University | |
| Washington, District of Columbia, United States, 20007 | |
| United States, Georgia | |
| Emory University Hospital | |
| Atlanta, Georgia, United States, 30322 | |
| United States, Illinois | |
| Northwestern Center for Clinical Research | |
| Chicago, Illinois, United States, 60611 | |
| United States, Kansas | |
| University of Kansas Medical Center | |
| Kansas City, Kansas, United States, 66160 | |
| United States, Nebraska | |
| University of Nebraska Medical Center | |
| Omaha, Nebraska, United States, 68198 | |
| United States, New York | |
| Albany Medical Center | |
| Albany, New York, United States, 12208 | |
| University of Rochester Medical Center | |
| Rochester, New York, United States, 14642 | |
| Mount Sinai School of Medicine | |
| New York, New York, United States, 10029 | |
| United States, Ohio | |
| The Cleveland Clinic Foundation | |
| Cleveland, Ohio, United States, 44195 | |
| United States, Pennsylvania | |
| University of Pennsylvania - Penn Nursing | |
| Philadelphia, Pennsylvania, United States, 19104 | |
| University of Pittsburgh Medical Center | |
| Pittsburgh, Pennsylvania, United States, 15213 | |
| United States, Rhode Island | |
| Rhode Island Hospital | |
| Providence, Rhode Island, United States, 02903 | |
| United States, South Carolina | |
| Medical University of South Carolina | |
| Charleston, South Carolina, United States, 29425 | |
| Belgium | |
| l'Hôpital Erasme | |
| Brussels, Belgium, 1070 | |
| Canada, Alberta | |
| Royal Alexandra Hospital | |
| Edmonton, Alberta, Canada, T5H4B9 | |
| Canada, British Columbia | |
| St. Paul's Hospital | |
| Vancouver, British Columbia, Canada, V6Z1Y6 | |
| Canada, Ontario | |
| Toronto General Hospital | |
| Toronto, Ontario, Canada, M5G2N2 | |
| St. Michael's Hospital | |
| Toronto, Ontario, Canada, M5B1W8 | |
| Denmark | |
| Rigshospitalet, University of Copenhagen | |
| Copenhagen, Denmark, 2100 | |
| France | |
| Hôpital de la Croix-Rousse | |
| Lyon, France, 69317 | |
| Hôpital Beaujon | |
| Paris, France, 92110 | |
| Hôpital Claude-Huriez | |
| Lille, France, 59037 | |
| Germany | |
| Charité University Hospital | |
| Berlin, Germany, 10117 | |
| Netherlands | |
| Academic Medical Center | |
| Amsterdam, Netherlands, 1100 DD | |
| Poland | |
| Samodzielny Publiczny Szpital Kliniczny-Im.prof W.Orłowskiego CMKP | |
| Warsaw, Poland, 00-416 | |
| Pracownia Żywienia Klinicznego | |
| Olsztyn, Poland, 10-651 | |
| United Kingdom | |
| St. Mark's Hospital | |
| Harrow, United Kingdom, HA13UJ | |
| 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 |