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Safety and Efficacy Study of Teduglutide in Subjects With Short Bowel Syndrome
This study has been completed.
First Received: April 13, 2004   Last Updated: January 20, 2009   History of Changes
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

Resource links provided by NLM:


Further study details as provided by NPS Pharmaceuticals:

Estimated Enrollment: 125
Study Start Date: April 2004
Study Completion Date: July 2007
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Men and women, aged 18 years of age or older at the time of signing the informed consent form (ICF)
  • SBS as a result of major intestinal resection resulting in at least 12 months intravenous feeding
  • Body weight must be less than 90 kg
  • At baseline, subjects must require PN treatment to meet their caloric or electrolyte needs due to ongoing malabsorption at least 3 times weekly and to be on a stable PN regimen for 4 weeks before dosing
  • Body mass index (BMI) 18 to 27 kg/m2
  • Adequate hepatic and renal function

Exclusion Criteria:

  • History of cancer or clinically significant lymphoproliferative disease with fewer than 5 years documented disease-free state
  • History of alcohol or drug abuse (within previous year)
  • Participation in a clinical study within 30 days prior to signing the ICF, or concurrent participation in any clinical study
  • Clinically significant laboratory abnormalities at the time of randomization
  • Previous use of teduglutide (ALX-0600)
  • Prior use of native GLP-2 within 3 months of screening visit
  • Hospital admission within 1 month prior to screening visit
  • Pregnant or lactating women
  • Any condition or circumstance, which in the investigator's opinion would put the subject at any undue risk, prevent completion of the study, or interfere with analysis of the study results.
  • Presence of excluded disease: Radiation enteritis, Scleroderma, Celiac disease, Refractory/Tropical sprue, Pseudo-obstruction, Active inflammatory bowel disease (IBD), Pre-malignant/malignant change in colonoscopy biopsy or polypectomy, Surgery scheduled within the time frame of the study, Human immunodeficiency virus (HIV) positive test, Immunological disorders, Possible allergies to teduglutide or its constituents, Significant, active, uncontrolled, untreated systemic diseases
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00081458

  Hide Study Locations
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
Sponsors and Collaborators
NPS Pharmaceuticals
Investigators
Study Director: Dominique Adkins NPS
  More Information

Additional Information:
Publications:
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

Keywords provided by NPS Pharmaceuticals:
Short Bowel Syndrome
Parenteral Nutrition
SBS

Additional relevant MeSH terms:
Disease
Pathologic Processes
Digestive System Diseases
Postoperative Complications
Gastrointestinal Diseases
Syndrome
Malabsorption Syndromes
Short Bowel Syndrome
Intestinal Diseases

ClinicalTrials.gov processed this record on November 27, 2009