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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

  Show 28 Study Locations
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 25, 2009