Completed

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

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What is being tested

Placebo

+ Teduglutide 0.05 mg/kg/d

+ Teduglutide 0.1 mg/kg/d

Drug
Who is being recruted

Digestive System Diseases+8

+ Gastrointestinal Diseases

+ Hyperphagia

Over 18 Years
+16 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Placebo-ControlledPhase 3
Interventional
Study Start: May 2004
See protocol details

Summary

Principal SponsorShire
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: May 25, 2004

Actual date on which the first participant was enrolled.

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.

Official TitleA Study of the Efficacy and Safety of Teduglutide in Subjects With Parenteral Nutrition-Dependent Short Bowel Syndrome
NCT00081458
Principal SponsorShire
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

84 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Digestive System DiseasesGastrointestinal DiseasesHyperphagiaIntestinal DiseasesMalabsorption SyndromesPathologic ProcessesPostoperative ComplicationsShort Bowel SyndromeSigns and SymptomsSigns and Symptoms, DigestivePathological Conditions, Signs and Symptoms

Criteria

6 inclusion criteria required to participate
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
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10 exclusion criteria prevent from participating
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
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

3 intervention groups are designated in this study

33.333% chance of being blinded to the placebo group

Treatment Groups

Group I

Placebo
Placebo injectable subcutaneously daily into the thigh or abdomen

Group II

Experimental
teduglutide 0.05 mg/kg/d

Group III

Experimental
teduglutide 0.1 mg/kg/d

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 32 locations

Suspended

Mayo Clinic Scottsdale

Scottsdale, United StatesOpen Mayo Clinic Scottsdale in Google Maps
Suspended

Georgetown University

Washington D.C., United States
Suspended

Emory University Hospital

Atlanta, United States
Suspended

Northwestern Center for Clinical Research

Chicago, United States
Completed32 Study Centers