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Safety and Efficacy Study of Teduglutide in Subjects With Short Bowel Syndrome
NCT00081458 · View on ClinicalTrials.gov ↗
Study Summary
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).
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Teduglutide 0.05 mg/kg/d
- DRUG Teduglutide 0.1 mg/kg/d
Study Locations (20)
New York
- Albany Medical Center — Albany
- Mount Sinai School of Medicine — New York
- University of Rochester Medical Center — Rochester
Pennsylvania
- University of Pennsylvania - Penn Nursing — Philadelphia
- University of Pittsburgh Medical Center — Pittsburgh
Other
- l'Hôpital Erasme — Brussels
- Rigshospitalet, University of Copenhagen — Copenhagen
Ontario
- St. Michael's Hospital — Toronto
- Toronto General Hospital — Toronto
Arizona
- Mayo Clinic Scottsdale — Scottsdale
District of Columbia
- Georgetown University — Washington D.C.
Georgia
- Emory University Hospital — Atlanta
Illinois
- Northwestern Center for Clinical Research — Chicago
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 84 participants |
| Start Date | 2004-05-25 |
| Est. Completion | 2007-07-06 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00081458
The ClinicalTrials.gov registry entry for NCT00081458 describes a study currently listed as completed. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 84 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Shire, which has 56 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Short Bowel Syndrome appearing as the primary indexed condition, and to 3 interventions — of which Placebo is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT00081458 reports 20 study locations spanning 15 distinct geographic areas — top geographies include New York, Pennsylvania, Other. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT00081458 about?
NCT00081458 is a clinical study titled "Safety and Efficacy Study of Teduglutide in Subjects With Short Bowel Syndrome". 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).
What is the current status of trial NCT00081458?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 84 participants. The study started on 2004-05-25. Estimated completion is 2007-07-06.
What conditions does trial NCT00081458 study?
This clinical trial studies the following conditions: Short Bowel Syndrome. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT00081458?
The interventions under investigation include: Placebo (DRUG), Teduglutide 0.05 mg/kg/d (DRUG), Teduglutide 0.1 mg/kg/d (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT00081458?
This trial is sponsored by Shire, which has 56 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT00081458 being conducted?
This trial has 20 study locations across Arizona, District of Columbia, Georgia, Illinois, Kansas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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