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NCT00081458 · ClinicalTrials.gov registry record · Phase 3
Safety and Efficacy Study of Teduglutide in Subjects With Short Bowel Syndrome
A Phase 3 study of Short Bowel Syndrome, sponsored by Shire.
- Completed
- Registry status
- Phase 3
- Development phase
- 84
- Enrollment target
- 20
- Study locations
NCT00081458 is a Phase 3 study of Short Bowel Syndrome that has completed, run by Shire. The registered enrollment target is 84 participants, below the 180-participant average among 17 other Short Bowel Syndrome trials with a reported enrollment target (53% lower). The trial reports 20 study locations across 15 states.
The verdict
NCT00081458, a Phase 3 study of Short Bowel Syndrome, has completed, sponsored by Shire.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 84 participants
- Enrollment target
- 20
- Study locations
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 |
Interested in This Trial?
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, categorized as Phase 3. The registered enrollment target is 84 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 180-participant average among 17 other Short Bowel Syndrome trials with a reported enrollment target (53% lower). The listed sponsor is Shire, which has 245 total studies on file at ClinicalTrials.gov.
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.
NCT00081458 reports 20 study locations spanning 15 distinct geographic areas - top geographies include New York, Pennsylvania, Other.
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.
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).
Who is sponsoring clinical trial NCT00081458?
This trial is sponsored by Shire, which has 245 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
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Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.