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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: Completed Phase 3 study of Short Bowel Syndrome, sponsored by Shire.
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. According to ClinicalTrials.gov, the official US trial registry.
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).
Primary Outcome
The intensity of the response relied on a reduction from Baseline in weekly parenteral nutrition (PN) volume (minimum reduction of 20% and a maximum of 100%). Duration of the response incorporated responses at Weeks(Wk) 16-20 and at Wk20-24. Zero (0 - lowest) assigned if \<20% reduction at Wk20-24 and reduction at Wk16-20 of \< 20%, 20-39%, or \>=40%. One (1) assigned if reduction of 20-39% at Wk20-24 but \< 20% at Wk16-20. Two(2) assigned if reductions of 40-99% at Wk20-24 AND \<20% at Wk16-20
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 |
What the finished NCT00081458 record still lists
NCT00081458 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 84 participants, a relatively small participant target, below the 180-participant average among 17 other Short Bowel Syndrome trials with a reported enrollment target (53% lower).
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 names 20 study sites across 15 states, led by 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
Similar trials for Short Bowel Syndrome
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00081458's enrollment target sits among peer trials
84 10th of 17 higher than 8 of 17 other Short Bowel Syndrome trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Short Bowel Syndrome trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
Efficacy And Safety Evaluation of Glepaglutide in Treatment of SBS
RECRUITING · Phase 3
-
Evaluation of Long Term Safety and Efficacy of Glepaglutide in Treatment of SBS
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Evaluation of Long Term Safety and Efficacy of Glepaglutide in Treatment of SBS - Extension Trial
ACTIVE NOT RECRUITING · Phase 3
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Open-label Extension Trial to Evaluate the Long-term Safety of Apraglutide in Short Bowel Syndrome.
ACTIVE NOT RECRUITING · Phase 3
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Trial to Evaluate Efficacy and Safety of Apraglutide in SBS-IF
COMPLETED · Phase 3
-
Long-term Safety and Efficacy Study of Teduglutide in Pediatric Participants With Short Bowel Syndrome (SBS)
COMPLETED · Phase 3
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