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NCT00798967 · ClinicalTrials.gov registry record · Phase 3
Study of Teduglutide Effectiveness in Parenteral Nutrition (PN)-Dependent Short Bowel Syndrome (SBS) Subjects
A Phase 3 study, sponsored by Shire.
- Completed
- Registry status
- Phase 3
- Development phase
- 86
- Enrollment target
NCT00798967: Completed Phase 3 study, sponsored by Shire.
NCT00798967 is a Phase 3 study that has completed, run by Shire. The registered enrollment target is 86 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (89% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00798967, a Phase 3 study, has completed, sponsored by Shire.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 86 participants
- Enrollment target
Study Summary
Teduglutide is an investigative medicine being evaluated as a possible treatment for people with parenteral nutrition (PN) dependent Short Bowel Syndrome (SBS). Teduglutide is similar to a protein the body makes. When people have SBS, their bodies do not make enough of the protein and they have trouble getting nutrients and fluids from the food they eat and drink. This study was designed to provide evidence of efficacy, safety, and tolerability of teduglutide 0.05 mg/kg daily in SBS subjects.
Primary Outcome
Comparison of subjects treated with teduglutide to placebo who achieve a 20 to 100% reduction from baseline in weekly parenteral nutrition/intravenous fluid (PN/I.V.) volume at weeks 20 and 24.
Interventions
- DRUG placebo
- DRUG teduglutide
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 86 participants |
| Start Date | 2008-11-25 |
| Est. Completion | 2011-01-25 |
| Phase | Phase 3 |
What the finished NCT00798967 record still lists
NCT00798967 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 86 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (89% lower).
The record links to 0 conditions, and to 2 interventions - of which placebo is the first listed.
NCT00798967 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00798967 about?
NCT00798967 is a clinical study titled "Study of Teduglutide Effectiveness in Parenteral Nutrition (PN)-Dependent Short Bowel Syndrome (SBS) Subjects". Teduglutide is an investigative medicine being evaluated as a possible treatment for people with parenteral nutrition (PN) dependent Short Bowel Syndrome (SBS). Teduglutide is similar to a protein the body makes. When people have SBS, their bodies do not make enough of the protein and they have trou...
What is the current status of trial NCT00798967?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 86 participants. The study started on 2008-11-25. Estimated completion is 2011-01-25.
What interventions are being tested in trial NCT00798967?
The interventions under investigation include: placebo (DRUG), teduglutide (DRUG).
Who is sponsoring clinical trial NCT00798967?
This trial is sponsored by Shire, which has 245 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00798967's enrollment target sits among peer trials
86 1745th of 2000 higher than 254 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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
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