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NCT02682381 · ClinicalTrials.gov registry record · Phase 3
Short Bowel Syndrome Research Study for Children Up To 17 Years of Age on Parenteral Nutrition
A Phase 3 study, sponsored by Shire.
- Completed
- Registry status
- Phase 3
- Development phase
- 59
- Enrollment target
NCT02682381: Completed Phase 3 study, sponsored by Shire.
NCT02682381 is a Phase 3 study that has completed, run by Shire. The registered enrollment target is 59 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (92% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02682381, a Phase 3 study, has completed, sponsored by Shire.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 59 participants
- Enrollment target
Study Summary
Teduglutide is approved for treatment of adults with short bowel syndrome (SBS). The purpose of this study is to evaluate the safety and efficacy of teduglutide in children up to the age of 17 with SBS who are dependent on parenteral support. Subjects may choose whether to receive the study drug or to participate in a standard-of-care arm. All participants who complete the study may be eligible to receive the study drug in a long-term extension study.
Primary Outcome
Reduction in weight-normalized PN/IV volume was performed using both participant diary and investigator prescribed data. Number of participants who achieved at least a 20% reduction in weight-normalized PN/IV volume between the baseline and week 24/EOT visit were reported.
Interventions
- OTHER Standard of Care
- DRUG Teduglutide 0.05mg/kg
- DRUG Teduglutide 0.025 mg/kg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 59 participants |
| Start Date | 2016-06-23 |
| Est. Completion | 2017-08-18 |
| Phase | Phase 3 |
What the finished NCT02682381 record still lists
NCT02682381 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 59 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (92% lower).
The record links to 0 conditions, and to 3 interventions - of which Standard of Care is the first listed.
NCT02682381 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02682381 about?
NCT02682381 is a clinical study titled "Short Bowel Syndrome Research Study for Children Up To 17 Years of Age on Parenteral Nutrition". Teduglutide is approved for treatment of adults with short bowel syndrome (SBS). The purpose of this study is to evaluate the safety and efficacy of teduglutide in children up to the age of 17 with SBS who are dependent on parenteral support. Subjects may choose whether to receive the study drug or ...
What is the current status of trial NCT02682381?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 59 participants. The study started on 2016-06-23. Estimated completion is 2017-08-18.
What interventions are being tested in trial NCT02682381?
The interventions under investigation include: Standard of Care (OTHER), Teduglutide 0.05mg/kg (DRUG), Teduglutide 0.025 mg/kg (DRUG).
Who is sponsoring clinical trial NCT02682381?
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 NCT02682381's enrollment target sits among peer trials
59 1824th of 2000 higher than 176 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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