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NCT00109473 · ClinicalTrials.gov registry record · Phase 2
Trial of Growth Hormone Therapy in Pediatric Crohn's Disease
A Phase 2 study, sponsored by Children's Hospital Medical Center, Cincinnati.
- Completed
- Registry status
- Phase 2
- Development phase
- 22
- Enrollment target
NCT00109473: Completed Phase 2 study, sponsored by Children's Hospital Medical Center, Cincinnati.
NCT00109473 is a Phase 2 study that has completed, run by Children's Hospital Medical Center, Cincinnati. The registered enrollment target is 22 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (83% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00109473, a Phase 2 study, has completed, sponsored by Children's Hospital Medical Center, Cincinnati.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 22 participants
- Enrollment target
Study Summary
The purpose of this study is to determine whether taking a growth hormone (GH) drug called somatropin causes the intestine of a person with Crohn's Disease (CD) to heal faster when compared to a person with Crohn's Disease that does not receive growth hormone drug.
Primary Outcome
The CDHIS was developed and validated in order to determine the effect of therapies upon histologic disease activity in Crohn's Disease. It has been used to assess mucosal healing in response to infliximab and 6-MP/AZA.It contains eight items which reflect epithelial injury, mucosal inflammation, and the extent of involvement. Scores range from 0-16, with patients with moderate to severely active CD typically having scores of 6-12. It was computed by a GI pathologist. The higher the score indica
Interventions
- DRUG growth hormone
- DRUG cortecosteroid
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 22 participants |
| Start Date | 2005-04 |
| Est. Completion | 2009-08 |
| Phase | Phase 2 |
What the finished NCT00109473 record still lists
NCT00109473 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 22 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (83% lower).
The record links to 0 conditions, and to 2 interventions - of which growth hormone is the first listed.
NCT00109473 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00109473 about?
NCT00109473 is a clinical study titled "Trial of Growth Hormone Therapy in Pediatric Crohn's Disease". The purpose of this study is to determine whether taking a growth hormone (GH) drug called somatropin causes the intestine of a person with Crohn's Disease (CD) to heal faster when compared to a person with Crohn's Disease that does not receive growth hormone drug.
What is the current status of trial NCT00109473?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 22 participants. The study started on 2005-04. Estimated completion is 2009-08.
What interventions are being tested in trial NCT00109473?
The interventions under investigation include: growth hormone (DRUG), cortecosteroid (DRUG).
Who is sponsoring clinical trial NCT00109473?
This trial is sponsored by Children's Hospital Medical Center, Cincinnati, which has 571 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00109473's enrollment target sits among peer trials
22 1790th of 2000 higher than 207 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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