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NCT05587673 · ClinicalTrials.gov registry record · Phase 1
High Dose Steroid Therapy to Treat Flares in Patients With Inflammatory Bowel Disease (IBD)
A Phase 1 study, sponsored by Stanford University.
- Completed
- Registry status
- Phase 1
- Development phase
- 3
- Enrollment target
NCT05587673: Completed Phase 1 study, sponsored by Stanford University.
NCT05587673 is a Phase 1 study that has completed, run by Stanford University. The registered enrollment target is 3 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05587673, a Phase 1 study, has completed, sponsored by Stanford University.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 3 participants
- Enrollment target
Study Summary
This study will examine whether delivery of high dose steroids, directly into the inflamed bowel via its arterial blood supply, will be better for treating uncontrolled flares of inflammatory bowel disease in patients compared to conventional intra-venous or oral administration of this drug. Patients aged 4-25 years of age will be recruited. In this study, the Investigator hopes to also learn how this directed steroid delivery during an active flare will improve patient symptoms as well as the appearance of inflamed segments of bowel determined by imaging or biopsy (i.e. at the time of endoscopy). Additional data will determine how the blood vessels in the bowel affect, and potentially even drive the mechanisms, of inflammatory bowel disease.
Primary Outcome
Number of patients who have symptomatic, imaging or biopsy related improvement in their IBD symptoms following locoregional intraarterial methylprednisolone administration into the affected segment of bowel.
Interventions
- DRUG Methylprednisolone
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3 participants |
| Start Date | 2022-10-06 |
| Est. Completion | 2024-10-11 |
| Phase | Phase 1 |
What the finished NCT05587673 record still lists
NCT05587673 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 3 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (95% lower).
The record links to 0 conditions, and to 1 intervention - of which Methylprednisolone is the first listed.
NCT05587673 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05587673 about?
NCT05587673 is a clinical study titled "High Dose Steroid Therapy to Treat Flares in Patients With Inflammatory Bowel Disease (IBD)". This study will examine whether delivery of high dose steroids, directly into the inflamed bowel via its arterial blood supply, will be better for treating uncontrolled flares of inflammatory bowel disease in patients compared to conventional intra-venous or oral administration of this drug. Patient...
What is the current status of trial NCT05587673?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 3 participants. The study started on 2022-10-06. Estimated completion is 2024-10-11.
What interventions are being tested in trial NCT05587673?
The interventions under investigation include: Methylprednisolone (DRUG).
Who is sponsoring clinical trial NCT05587673?
This trial is sponsored by Stanford University, which has 1,744 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05587673's enrollment target sits among peer trials
3 1999th of 2000 higher than 1 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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