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NCT03866538 · ClinicalTrials.gov registry record · Phase 4
Budesonide in Patients With Immune Mediated Enteropathies
A Phase 4 study, sponsored by Mayo Clinic.
- Terminated
- Registry status
- Phase 4
- Development phase
- 1
- Enrollment target
NCT03866538: Clinical Trial Phase 4 study, sponsored by Mayo Clinic.
NCT03866538 is a Phase 4 study that was terminated before completion, run by Mayo Clinic. The registered enrollment target is 1 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (100% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03866538, a Phase 4 study, was terminated before completion, sponsored by Mayo Clinic.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 1 participants
- Enrollment target
Study Summary
Researchers are trying to determine if withdrawal of budesonide therapy in patients with immune-mediated enteropathies doing well on therapy will result in worsening symptoms, histology, quality of life, and micronutrient/nutritional status when compared to continued therapy.
Primary Outcome
Investigators will determine change in small bowel villi after withdrawal of budesonide compared to continued therapy to assess small intestinal injury. This will be accomplished by esophagogastroduodenoscopy (upper scope) with biopsies from the small intestine.
Interventions
- DRUG Withdrawal of Oral Budesonide
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1 participants |
| Start Date | 2019-09-10 |
| Est. Completion | 2021-10-19 |
| Phase | Phase 4 |
Why NCT03866538 stopped before completion
NCT03866538 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 1 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (100% lower).
The record links to 0 conditions, and to 1 intervention - of which Withdrawal of Oral Budesonide is the first listed.
NCT03866538 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03866538 about?
NCT03866538 is a clinical study titled "Budesonide in Patients With Immune Mediated Enteropathies". Researchers are trying to determine if withdrawal of budesonide therapy in patients with immune-mediated enteropathies doing well on therapy will result in worsening symptoms, histology, quality of life, and micronutrient/nutritional status when compared to continued therapy.
What is the current status of trial NCT03866538?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 1 participants. The study started on 2019-09-10. Estimated completion is 2021-10-19.
What interventions are being tested in trial NCT03866538?
The interventions under investigation include: Withdrawal of Oral Budesonide (DRUG).
Who is sponsoring clinical trial NCT03866538?
This trial is sponsored by Mayo Clinic, which has 2,844 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03866538's enrollment target sits among peer trials
1 2000th of 2000 the lowest of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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