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NCT05444543 · ClinicalTrials.gov registry record · Phase 4
Cycling of Topical Steroids for Treatment of EoE (Eosinopilic Esophagitis)
A Phase 4 study, sponsored by University Hospitals Cleveland Medical Center.
- Completed
- Registry status
- Phase 4
- Development phase
- 23
- Enrollment target
NCT05444543: Completed Phase 4 study, sponsored by University Hospitals Cleveland Medical Center.
NCT05444543 is a Phase 4 study that has completed, run by University Hospitals Cleveland Medical Center. The registered enrollment target is 23 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05444543, a Phase 4 study, has completed, sponsored by University Hospitals Cleveland Medical Center.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 23 participants
- Enrollment target
Study Summary
The purpose of our research study is to assess whether patients with EoE who have achieved control of their disease on topical Fluticasone or Budesonide are able to cycle or take breaks from their treatment with continued remission of their EoE. There will be 30 participants enrolled in this study. There will be 15 patients who will stay on steroid therapy every day and 15 patients who will cycle their steroid therapy on and off to help us compare the two groups. The cycling group will cycle their steroid therapy in a three-months on three-months off fashion.
Primary Outcome
The outcome measure is the number of participants who maintained remission (less than or equal to 15 eosinophils per high powered field in esophageal biopsies) for one year after demonstration of a therapeutic effect of topical steroid therapy.
Interventions
- DRUG Budesonide
- DRUG Fluticasone Propionate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 23 participants |
| Start Date | 2021-11-17 |
| Est. Completion | 2023-10-13 |
| Phase | Phase 4 |
What the finished NCT05444543 record still lists
NCT05444543 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 23 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (96% lower).
The record links to 0 conditions, and to 2 interventions - of which Budesonide is the first listed.
NCT05444543 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05444543 about?
NCT05444543 is a clinical study titled "Cycling of Topical Steroids for Treatment of EoE (Eosinopilic Esophagitis)". The purpose of our research study is to assess whether patients with EoE who have achieved control of their disease on topical Fluticasone or Budesonide are able to cycle or take breaks from their treatment with continued remission of their EoE. There will be 30 participants enrolled in this study. ...
What is the current status of trial NCT05444543?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 23 participants. The study started on 2021-11-17. Estimated completion is 2023-10-13.
What interventions are being tested in trial NCT05444543?
The interventions under investigation include: Budesonide (DRUG), Fluticasone Propionate (DRUG).
Who is sponsoring clinical trial NCT05444543?
This trial is sponsored by University Hospitals Cleveland Medical Center, which has 230 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05444543's enrollment target sits among peer trials
23 1725th of 2000 higher than 270 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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