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NCT05609253 · ClinicalTrials.gov registry record · Phase 1
Itraconazole to Prevent Recurrent Barrett's Esophagus
A Phase 1 study of Barrett Oesophagitis With Dysplasia, sponsored by University of Kansas Medical Center.
- Active
- Registry status
- Phase 1
- Development phase
- 10
- Enrollment target
- 1
- Study location
NCT05609253: Active Phase 1 study of Barrett Oesophagitis With Dysplasia, sponsored by University of Kansas Medical Center.
NCT05609253 is a Phase 1 study of Barrett Oesophagitis With Dysplasia that is active but no longer recruiting, run by University of Kansas Medical Center. The registered enrollment target is 10 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (83% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05609253, a Phase 1 study of Barrett Oesophagitis With Dysplasia, is active but no longer recruiting, sponsored by University of Kansas Medical Center.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 10 participants
- Enrollment target
- 1
- Study location
Study Summary
Recurrent Barrett's esophagus (BE) that occurs at the rate of 12.4%/year is the Achilles heel of the endoscopic treatment of high-risk BE. Over time, after eradication, BE ultimately recurs in as many as 30-50% of the patients putting them at risk for esophageal adenocarcinoma (EAC), thereby undoing the benefits of an effective initial therapy. Also, recurrences need retreatments that increase costs and complications including strictures and refractory ulcerations. A therapy to prevent recurrent BE does not currently exist. Itraconazole with its ability to inhibit important molecular pathways related to BE development could enhance the long-term effectiveness of endoscopic eradication of high-risk BE, thereby promoting a long-term cure
Primary Outcome
The primary endpoint will be the tissue (in esophageal biopsies) and blood concentrations of itraconazole.
Conditions Studied
Interventions
- DRUG Itraconazole in capsule form
- DRUG Itraconazole in solution form
Study Locations (1)
Kansas
- University of Kansas Medical Center - Kansas City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2022-09-14 |
| Est. Completion | 2026-06-30 |
| Phase | Phase 1 |
What the registry record for NCT05609253 still lists
NCT05609253 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (83% lower).
The record links to 1 condition, with Barrett Oesophagitis With Dysplasia appearing as the primary indexed condition, and to 2 interventions - of which Itraconazole in capsule form is the first listed.
NCT05609253 reports a single indexed study location in Kansas.
Frequently Asked Questions
What is clinical trial NCT05609253 about?
NCT05609253 is a clinical study titled "Itraconazole to Prevent Recurrent Barrett's Esophagus". Recurrent Barrett's esophagus (BE) that occurs at the rate of 12.4%/year is the Achilles heel of the endoscopic treatment of high-risk BE. Over time, after eradication, BE ultimately recurs in as many as 30-50% of the patients putting them at risk for esophageal adenocarcinoma (EAC), thereby undoing...
What is the current status of trial NCT05609253?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 10 participants. The study started on 2022-09-14. Estimated completion is 2026-06-30.
What conditions does trial NCT05609253 study?
This clinical trial studies the following conditions: Barrett Oesophagitis With Dysplasia.
What interventions are being tested in trial NCT05609253?
The interventions under investigation include: Itraconazole in capsule form (DRUG), Itraconazole in solution form (DRUG).
Who is sponsoring clinical trial NCT05609253?
This trial is sponsored by University of Kansas Medical Center, which has 408 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05609253 being conducted?
This trial has 1 study location across Kansas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05609253's enrollment target sits among peer trials
10 1913th of 2000 higher than 46 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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