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Itraconazole to Prevent Recurrent Barrett's Esophagus

NCT05609253 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2025-08-08

No results posted yet for this 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

Conditions

  • Barrett Oesophagitis With Dysplasia

Interventions

DRUG

Itraconazole in capsule form

Patients with high-risk BE will receive two weeks of itraconazole in the capsule form (N=5).

DRUG

Itraconazole in solution form

Patients with high-risk BE will receive two weeks of itraconazole in the solution form (N=5).

Sponsors & Collaborators

  • University of Texas, Southwestern Medical Center at Dallas

    collaborator OTHER

  • University of Kansas Medical Center

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-09-14
Primary Completion
2024-02-23
Completion
2026-06-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05609253 on ClinicalTrials.gov