drugset / Trial / NCT05609253

Itraconazole to Prevent Recurrent Barrett's Esophagus

NCT05609253

RandomizedSingle-groupOpen-labelPrevention

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

Timeline

Start
2022-09-14
Primary completion
2024-02-23
Completion
2026-12-30

Drugs

EvaluationDrugModalityDoseRoute
Comparator Itraconazole Small molecule

Indications