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NCT05609253
Itraconazole to Prevent Recurrent Barrett's Esophagus
Phase 1 trial testing Itraconazole in capsule form in Barrett Oesophagitis With Dysplasia in 10 participants. Participants enrolled and being followed up; not accepting new ones.
23 February 2024
Quick facts
| Lead sponsor | University of Kansas Medical Center |
|---|---|
| Phase | Phase 1 |
| Status | Active, enrolled |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | single group |
| Masking | none |
| Primary purpose | prevention |
| Enrollment | 10 |
| Start date | 14 September 2022 |
| Primary completion | 23 February 2024 |
| Estimated completion | 30 June 2026 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Itraconazole in capsule form — full drug profile →
- Itraconazole in solution form
Conditions studied
- Barrett Oesophagitis With Dysplasia — all drugs for Barrett Oesophagitis With Dysplasia →
Sponsor
University of Kansas Medical Center
Who can join
18 and older, any sex, with Barrett Oesophagitis With Dysplasia. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05609253 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University of Kansas Medical Center
- Last refreshed: 8 August 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05609253.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing