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Antifungal Agent

Itraconazole for Barrett's Esophagus

Phase 1
Waitlist Available
Research Sponsored by University of Kansas Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 8-12 months after study initiation
Awards & highlights
No Placebo-Only Group

Summary

This trial will investigate if a drug can stop Barrett's esophagus from recurring after treatment, helping to prevent esophageal cancer and reduce complications.

Who is the study for?
This trial is for patients with Barrett's esophagus who may have low to high-grade dysplasia or early-stage cancer and are set for endoscopic treatment. They should be relatively active (ECOG 0-2). It's not for those unable to consent, with severe heart failure, liver issues, allergy to itraconazole, pregnant women, or those on certain other drugs.
What is being tested?
The study tests Itraconazole in capsule and solution forms as a preventive treatment against the recurrence of Barrett's Esophagus after initial successful therapy. The goal is to improve long-term outcomes by preventing relapse which could lead to cancer.
What are the potential side effects?
Itraconazole can cause side effects like allergic reactions, liver problems, heart failure symptoms worsening in those already diagnosed with CHF, potential interactions with other medications metabolized by CYP3A4 leading to increased toxicity or reduced efficacy.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~8-12 months after study initiation
This trial's timeline: 3 weeks for screening, Varies for treatment, and 8-12 months after study initiation for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Itraconazole
Secondary study objectives
Itraconazole
Effects of itraconazole on AKT pathway
Itraconazole
+2 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Active Control
Group I: Itraconazole in solution formActive Control1 Intervention
Participants in this arm will receive the solution form of itraconazole
Group II: Itraconazole in capsule formActive Control1 Intervention
Participants in this arm will receive the capsule form of itraconazole

Find a Location

Who is running the clinical trial?

University of Kansas Medical CenterLead Sponsor
510 Previous Clinical Trials
176,874 Total Patients Enrolled
University of Texas, Southwestern Medical Center at DallasOTHER
17 Previous Clinical Trials
21,205 Total Patients Enrolled

Media Library

Itraconazole (Antifungal Agent) Clinical Trial Eligibility Overview. Trial Name: NCT05609253 — Phase 1
Barrett's Esophagitis Research Study Groups: Itraconazole in solution form, Itraconazole in capsule form
Barrett's Esophagitis Clinical Trial 2023: Itraconazole Highlights & Side Effects. Trial Name: NCT05609253 — Phase 1
Itraconazole (Antifungal Agent) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05609253 — Phase 1
~3 spots leftby Nov 2025
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