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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 weeks3 visits
Treatment ~ Varies
Follow Up ~ 8-12 months after study initiation
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~8-12 months after study initiation
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 moreAwards & 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
517 Previous Clinical Trials
177,288 Total Patients Enrolled
University of Texas, Southwestern Medical Center at DallasOTHER
17 Previous Clinical Trials
21,205 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Rewritten Criteria:
- You cannot understand and agree to participate in the study.
- You have severe heart failure.
- Your liver function tests are three times higher than normal.
- You are allergic to itraconazole.
- You are pregnant.
- Your heart's electrical system has a prolonged QTc, which can be dangerous.
- The medication you are taking interacts badly with the study drug.
Research Study Groups:
This trial has the following groups:- Group 1: Itraconazole in solution form
- Group 2: Itraconazole in capsule form
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.