Potassium-Competitive Acid Blockers for Barrett's Esophagus
What You Need to Know Before You Apply
What is the purpose of this trial?
This is a research study to look at how a new medication compares to standard treatment for reducing acid reflux in patients with Barrett's Esophagus. The study drug is Vonoprazan. This is a pill that is not yet FDA-approved for this purpose in this patient population.
The participants will first continue their current acid-reducing medicine (PPI) once a day for at least 7 days. After that, they will have a test to measure acid levels in their esophagus (food tube) while still taking the PPI medication. After this test, they will stop their current PPI medication and start taking the study drug, Vonoprazan, once a day for 7-28 days. They will then have a second acid test while on the study drug (Vonoprazan).
Before each test, the participants will complete a short questionnaire about their symptoms. The study team will collect their health history, including medical conditions and current medications. After they finish the study drug, they will have a follow-up visit in about 30 days. The participation in the study will then end.
Who Is on the Research Team?
Nicholas Shaheen, MD, MPH
Principal Investigator
UNC Chapel Hill
Are You a Good Fit for This Trial?
Inclusion Criteria
Exclusion Criteria
What Are the Treatments Tested in This Trial?
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
All participants will be enrolled while receiving PPI. After participant has been on a once daily PPI therapry regimen for at least 7 days, a 24-hour ph impedance test will be conducted while still receiving PPI medication. Participants will then be switched to PCABs for 7-28 days. A second 24-hour ph impedance test will be conducted by Day 28 while participants are taking PCABs.
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of North Carolina, Chapel Hill
Lead Sponsor
Phathom Pharmaceuticals, Inc.
Industry Sponsor
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