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?
This trial is for adults (18+) with Barrett's Esophagus without dysplasia, confirmed by endoscopy in the past 3 years, who have been on daily acid-reducing medication (PPI) for at least 3 months. Participants must be able to take pills and follow study instructions. People with certain medical conditions or recent surgeries cannot join.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
PPI Treatment
Participants continue their current PPI medication once daily for at least 7 days, followed by a 24-hour pH impedance test
PCAB Treatment
Participants switch to Vonoprazan once daily for 7-28 days, followed by a second 24-hour pH impedance test
Follow-up
Participants are monitored for safety and effectiveness after treatment with a follow-up visit approximately 30 days after the last dose of Vonoprazan
What Are the Treatments Tested in This Trial?
Interventions
- Vonoprazan
Trial Overview
The study compares a new pill called Vonoprazan (a potassium-competitive acid blocker) to standard PPI treatment in reducing stomach acid in people with Barrett's Esophagus. Participants switch from their usual PPI to Vonoprazan and undergo tests before and after the change.
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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