Efficacy of Potassium-Competitive Acid Blockers in Barrett's Esophagus (PCAB BE Study)
NCT07788742 · Status: NOT_YET_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 12
Last updated 2026-08-26
Summary
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.
Conditions
- Barrett Esophagus
Interventions
- DRUG
-
Potassium-Competitive Acid Blockers (PCABs)
Potassium -competitive acid blockers (PCABs) are a newer class of acid-suppressing medications more potent than PPIs, with a faster onset and longer duration of action. PCABs are FDA-approved.
Sponsors & Collaborators
-
Phathom Pharmaceuticals, Inc.
collaborator INDUSTRY -
University of North Carolina, Chapel Hill
lead OTHER
Principal Investigators
-
Nicholas Shaheen, MD, MPH · UNC Chapel Hill
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-08-31
- Primary Completion
- 2028-08-31
- Completion
- 2029-08-31
- FDA Drug
- Yes
Countries
- United States
Study Locations
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