Clinical Trial

Potassium Competitive Acid Blocker (PCAB) Test-Guided vs Physiologic Test-Guided Treatment in Patients With Typical Reflux Symptoms

Enrolling by Invitation
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Summary
The goal of this clinical trial is to learn if a short course of a potassium-competitive acid blocker (PCAB) test can guide treatment of adults with typical reflux symptoms as effectively as standard physiologic testing with endoscopy and 24-hour pH-impedance monitoring. It will also learn about the safety of PCAB-guided management. The main questions it aims to answer are: * Is PCAB test-guided treatment as effective as physiologic test-guided treatment in improving reflux symptoms after 4 weeks? * How accurate is the PCAB test at detecting pathologic acid reflux compared with 24-hour pH-impedance monitoring? * What medical problems do participants have when receiving PCAB-, proton-pump inhibitor-, or neuromodulator-based treatment? * In this study, researchers will compare two strategies: one group will receive a 7-day course of vonoprazan (PCAB) as a diagnostic test and then treatment guided by the PCAB response, while the other group will undergo endoscopy and 24-hour pH-impedance monitoring with treatment guided by those results. Participants will: * Be randomly assigned to either the PCAB test-guided group or the physiologic test-guided group * Take study medicines by mouth (such as vonoprazan, omeprazole, and/or nortriptyline or matching placebos) for about 4 weeks, depending on their test results and symptom type * Attend scheduled clinic visits for checkups, questionnaires, and safety monitoring * Keep a diary of their reflux symptoms, quality of life, and any use of rescue antacid medicine
Trial Details
NCT Number NCT07707011
Lead Sponsor Mahidol University
Conditions GERD, Acid Reflux, Treatment
Enrollment 120 participants
Start Date 2026-03-18
Primary Completion 2027-03 (estimated)
Study Completion 2027-03 (estimated)
Updated on ClinicalTrials.gov 2026-07-16