Clinical Research Directory

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

Sponsor: Mahidol University

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

Official title: Potassium Competitive Acid Blocker (PCAB) Test-Guided vs Physiologic Test-Guided Treatment in Patients With Typical Reflux Symptoms: A Randomized Non-inferiority Trial

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