MedTrace Logo

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

NCT07707011 · Status: ENROLLING_BY_INVITATION · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2026-07-16

No results posted yet for this study

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

Conditions

  • GERD, Acid Reflux, Treatment

Interventions

DIAGNOSTIC_TEST

PCAB-test guided

All participants in PCAB-test guided group will receive vonoprazan 20 mg orally twice daily for 7 days

Sponsors & Collaborators

  • Mahidol University

    lead OTHER

Principal Investigators

  • Monthira Maneerattanaporn, MD · Mahidol University

  • Somchai Leelakusolvong, MD · Mahidol University

  • Tanawat Geeratragool, MD · Mahidol University

  • Siwakan Phuetphaichit, MD · Mahidol University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-03-18
Primary Completion
2027-03-31
Completion
2027-03-31

Countries

  • Thailand

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07707011 on ClinicalTrials.gov