drugset / Trial / NCT07437768

Vonoprazan Test for PPI Refractory GERD

NCT07437768

Enrolling by invitation 100 enrolled Fu Jen Catholic University Hospital
NaSingle-groupOpen-labelTreatment

Summary

Among patients suffering from gastroesophageal reflux disease (GERD) symptoms, esophageal pH monitoring and the assessment of symptom-reflux correlation can identify two distinct subgroups characterized by normal acid exposure: functional heartburn and reflux hypersensitivity. Given the absence of abnormal acid exposure in these groups, conventional antacid therapies often yield unsatisfactory clinical outcomes. Therefore, in cases of PPI-refractory GERD, it is hypothesized that patients with underlying abnormal acid reflux will respond to Vonoprazan, a more potent potassium-competitive acid blocker (P-CAB). Conversely, those whose symptoms are unrelated to acid reflux are expected to show poor response. For future refractory patients without definitive endoscopic evidence of GERD (such as Los Angeles Grade B, C, or D esophagitis, peptic stricture, or histologically confirmed Barrett's esophagus), a Vonoprazan therapeutic trial could potentially bypass the need for invasive high-resolution manometry (HRM) and 24-hour pH-impedance monitoring. Evaluating the efficacy of Vonoprazan may offer diagnostic insights while minimizing patient discomfort and reducing overall healthcare expenditures.

Timeline

Start
2025-12-24
Primary completion
2026-02-09
Completion
2026-10-28

Drugs

EvaluationDrugModalityDoseRoute
Subject Vonoprazan Other / unclassified 20 mg Oral