NCT07437768

Vonoprazan Test for PPI Refractory GERD

Vonoprazan Test for Proton Pump Inhibitor Refractory Gastroesophageal Reflux Disease

• Status: Enrolling By Invitation
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Fu Jen Catholic University Hospital · Academic / Other
• Sex: All
• Age: 20 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Refractory GERD
• NERD
• PCAB

Interventions

Type	Name	Description
DRUG	Patients received a 4-week treatment of vonoprazan 20 mg once daily (VOCINTI®)	Participants undergoing HRM and 24-hour pH-impedance monitoring were enrolled after providing informed consent. Baseline GERD-related questionnaires were administered on the day of the procedure. Patients then received a 4-week treatment of vonoprazan 20 mg once daily (VOCINTI®). After four weeks, patients returned for a follow-up visit to review their diagnostic reports and complete a second set of questionnaires. Final treatment strategies were adjusted according to the test findings.

Timeline

• Start date: 2025-12-24
• Primary completion: 2026-02-09
• Completion: 2026-10-28
• First posted: 2026-02-27
• Last updated: 2026-02-27

Locations

1 site across 1 country: Taiwan