Vonoprazan Test for PPI Refractory GERD

Vonoprazan Test for Proton Pump Inhibitor Refractory Gastroesophageal Reflux Disease

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Refractory GERD; NERD; PCAB
• Intervention / Treatment: Drug: Patients received a 4-week treatment of vonoprazan 20 mg once daily (VOCINTI®)

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Taiwan
    • New Taipei City, Taiwan, Taiwan, 24352
      • Fu Jen Catholic University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients aged between 20 and 75 years.
• Outpatients at Fu Jen Catholic University Hospital who had undergone esophagogastroduodenoscopy (EGD) within the past year.
• Presence of persistent GERD symptoms, including acid regurgitation, heartburn, chest pain, globus sensation, or chronic cough. PPI-refractory GERD, defined as persistent symptoms despite receiving at least 8 weeks of standard-dose proton pump inhibitor (PPI) therapy (GerdQ > = 8).
• Scheduled to undergo high-resolution manometry (HRM) and 24-hour esophageal pH-impedance monitoring.
• Patients with a history of any grade of erosive esophagitis confirmed by gastroscopy.

Exclusion Criteria:

• major esophageal motility disorders
• history of upper gastrointestinal surgery
• malignant tumors
• liver cirrhosis.
• esophageal strictures
• esophageal varices
• gastrointestinal obstruction
• significant acute GI bleeding
• LA Grade B, C, or D erosive esophagitis,
• esophageal peptic stricture
• biopsy-proven Barrett's esophagus
• severe renal impairment (CrCl < 30 mL/min)
• long-term dialysis, pregnancy
• hypersensitivity to vonoprazan or its excipients.
• patients currently taking atazanavir sulfate or rilpivirine hydrochloride,
• dependent on tube feeding
• unable to cooperate due to impaired consciousness

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: single arm. All patient received Vonoprazan; Patients scheduled for high-resolution manometry (HRM) and 24-hour esophageal pH-impedance monitoring due to GERD symptoms were invited to participate in this study. Following the attainment of informed consent, participants completed a series of GERD-related questionnaires on the day of their examination. Subsequently, they were prescribed a 4-week course of VOCINTI®, a potassium-competitive acid blocker (P-CAB), at a daily oral dose of vonoprazan 20 mg. At the 4-week follow-up visit, the clinical reports for HRM and 24-hour pH-impedance monitoring were reviewed. During this visit, patients completed the GERD-related questionnaires for a second time. Subsequent therapeutic management was then determined based on the comprehensive diagnostic results.

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
All participants were evaluated using the following validated symptom questionnaires: The GERD Questionnaire	The GERD Questionnaire (GerdQ) includes 4 positive predictors (heartburn, regurgitation, reflux-related sleep disturbance, and use of over-the-counter medications) and 2 negative predictors (epigastric pain and nausea) for GERD. The GerdQ score ranges from 0 to 18. A higher score indicates a higher probability of GERD and a greater symptom burden. A cutoff score of 8 or higher is generally used to identify patients with a high likelihood of having GERD.	4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Reflux Symptom Index (RSI)	The Reflux Symptom Index (RSI) consists of 9 items (e.g., hoarseness, frequent throat clearing, and globus sensation), each rated on a scale from 0 (no problem) to 5 (severe) based on the severity of symptoms. Minimum score: 0 Maximum score: 45	4 weeks
The 5-item Brief Symptom Rating Scale (BSRS-5)	The BSRS-5 score ranges from 0 to 20. A higher score indicates greater psychological distress. The 5-item Brief Symptom Rating Scale (BSRS-5) was used to screen for common psychiatric conditions, such as anxiety and depression; a score ≥ 6 indicates potential psychological morbidity.	4 weeks
The Pittsburgh Sleep Quality Index (PSQI)	The Pittsburgh Sleep Quality Index (PSQI) is a 7-item self-rated questionnaire used to assess sleep quality over the preceding month; a global PSQI score > 5 indicates poor sleep quality or sleep disturbance. The PSQI global score ranges from 0 to 21. A higher score indicates poorer sleep quality.	4 weeks

Collaborators and Investigators

• Sponsor: Fu Jen Catholic University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 24, 2025
• Primary Completion (Actual): February 9, 2026
• Study Completion (Estimated): October 28, 2026

Study Registration Dates

• First Submitted: February 12, 2026
• First Submitted That Met QC Criteria: February 24, 2026
• First Posted (Actual): February 27, 2026

Study Record Updates

• Last Update Posted (Actual): February 27, 2026
• Last Update Submitted That Met QC Criteria: February 24, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Esophageal Diseases; Esophageal Motility Disorders; Deglutition Disorders; Gastroesophageal Reflux
• Other Study ID Numbers: PCAB for GERD

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No