Vonoprazan Test for PPI Refractory GERD

NCT07437768 | Enrolling By Invitation

• 1 other identifier: PCAB for GERD
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• The Reflux Symptom Index (RSI)

  4 weeks

• The 5-item Brief Symptom Rating Scale (BSRS-5)

  4 weeks

• The Pittsburgh Sleep Quality Index (PSQI)

  4 weeks

Study Arms (1)

single arm. All patient received Vonoprazan

OTHER

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®)

Interventions

Patients received a 4-week treatment of vonoprazan 20 mg once daily (VOCINTI®) DRUG

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.

single arm. All patient received Vonoprazan

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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,

Sponsors & Collaborators

• Fu Jen Catholic University Hospital: lead

Study Sites (1)

Fu Jen Catholic University Hospital

New Taipei City, Taiwan, 24352, Taiwan

Location

MeSH Terms

Conditions

Gastroesophageal Reflux

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 12, 2026
• First Posted: February 27, 2026
• Study Start: December 24, 2025
• Primary Completion: February 9, 2026
• Study Completion (Estimated): October 28, 2026
• Last Updated: February 27, 2026

Record last verified: 2026-01

Locations

TW (1)