Vonoprazan Test for PPI Refractory GERD
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Patients received a 4-week treatment of vonoprazan 20 mg once daily (VOCINTI®).
- Who it may be relevant to
- Registry conditions: Refractory GERD, NERD, PCAB. Basic parameters: 20 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Taiwan
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Vonoprazan Test for Proton Pump Inhibitor Refractory Gastroesophageal Reflux Disease
Overview
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.
Interventions
- 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.
Primary outcome measures
- All participants were evaluated using the following validated symptom questionnaires: The GERD Questionnaire [Time frame: 4 weeks]
Secondary outcome measures (3)
- The Reflux Symptom Index (RSI) [Time frame: 4 weeks]
- The 5-item Brief Symptom Rating Scale (BSRS-5) [Time frame: 4 weeks]
- The Pittsburgh Sleep Quality Index (PSQI) [Time frame: 4 weeks]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Taiwan · 1 center
- Fu Jen Catholic University Hospital — New Taipei City
Identifiers
NCT: NCT07437768 · PCAB for GERD