Vonoprazan Test for PPI Refractory GERD (NCT07437768) | Clinical Trial Compass
By InvitationNot Applicable
Vonoprazan Test for PPI Refractory GERD
Taiwan100 participantsStarted 2025-12-24
Plain-language 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.
Who can participate
Age range
20 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
All participants were evaluated using the following validated symptom questionnaires: The GERD Questionnaire