Refractory GERDNCT07437768
Vonoprazan Test for PPI Refractory GERD
A study testing Patients received a 4-week treatment of vonoprazan 20 mg once daily (VOCINTI®) in people with Refractory GERD and NERD, run by Fu Jen Catholic University Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Refractory GERD, NERD, PCAB
- What is being tested?
- Patients received a 4-week treatment of vonoprazan 20 mg once daily (VOCINTI®)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteTaiwan
- Study dates
- 24 Dec 2025to 28 Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- major esophageal motility disorders
- history of upper gastrointestinal surgery
- malignant tumors
- liver cirrhosis.
- esophageal strictures
- esophageal varices
Show all 17Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site
Fu Jen Catholic University Hospital
New Taipei City, Taiwan, 24352
About this study
Official title: 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.
- Conditions
- Refractory GERD, NERD, PCAB
- Being tested
- Patients received a 4-week treatment of vonoprazan 20 mg once daily (VOCINTI®)
- Medical subject headings
- Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Patients received a 4-week treatment of vonoprazan 20 mg once daily (VOCINTI®) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 weeks
Secondary outcomes (3)
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
Measured: 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.
Measured: 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.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2026
- Study start24 Dec 2025
- Primary completion9 Feb 2026
- Study completion28 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Refractory GERDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fu Jen Catholic University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07437768
- Sponsor's protocol ID
- PCAB for GERD
- Status last verified
- Jan 2026
- First submitted
- 12 Feb 2026
- Last updated
- 27 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vonoprazan Test for Proton Pump Inhibitor Refractory Gastroesophageal Reflux Disease
- ClinicalTrials.gov ID
- NCT07437768
- Acronym / sponsor ID
- PCAB for GERD
- Conditions
- Refractory GERD, NERD, PCAB
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Fu Jen Catholic University HospitalUniversity, hospital or other
- Study start
- 24 Dec 2025 (actual)
- Primary completion
- 9 Feb 2026 (actual)
- Study completion
- 28 Oct 2026 (estimated)
- First posted
- 27 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| single arm. All patient received Vonoprazan | Other | Drug: Patients received a 4-week treatment of vonoprazan 20 mg once daily (VOCINTI®)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. |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (17 listed)
- major esophageal motility disorders
- history of upper gastrointestinal surgery
- malignant tumors
- liver cirrhosis.
- esophageal strictures
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Drug | single arm. All patient received Vonoprazan |
Primary outcome
All participants were evaluated using the following validated symptom questionnaires: The GERD Questionnaire
Time frame: 4 weeks
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.
3 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2026.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Patients received a 4-week treatment of vonoprazan 20 mg once daily (VOCINTI®) in people with Refractory GERD and NERD, run by Fu Jen Catholic University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 27 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
All participants were evaluated using the following validated symptom questionnaires: The GERD Questionnaire (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2026; AzTrials last refreshed its copy on 27 Oct 2026.