A Phase 4 interventional study of Potassium-Competitive Acid Blockers (PCABs) in Barrett Esophagus, sponsored by University of North Carolina, Chapel Hill. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-05.
Sponsored by University of North Carolina, Chapel Hill · Phase 4, Interventional, and Treatment
This is a research study to look at how a new medication compares to standard treatment for reducing acid reflux in patients with Barrett's Esophagus. The study drug is Vonoprazan. This is a pill that is not yet FDA-approved for this purpose in this patient population.
The participants will first continue their current acid-reducing medicine (PPI) once a day for at least 7 days. After that, they will have a test to measure acid levels in their esophagus (food tube) while still taking the PPI medication. After this test, they will stop their current PPI medication and start taking the study drug, Vonoprazan, once a day for 7-28 days. They will then have a second acid test while on the study drug (Vonoprazan).
Before each test, the participants will complete a short questionnaire about their symptoms. The study team will collect their health history, including medical conditions and current medications. After they finish the study drug, they will have a follow-up visit in about 30 days. The participation in the study will then end.
This is a prospective open-label study of PCAB in adults aged 18 years or older with nondysplastic Barrett's esophagus (NDBE) on maintenance PPI therapy. At the time of enrollment, participants will continue their usual PPI (any brand), standardized to once daily dosing for at least 7 days. After ≥7 days on once daily dosing, participants will undergo ambulatory 24-hour pH impedance testing without interruption of PPI therapy. After pH testing is complete, PPIs will be discontinued and replaced with vonoprazan 20 mg once daily for 7-28 days. After ≥7 days, 24-hour pH impedance testing will be repeated without interruption of vonoprazan therapy. Participants will complete a 30 day safety follow-up after the last dose of vonoprazan. Following completion of the follow-up visit, the patient's participation in the trial will end. Safety will be monitored throughout the study via assessing adverse events and conducting pregnancy and liver function testing.
Participants will complete the validated Gastroesophageal Reflux Disease-Health Related Quality of Life (GERD-HRQL) questionnaire prior to each pH study to assess symptom burden. Additionally, a health history questionnaire assessing comorbidities, concurrent medications, and past acid suppressive regimens, will be collected.
PPIs and PCABs are FDA-approved but their efficacy has not been compared in the NDBE sub-group enrolled on this study, an open-label prospective cohort without a control arm is the most appropriate and feasible study design as the study aims to compare two treatment methods in the same participant. Because participants will be used as their own comparator, a placebo arm is not needed. Furthermore, maintenance of patients with known BE on a placebo may induce reflux esophagitis.
312 studies on the registry are indexed under Barrett Esophagus; 60 are open to participants now.
This study's planned enrollment of 12 is below the median of 62 across 187 interventional studies indexed under Barrett Esophagus.
Browse Barrett Esophagus studies →University of North Carolina, Chapel Hill is the lead sponsor of 1,372 studies on the registry; 133 are open to participants now.
Of its 161 completed or terminated interventional studies of FDA-regulated products, 139 (86%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Diagnosed with nondysplastic Barrett's Esophagus (NBDE) defined as meeting the following within the past 3 years:
Exclusion Criteria:
Current to 24hr pH impedance test, including:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
All participants will be enrolled while receiving PPI. After participant has been on a once daily PPI therapry regimen for at least 7 days, a 24-hour ph impedance test will be conducted while still receiving PPI medication. Participants will then be switched to PCABs for 7-28 days. A second 24-hour ph impedance test will be conducted by Day 28 while participants are taking PCABs.
Drug: Potassium-Competitive Acid Blockers (PCABs)
Potassium -competitive acid blockers (PCABs) are a newer class of acid-suppressing medications more potent than PPIs, with a faster onset and longer duration of action. PCABs are FDA-approved.
Difference in percent time with pH<4 during 24-hour pH monitoring on PPI and PCAB therapies. (Normal is <4.0%)
24 hour pH impedance testing is a routine clinical care procedure that is often conducted in this patient population as part of their ongoing care and maintenance of their condition to analyze reflux events. The test is minimally invasive. Participant's esophageal pH level is measured by completing 24 hour impedance test on visits 2 and 3. The participants will be on PPI during their first impedance test and they will be on vonoprazan during their second impedance test. The findings of this test will be used to calculate the difference in percent time with pH\<4 during 24-hour pH monitoring.
Time frame: Visit 2 (1 day after Baseline through 1 day prior to PCAB switch), Visit 3 (7-28 days after switching to PCAB)
Difference in reflux symptom severity scores as measured by the GERD-HRQL questionnaire.
The Gastroesophageal Reflux Disease-Health Related Quality of Life (GERD-HRQL) questionnaire is a patient-reported measure of GERD symptom severity and disease-specific quality of life. The total score is calculated by summing item scores, yielding a possible range of 0 to 50. Higher scores represent greater symptom burden and poorer GERD-related quality of life; lower scores represent symptom improvement and better quality of life.
Time frame: Visit 2 (1 day after Baseline through 1 day prior to PCAB switch), Visit 3 (7-28 days after switching to PCAB)
Difference in percent time with pH<5 during 24-hour pH monitoring.
24 hour pH impedance testing is a routine clinical care procedure that is often conducted in this patient population as part of their ongoing care and maintenance of their condition to analyze reflux events. The test is minimally invasive. Participant's esophageal pH level is measured by completing 24 hour impedance test on visits 2 and 3. The participants will be on PPI during their first impedance test and they will be on vonoprazan during their second impedance test. The findings of this test will be used to calculate the difference in percent time with pH\<5 during 24-hour pH monitoring.
Time frame: Visit 2 (1 day after Baseline through 1 day prior to PCAB switch), Visit 3 (7-28 days after switching to PCAB)
Difference in mean pH during 24-hr pH monitoring.
24 hour pH impedance testing is a routine clinical care procedure that is often conducted in this patient population as part of their ongoing care and maintenance of their condition to analyze reflux events. The test is minimally invasive. Participant's esophageal pH level is measured by completing 24 hour impedance test on visits 2 and 3. The participants will be on PPI during their first impedance test and they will be on vonoprazan during their second impedance test. The findings of this test will be used to calculate the difference in mean pH during 24-hour pH monitoring.
Time frame: Visit 2 (1 day after Baseline through 1 day prior to PCAB switch), Visit 3 (7-28 days after switching to PCAB)
Plan to share: No
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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