Barrett EsophagusPhase 4NCT07788742
Efficacy of Potassium-Competitive Acid Blockers in Barrett's Esophagus (PCAB BE Study)
A Phase 4 study testing Potassium-Competitive Acid Blockers (PCABs) in people with Barrett Esophagus, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Barrett Esophagus
- What is being tested?
- Potassium-Competitive Acid Blockers (PCABs)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2026to 31 Aug 2029
- Phase
- Phase 4
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 18 or older at time of consent.
- Able to read and understand English and provide written informed consent.
- History of Gastroesophageal Reflux Disease (GERD) with or without heartburn.
- Diagnosed with nondysplastic Barrett's Esophagus (NBDE) defined as meeting the following within the past 3 years:
- Endoscopically confirmed BE with segment length ≥2 cm (to avoid those with an irregular Z line), and
- Histologic evidence of intestinal metaplasia without dysplasia ("dysplasia" includes indefinite for dysplasia).
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- Currently on proton pump inhibitor (PPI) maintenance therapy, defined as PPI prescribed once or twice daily for 3 or more months (defined as 90 days or more) from consent. Any formulation and dosage of PPI will be included, including pantoprazole, omeprazole, esomeprazole, lansoprazole, rabeprazole, dexlansoprazole or their generic equivalents.
- If currently on twice daily PPI, then able to modify PPI regimen to once daily dosing as part of their routine clinical care.
- Ability to take oral medication and willing to adhere to study intervention regimen.
- Willing to follow lifestyle recommendations as outlined in protocol section 5.3
Who cannot join
- Barrett's Esophagus (BE) with dysplasia (indefinite for dysplasia, or low-grade dysplasia, or high-grade dysplasia) diagnosed within 12 months of study entry.
- Current or prior esophageal adenocarcinoma (EAC).
- Use of other acid suppressive medications.
- H. pylori diagnosis or treatment within the past 6 months prior to study entry.
- History of upper gastrointestinal tract surgery (e.g., esophagectomy or surgery for reflux disease).
- Current contraindication to 24hr pH impedance test, including:
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- Recent broken nose, nasal surgery, or known deviated septum; or
- Bleeding disorders or those taking certain blood-thinning medications and unable to temporarily discontinue use per current clinical guidance may also be excluded due to increased risk of bleeding during catheter insertion; or
- Individuals with implanted devices like pacemakers or defibrillators.
- Known hypersensitivity or allergic reaction to any component of the study intervention.
- Treatment with another investigational product within 30 days prior to consent.
- Current use of rilpivirine-containing products.
- Pregnant, breastfeeding, or considering becoming pregnant or intending to donate ova during the study and for 30 days after the last dose of study drug.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of North carolina at Chapel Hill
Chapel Hill, North Carolina, 27599
Shilpa Karanjit, MPH, +1 (919) 843-8519, shilpa_karanjit@med.unc.edu
About this study
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.
Read the detailed description
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.
- Conditions
- Barrett Esophagus
- Being tested
- Potassium-Competitive Acid Blockers (PCABs)
- Keywords
- barrett esophagus
- Medical subject headings
- Barrett Esophagus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Potassium-Competitive Acid Blockers (PCABs)Drug
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.
| Study group | Role | What they receive |
|---|---|---|
| Proton Pump Inhibitors (PPI) to Potassium-Competitive Acid Blockers (PCABs) | Other | 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. Receives: Drug: Potassium-Competitive Acid Blockers (PCABs) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Visit 2 (1 day after Baseline through 1 day prior to PCAB switch), Visit 3 (7-28 days after switching to PCAB)
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: Visit 2 (1 day after Baseline through 1 day prior to PCAB switch), Visit 3 (7-28 days after switching to PCAB)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2026
- Study startNov 2026 (estimated)
- Primary completion31 Aug 2028 (estimated)
- Study completion31 Aug 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Barrett EsophagusStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- Phathom Pharmaceuticals, Inc.
- Responsible party
- Sponsor
- Investigators
- Nicholas Shaheen, MD, MPH, Principal investigator, UNC Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07788742
- Sponsor's protocol ID
- 25-2665
- Status last verified
- Oct 2026
- First submitted
- 17 Aug 2026
- Last updated
- 5 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Potassium-Competitive Acid Blockers in Barrett's Esophagus (PCAB BE Study)
- ClinicalTrials.gov ID
- NCT07788742
- Acronym / sponsor ID
- 25-2665
- Conditions
- Barrett Esophagus
- Keywords
- barrett esophagus
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- Phathom Pharmaceuticals, Inc.
- Study start
- Nov 2026 (estimated)
- Primary completion
- 31 Aug 2028 (estimated)
- Study completion
- 31 Aug 2029 (estimated)
- First posted
- 26 Aug 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.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Proton Pump Inhibitors (PPI) to Potassium-Competitive Acid Blockers (PCABs) | Other | Drug: Potassium-Competitive Acid Blockers (PCABs)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Adults aged 18 or older at time of consent.
- Able to read and understand English and provide written informed consent.
- History of Gastroesophageal Reflux Disease (GERD) with or without heartburn.
- Diagnosed with nondysplastic Barrett's Esophagus (NBDE) defined as meeting the following within the past 3 years:
- Currently on proton pump inhibitor (PPI) maintenance therapy, defined as PPI prescribed once or twice daily for 3 or more months (defined as 90 days or more) from consent. Any formulation and dosage of PPI will be included, including pantoprazole, omeprazole, esomeprazole, lansoprazole, rabeprazole, dexlansoprazole or their generic equivalents.
Key exclusion criteria (13 listed)
- Barrett's Esophagus (BE) with dysplasia (indefinite for dysplasia, or low-grade dysplasia, or high-grade dysplasia) diagnosed within 12 months of study entry.
- Current or prior esophageal adenocarcinoma (EAC).
- Use of other acid suppressive medications.
- H. pylori diagnosis or treatment within the past 6 months prior to study entry.
- History of upper gastrointestinal tract surgery (e.g., esophagectomy or surgery for reflux disease).
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 |
|---|---|---|
| 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. | Drug | Proton Pump Inhibitors (PPI) to Potassium-Competitive Acid Blockers (PCABs) |
Primary outcome
Difference in percent time with pH<4 during 24-hour pH monitoring on PPI and PCAB therapies. (Normal is <4.0%)
Time frame: Visit 2 (1 day after Baseline through 1 day prior to PCAB switch), Visit 3 (7-28 days after switching to PCAB)
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.
3 secondary outcomes
Difference in reflux symptom severity scores as measured by the GERD-HRQL questionnaire.
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.
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.
Time frame: Visit 2 (1 day after Baseline through 1 day prior to PCAB switch), Visit 3 (7-28 days after switching to PCAB)
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 5 Nov 2026.
- Individual participant dataSharing planned: No
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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.
Nicholas Shaheen, MD, MPH principal investigator
UNC Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Potassium-Competitive Acid Blockers (PCABs) in people with Barrett Esophagus, run by University of North Carolina, Chapel Hill at 1 site in United States.
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 10 inclusion and 13 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: looking for participants now, as of the sponsor's last update on 5 Nov 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 United States. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Contact Shilpa Karanjit, MPH (919-843-8519, shilpa_karanjit@med.unc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in percent time with pH<4 during 24-hour pH monitoring on PPI and PCAB therapies. (Normal is <4.0%) (time frame: Visit 2 (1 day after Baseline through 1 day prior to PCAB switch), Visit 3 (7-28 days after switching to PCAB)). 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 5 Nov 2026.