NCT07788742|Not Yet RecruitingPhase 4FDA Drug
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Sponsor study identifier
interventional
12
1 country
1
Study Start
August 31, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
August 31, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
August 31, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
August 31, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 17, 2026
Actual (reported)August 26, 2026
Actual (reported)August 31, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
August 31, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
August 31, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
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.
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.
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.
Visit 2 (1 day after Baseline through 1 day prior to PCAB switch), Visit 3 (7-28 days after switching to PCAB)
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.
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
University of North carolina at Chapel Hill
Chapel Hill, North Carolina, 27599, United States
Nicholas Shaheen, MD, MPH
UNC Chapel Hill
First Submitted
August 17, 2026
First Posted
August 26, 2026
Study Start
August 31, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
August 31, 2028
EstimatedBarrett's Esophagus - 315 - 3 Way Cross Over
Detection of Barrett s Esophagus in Patients Without GERD Symptoms
Contact the study team to confirm eligibility.
Planned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
August 31, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
August 26, 2026
Record last verified: 2026-08
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Source: ClinicalTrials.gov.
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