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.
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.
Endoscopically confirmed BE with segment length ≥2 cm (to avoid those with an irregular Z line), and
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.
Single group
Potassium-Competitive Acid Blockers (PCABs)
DrugPotassium -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.
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.
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.
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.
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University of North Carolina, Chapel Hill
Lead sponsor
Phathom Pharmaceuticals, Inc.
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
