Clinical trial · Interventional
Efficacy of Potassium-Competitive Acid Blockers in Barrett's Esophagus (PCAB BE Study)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Barrett Esophagus | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Potassium-Competitive Acid Blockers (PCABs) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Proton Pump Inhibitors (PPI) to Potassium-Competitive Acid Blockers (PCABs)
- description
- 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.
- interventionNames
- Drug: Potassium-Competitive Acid Blockers (PCABs)
Primary outcomes (1)
- measure
- Difference in percent time with pH<4 during 24-hour pH monitoring on PPI and PCAB therapies. (Normal is <4.0%)
- timeFrame
- Visit 2 (1 day after Baseline through 1 day prior to PCAB switch), Visit 3 (7-28 days after switching to PCAB)
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria:
* 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).
* 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
Exclusion Criteria:
* 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:
* 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.References
Publications (0)
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