Potassium-Competitive Acid Blockers in Barrett’s Esophagus on PPI Therapy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is an open-label, phase 4 study evaluating vonoprazan 20 mg once daily for 7–28 days in adults with nondysplastic Barrett’s esophagus who are on maintenance PPI therapy. Participants first continue their PPI, undergo 24-hour pH impedance testing, then discontinue PPIs and start vonoprazan, followed by a second 24-hour pH impedance test. Symptom questionnaires and safety monitoring, including liver function tests and pregnancy checks, are performed throughout, with a final safety follow-up about 30 days after the last dose.

Why it matters

Who can join: the full rules

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.

Where it's running

• University of North carolina at Chapel Hill
  Chapel Hill, North Carolina, United States Recruiting

Study contacts

• Principal investigator: Nicholas Shaheen, MD, MPH — UNC Chapel Hill
• Study coordinator: Shilpa Karanjit, MPH
• Email: shilpa_karanjit@med.unc.edu
• Phone: 919-843-8519

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.