Recruiting
Phase 4

Vonoprazan

Sponsor:

University of North Carolina, Chapel Hill

Code:

NCT07788742

Conditions

Barrett Esophagus

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Potassium-Competitive Acid Blockers (PCABs)

Study Details

Brief 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.

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

Barrett Esophagus

Study ID

NCT07788742

Start date

Nov, 2026

Status verified date

Oct, 2026

Completion date

Aug 31, 2029

Anticipated

Primary completion date

Aug 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

12 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

other: Proton Pump Inhibitors (PPI) to 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.

Interventions

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.

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) ]

Central Contacts and Locations

Central contacts

Shilpa Karanjit, MPH

919-843-8519shilpa_karanjit@med.unc.edu

Susan E Moist, MPH

919-918-5900susan_moist@med.unc.edu

Locations

University of North carolina at Chapel Hill

Recruiting

Chapel Hill, North Carolina, United States, 27599

Contacts

Shilpa Karanjit, MPH

+1 (919) 843-8519shilpa_karanjit@med.unc.edu

More Information

Sponsor

University of North Carolina, Chapel Hill

Last update posted

Nov 5, 2026

Last verified

Oct, 2026

Keywords

  • barrett esophagus

Trial information was received from ClinicalTrials.gov and was last updated on 2026-11-06. This information was provided to ClinicalTrials.gov by University of North Carolina, Chapel Hill on 2026-11-05. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.