New acid blocker may offer stronger reflux control for Barrett's esophagus

NCT ID NCT07788742

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Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
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Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

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Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 26, 2026 · Last updated Aug 27, 2026 · Updated 1 time

Summary

This study tests whether vonoprazan, a newer type of acid-suppressing medication, reduces acid reflux in the esophagus better than standard proton pump inhibitors (PPIs) in people with Barrett's esophagus. Participants will first take their usual PPI for a week, then switch to vonoprazan for 7-28 days. Acid levels in the esophagus will be measured during both treatments, and participants will report their reflux symptoms. The goal is to see if vonoprazan provides more effective acid control, which could help manage this condition.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Vonoprazan, a potassium-competitive acid blocker (PCAB), taken as a pill once daily.
What this could lead to
If effective, vonoprazan could offer better acid control than current PPIs for people with Barrett's esophagus, potentially reducing reflux-related damage and symptoms.
What could go wrong
This is a small, early-phase study (12 participants) and vonoprazan is not yet FDA-approved for this condition. Results may not apply to everyone, and the drug may not prove superior to standard treatment.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 12 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Aug 2026

An estimate. Start dates often move.

Expected to finish

Aug 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

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  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

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  3. A doctor treating you

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Contacts and locations

Locations

  • University of North carolina at Chapel Hill

    Chapel Hill, North Carolina, 27599, United States

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