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New acid blocker vonaprazan takes on esomeprazole in reflux healing showdown

NCT ID NCT06953986

Disease control Sponsor: Asian Institute of Gastroenterology, India Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
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 Results may not be published yet.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

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study compares two doses of vonaprazan (10 mg and 20 mg) with esomeprazole 40 mg for healing moderate to severe reflux esophagitis (grades B, C, or D) over 8 weeks. About 414 adults with GERD symptoms for at least 4 weeks will be randomly assigned to one of the three groups. The main goal is to see which treatment heals the esophagus better, and researchers will also track symptom improvement and side effects.

What this could mean

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

Active substance
vonaprazan (a stomach acid blocker) and esomeprazole (a proton pump inhibitor)
What this could lead to
If successful, vonaprazan could offer a new option for healing severe acid reflux damage, possibly working faster or better than current standard treatments.
What could go wrong
This is a relatively small, early-phase trial without a placebo group, so results may not apply to all patients. Both drugs are already approved for similar uses, so the benefit over existing options may be modest.

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

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 414 people

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

Started

Dec 2025

Expected to finish

Dec 2027

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 to 75 years

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 ≥18 years of age. * Endoscopically confirmed LA grade B, C, or D reflux esophagitis. * GERD symptoms (heartburn, regurgitation) for at least 4 weeks prior to enrollment. * Willing to provide informed consent and comply with study procedures. Exclusion Criteria: * Previous or ongoing treatment with Vonaprazan or Esomeprazole in the last 4 weeks. * Prior esophageal surgery or radiation therapy. * Barrett's esophagus, esophageal stricture, or malignancy. * Pregnant or breastfeeding women. * History of PPI-refractory GERD or severe gastroparesis. * Significant hepatic or renal impairment (ALT/AST \>3× ULN, eGFR \<30 mL/min). * Use of NSAIDs, steroids, or anticoagulants affecting healing.

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Conditions

The condition(s) this trial relates to.

gastroesophageal reflux disease peptic esophagitis

As listed by the trial registrant

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

GERD

How to take part

Only the study team decides who joins. These are the ways to reach them.

  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.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Asian Institute of Gastroenterology /Aig Hospitals

    RECRUITING

    Hyderabad, Telangana, 500082, India

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