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New acid blocker takes on standard drug for Post-Surgery reflux

NCT ID NCT06955520

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 tests whether a newer acid-reducing drug, Vonaprazan, heals acid reflux better than the standard drug Esomeprazole in people who had POEM surgery for achalasia. About 300 adults with moderate to severe esophagitis will take one of the two drugs for 8 weeks. The goal is to see which drug heals the esophagus more effectively and improves symptoms like heartburn.

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 potassium-competitive acid blocker) and Esomeprazole (a proton pump inhibitor)
What this could lead to
If Vonaprazan works better, it could offer a more effective way to heal acid reflux after POEM surgery, reducing symptoms and the need for stronger treatments.
What could go wrong
This is a relatively small, early-stage comparison. Vonaprazan may not prove significantly better than the standard drug, and results may not apply to all GERD patients.

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 300 people

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

Started

Apr 2025

Expected to finish

Dec 2028

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: * Age ≥18 years * History of POEM for achalasia * Endoscopic confirmation of LA grade B, C, or D reflux esophagitis at 3 months post-POEM * GERD symptoms (heartburn, regurgitation) for ≥4 weeks * Willingness to provide informed consent and comply with study procedures Exclusion Criteria: * History of prior anti-reflux surgery * Presence of Barrett's esophagus, esophageal stricture, or malignancy * Severe gastroparesis or esophageal motility disorder unrelated to achalasia * Pregnancy or breastfeeding * Severe hepatic or renal impairment (ALT/AST \>3× ULN, eGFR \<30 mL/min) * Regular use of NSAIDs, steroids, or anticoagulants affecting esophageal 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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