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Can a common acid reflux drug keep kids Ulcer-Free?

NCT ID NCT03553563

Disease control Sponsor: AstraZeneca Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 completed Phase 3 study tested the drug D961H (esomeprazole) in 50 Japanese children to see if it can prevent reflux esophagitis from coming back and stop stomach or duodenal ulcers from recurring in kids taking NSAIDs or low-dose aspirin. Children took the drug for up to 52 weeks, and researchers tracked relapses and side effects. The goal is to find a safe, effective long-term maintenance dose for pediatric patients.

What this could mean

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

Active substance
Esomeprazole (D961H)
What this could lead to
If successful, this could confirm a safe and effective maintenance dose of esomeprazole for Japanese children to prevent relapse of reflux esophagitis and stomach ulcers.
What could go wrong
This is a small, completed Phase 3 study in Japanese children only, so results may not apply to other populations. Long-term safety data is limited to 52 weeks.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

50 people

The number who actually took part.

Started

Jul 2018

Finished

Dec 2022

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

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

Ages

1 year to 14 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: For healed reflux esophagitis study * Endoscopically verified reflux esophagitis, Grade A or higher according to the Los Angels classification as judged by central evaluation committee. For prevention of gastric ulcer or duodenal ulcer recurrence study * Patients with documented medical history of gastric ulser or duodenal ulser diagnosis based on upper gastrointestinal symptoms, fecal occult blood, esophagogastroduodenoscopy findings, etc. Exclusion Criteria: * Patients less than 10 kg in weight. * Use of any other investigational compounds or participations in another clinical trial within 4 weeks prior to the enrolment. * Significant clinical illness within 4 weeks prior to the informed consent * Previous total gastrectomy. * Presence of hepatic diseases or other conditions that could interfere with evaluation of the study as judged by investigators. etc.

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Conditions

The condition(s) this trial relates to.

duodenal ulcer gastric ulcer peptic esophagitis

As listed by the trial registrant

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

Duodenal ulcer Gastric ulcer Reflux esophagitis

Contacts and locations

Locations

  • Research Site

    Bunkyō City, 113-8431, Japan

  • Research Site

    Bunkyō City, 113-8519, Japan

  • Research Site

    Fuji-shi, 417-8567, Japan

  • Research Site

    Izumi-shi, 594-1101, Japan

  • Research Site

    Kagoshima, 890-8520, Japan

  • Research Site

    Kanazawa, 920-8641, Japan

  • Research Site

    Maebashi, 371-8511, Japan

  • Research Site

    Matsumoto-shi, 390-8621, Japan

  • Research Site

    Okayama, 701-1192, Japan

  • Research Site

    Sakaishi, 593-8304, Japan

  • Research Site

    Setagaya-ku, 157-8535, Japan

  • Research Site

    Shinjuku-ku, 160-0023, Japan

  • Research Site

    Takatsuki-shi, 569-8686, Japan

  • Research Site

    Yokohama, 230-8765, Japan

  • Research Site

    Yokohama, 232 8555, Japan

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