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

NCT ID NCT03553563

Completed Disease control Sponsor: AstraZeneca Source: ClinicalTrials.gov ↗

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.

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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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