A Phase III Trial of Z-338 in Paediatric Patients With Functional Dyspepsia

Last updated: March 17, 2026
Sponsor: Zeria Pharmaceutical
Overall Status: Active - Not Recruiting

Phase

3

Condition

Functional Dyspepsia

Heartburn (Pediatric)

Bowel Dysfunction

Treatment

Placebo

Acotiamide hydrochloride hydrate

Clinical Study ID

NCT04526119
Z-338-07
  • Ages 9-17
  • All Genders

Study Summary

The purpose of this study is to evaluate pharmacokinetics, efficacy and safety of Z-338 of pediatric patients with functional dyspepsia (FD).

In Part 1, the pharmacokinetics and safety of single oral dose of Z-338 100 mg are evaluated.

In Part 2, the efficacy and safety of Z-338 100 mg orally 3 times daily before meals are evaluated.

Part 2 is comprised by the double-blind phase and the open-label phase. In the double-blind phase, subjects will take Z-338 or placebo for 28 days. In the open-label phase, all subjects will take Z-338 for 28 days.

Eligibility Criteria

Inclusion

Main Inclusion Criteria:

Part 1& Part 2

  • Subjects aged from nine to 17 years (from nine to 14 years in Part 1), on the daythe informed consent is signed.

  • Subjects with a diagnosis of FD as defined by the Rome IV Criteria.

  • Subjects who have postprandial fullness, upper abdominal bloating or earlysatiation.

Part 2 only

  • Subjects who have postprandial fullness, upper abdominal bloating or early satiationduring with a certain severity during a week prior to the day of randomization.

Exclusion

Main Exclusion Criteria:

Part 1&Part 2

  • Subject who have organic diseases of the gastrointestinal tract or gastrointestinalbleeding within 24 weeks prior to informed consent.

  • Subject who have received Helicobacter pylori eradication therapy within 24 weeksprior to informed consent, or subjects who is defined as Helicobacterpylori-positive within 4 weeks prior to or on the day the informed consent issigned.

  • Subjects who have alarm symptom on the day the informed consent is signed.

  • Subjects who have food allergy of unknown origin or uncontrolled food allergy.

Part 2 only

  • Subject taking drugs used for FD within 2 weeks prior to the day of randomization (excluding proton pump inhibitors)

  • Subject taking proton pump inhibitors within 4 weeks prior to the day ofrandomization.

Study Design

Total Participants: 55
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 3
Study Start date:
February 22, 2021
Estimated Completion Date:
June 30, 2026

Connect with a study center

  • Zeria Investigative Site

    Matsumoto, Nagano
    Japan

    Site Not Available

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