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Completed

NCT Number: NCT04526119

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

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.

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Key information

Conditions

Functional Dyspepsia

Age range

9 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Zeria Investigative Site

Matsumoto, Nagano, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Main Inclusion Criteria:

Part 1& Part 2

  • Subjects aged from nine to 17 years (from nine to 14 years in Part 1), on the day the 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 early satiation.

Part 2 only

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

Main Exclusion Criteria:

Part 1&Part 2

  • Subject who have organic diseases of the gastrointestinal tract or gastrointestinal bleeding within 24 weeks prior to informed consent.
  • Subject who have received Helicobacter pylori eradication therapy within 24 weeks prior to informed consent, or subjects who is defined as Helicobacter pylori-positive within 4 weeks prior to or on the day the informed consent is signed.
  • 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 of randomization.

Treatment and study plan

Acotiamide hydrochloride hydrate

Drug

A white film-coated tablet containing 100 mg Z-338 Administered orally, one tablet a time and three times a day before meals for 28 days in the double-blind phase Administered orally, one tablet a time and three times a day before meals for 28 days in the open-label phase

Placebo

Drug

A white film-coated tablet not containing 100 mg Z-338 Administered orally, one tablet a time and three times a day before meals for 28 days in the double-blind phase

Primary outcomes

  1. Cmax of single dose Z-338 before meal

    Time frame: The 1 day of single dose

  2. AUC up to 8 hours after administration of single dose Z-338 before meal

    Time frame: The 1 day of single dose

  3. Elimination rate of three symptoms (Postprandial fullness, Upper abdominal bloating and Early satiation)

    Time frame: At week 4 of treatment or treatment discontinuation

  4. Overall responder rate by the Overall Treatment Evaluation (OTE) scale

    Time frame: At week 4 of treatment or treatment discontinuation

Secondary outcomes

  1. Elimination rate of each symptom

    Time frame: Weekly from the day of randomization to Week 8

  2. Average severity score of each symptom

    Time frame: Weekly from the day of randomization to Week 8

  3. Worst severity score of each symptom

    Time frame: Weekly from the day of randomization to Week 8

  4. Weekly responder rate by the OTE scale

    Time frame: Weekly from the day of randomization to Week 8

  5. Incidence of adverse events

    Time frame: 8-weeks study period

  6. Incidence of adverse drug reactions

    Time frame: 8-weeks study period

Sponsors and collaborators

Lead sponsor

Zeria Pharmaceutical

Industry

Registry information

Official study title

Z-338 Phase III Trial - Evaluation of Pharmacokinetics, Efficacy and Safety in Paediatric Patients With Functional Dyspepsia

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Aug 25, 2020
Registry last updated
Jul 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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