A Phase III Trial of Z-338 in Paediatric Patients With Functional Dyspepsia (NCT04526119)

01

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.

02

Conditions studied

Functional Dyspepsia

03

In context

Lead sponsor

Zeria Pharmaceutical is the lead sponsor of 22 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible: 9 Years to 17 Years
Sexes eligible: All
Accepts healthy volunteers: No

Eligibility criteria

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.

05

Study design

Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Double (Participant, Investigator)
Enrollment: 55 participants (actual)

Study arms

Experimental
Z-338
Drug: Acotiamide hydrochloride hydrate
Placebo comparator
Placebo
Drug: Placebo

Interventions

DrugAcotiamide hydrochloride hydrate
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
DrugPlacebo
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

06

What researchers measure

Primary outcomes

Cmax of single dose Z-338 before meal
Time frame: The 1 day of single dose
AUC up to 8 hours after administration of single dose Z-338 before meal
Time frame: The 1 day of single dose
Elimination rate of three symptoms (Postprandial fullness, Upper abdominal bloating and Early satiation)
Time frame: At week 4 of treatment or treatment discontinuation
Overall responder rate by the Overall Treatment Evaluation (OTE) scale
Time frame: At week 4 of treatment or treatment discontinuation

Secondary outcomes

Elimination rate of each symptom
Time frame: Weekly from the day of randomization to Week 8
Average severity score of each symptom
Time frame: Weekly from the day of randomization to Week 8
Worst severity score of each symptom
Time frame: Weekly from the day of randomization to Week 8
Weekly responder rate by the OTE scale
Time frame: Weekly from the day of randomization to Week 8
Incidence of adverse events
Time frame: 8-weeks study period
Incidence of adverse drug reactions
Time frame: 8-weeks study period

07

Study locations

1 site

Zeria Investigative Site
Matsumoto, Nagano, Japan

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jul 24, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID: NCT04526119
Lead sponsor: Zeria Pharmaceutical
Responsible party: Sponsor
First posted: Aug 25, 2020
Start date: Feb 22, 2021
Primary completion: Mar 2, 2026
Completion: May 8, 2026
Last update: Jul 24, 2026

Study contacts

Yuji Shibasaki

study director · Zeria Pharmaceutical

Oversight

FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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