NCT04526119

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

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

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 55 (actual)
• Sponsor: Zeria Pharmaceutical · Industry
• Sex: All
• Age: 9 Years – 17 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Functional Dyspepsia

Interventions

Type	Name	Description
DRUG	Acotiamide 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
DRUG	Placebo	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

Timeline

• Start date: 2021-02-22
• Primary completion: 2026-03-01
• Completion: 2026-06-01
• First posted: 2020-08-25
• Last updated: 2026-03-18

Locations

1 site across 1 country: Japan