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ACTIVE NOT RECRUITING
NCT04526119
PHASE3

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

Sponsor: Zeria Pharmaceutical

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

9 Years - 17 Years

Study Type

INTERVENTIONAL

Enrollment

55

Start Date

2021-02-22

Completion Date

2026-06

Last Updated

2026-03-18

Healthy Volunteers

No

Interventions

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

Locations (1)

Zeria Investigative Site

Matsumoto, Nagano, Japan