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

Functional Dyspepsia Clinical Trial

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

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04526119
Study type Interventional
Source Zeria Pharmaceutical
Contact Zeria R&D
Phone +81-35644-7053
Email kikaku@zeria.co.jp
Status Recruiting
Phase Phase 3
Start date February 22, 2021
Completion date April 2025
View Details
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