機能性消化不良の小児患者を対象としたZ-338の第III相臨床試験

基本情報

NCT ID

NCT04526119

ステータス

募集中

試験のフェーズ

第3相

試験タイプ

介入

目標被験者数

100

治験依頼者名

Zeria Pharmaceutical

概要

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.

対象疾患

介入

依頼者（Sponsor）