clinical trial · NCT04526119
A Phase III Trial of Z-338 in Paediatric Patients With Functional Dyspepsia
Functional DyspepsiaAcotiamide hydrochloride hydratePlacebo
brief 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.
started
Feb 22, 2021
primary completion
Mar 1, 2026
completion
Jun 1, 2026
last updated
Mar 18, 2026
official title
Z-338 Phase III Trial - Evaluation of Pharmacokinetics, Efficacy and Safety in Paediatric Patients With Functional Dyspepsia
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol