A Phase III Trial of Z-338 in Paediatric Patients With Functional Dyspepsia
Status:
Recruiting
Trial end date:
2025-04-01
Target enrollment:
Participant gender:
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.