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

Authors
Category Primary study
Registry of Trialsclinicaltrials.gov
Year 2021
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.
Epistemonikos ID: f8b849cce88e63b086a81e7d35efd6a6e429c08f
First added on: May 07, 2024