Clinical Research Directory
Browse clinical research sites, groups, and studies.
A Phase III Trial of Z-338 in Paediatric Patients With Functional Dyspepsia
Sponsor: Zeria Pharmaceutical
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.
Official title: Z-338 Phase III Trial - Evaluation of Pharmacokinetics, Efficacy and Safety in Paediatric Patients With Functional Dyspepsia
Key Details
Gender
All
Age Range
9 Years - 17 Years
Study Type
INTERVENTIONAL
Enrollment
55
Start Date
2021-02-22
Completion Date
2026-06
Last Updated
2026-03-18
Healthy Volunteers
No
Conditions
Interventions
Acotiamide hydrochloride hydrate
A white film-coated tablet containing 100 mg Z-338 Administered orally, one tablet a time and three times a day before meals for 28 days in the double-blind phase Administered orally, one tablet a time and three times a day before meals for 28 days in the open-label phase
Placebo
A white film-coated tablet not containing 100 mg Z-338 Administered orally, one tablet a time and three times a day before meals for 28 days in the double-blind phase
Locations (1)
Zeria Investigative Site
Matsumoto, Nagano, Japan