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

PHASE3RecruitingINTERVENTIONAL
Enrollment

100

Participants

Timeline

Start Date

February 22, 2021

Primary Completion Date

March 31, 2026

Study Completion Date

June 30, 2026

Conditions
Functional Dyspepsia
Interventions
DRUG

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

DRUG

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

Trial Locations (1)

Unknown

RECRUITING

Zeria Investigative Site, Matsumoto

Sponsors
All Listed Sponsors
lead

Zeria Pharmaceutical

INDUSTRY