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

Zeria Pharmaceutical

Status and phase

Enrolling

Phase 3

Conditions

Functional Dyspepsia

Treatments

Drug: Placebo

Drug: Acotiamide hydrochloride hydrate

Study type

Interventional

Funder types

Industry

Identifiers

NCT04526119

Z-338-07

Details and patient eligibility

About

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.

Enrollment

100 estimated patients

Sex

All

Ages

9 to 17 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Main Inclusion Criteria:

Part 1& Part 2

Subjects aged from nine to 17 years (from nine to 14 years in Part 1), on the day the informed consent is signed.
Subjects with a diagnosis of FD as defined by the Rome IV Criteria.
Subjects who have postprandial fullness, upper abdominal bloating or early satiation.

Part 2 only

Subjects who have postprandial fullness, upper abdominal bloating or early satiation during with a certain severity during a week prior to the day of randomization.

Main Exclusion Criteria:

Part 1&Part 2

Subject who have organic diseases of the gastrointestinal tract or gastrointestinal bleeding within 24 weeks prior to informed consent.
Subject who have received Helicobacter pylori eradication therapy within 24 weeks prior to informed consent, or subjects who is defined as Helicobacter pylori-positive within 4 weeks prior to or on the day the informed consent is signed.
Subjects who have alarm symptom on the day the informed consent is signed.
Subjects who have food allergy of unknown origin or uncontrolled food allergy.

Part 2 only

Subject taking drugs used for FD within 2 weeks prior to the day of randomization (excluding proton pump inhibitors)
Subject taking proton pump inhibitors within 4 weeks prior to the day of randomization.