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

CompletedPhase 3

Sponsor: Zeria Pharmaceutical

Conditions: Functional Dyspepsia

Interventions: Acotiamide hydrochloride hydrate, Placebo

Countries: Japan

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.

Eligibility overview

Sex: ALL

Age: 9 Years to 17 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility 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.

Locations (1)

Matsumoto, Nagano, Japan