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

NCT ID: NCT04526119

Last Updated: 2024-07-03

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-02-22
• Study Completion Date: 2026-06-30

Brief 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.

Conditions

Functional Dyspepsia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Z-338

Group Type: EXPERIMENTAL

Acotiamide hydrochloride hydrate

Intervention Type: DRUG

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

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

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

Intervention Type: 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

Intervention Type: DRUG

Eligibility Criteria

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.

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.

• Minimum Eligible Age: 9 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zeria Pharmaceutical

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yuji Shibasaki

Role: STUDY_DIRECTOR

Zeria Pharmaceutical

Locations

Zeria Investigative Site

Matsumoto, Nagano, Japan

Site Status: RECRUITING

Countries

Japan

Central Contacts

Zeria Clinical Project Management

Role: CONTACT

338registry@zeria.co.jp

+81-33661-0276

Facility Contacts

Zeria Investigative PI

Role: primary

+81-35644-7053

Other Identifiers

Z-338-07

Identifier Type: -

Identifier Source: org_study_id