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

Z-338 Phase III Trial - Evaluation of Pharmacokinetics, Efficacy and Safety in Paediatric Patients With Functional Dyspepsia

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.

Study Overview

• Status: Recruiting
• Conditions: Functional Dyspepsia
• Intervention / Treatment: Drug: Acotiamide hydrochloride hydrate; Drug: Placebo

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Zeria R&D; Phone Number: +81-35644-7053; Email: kikaku@zeria.co.jp

Study Locations

• Japan
  • Nagano
    • Matsumoto, Nagano, Japan
      • Recruiting
      • Zeria Investigative Site
      • Contact: Zeria Investigative PI; Phone Number: +81-35644-7053

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 7 years to 15 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	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
Experimental: Z-338	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Cmax of single dose Z-338 before meal	The 1 day of single dose
AUC up to 8 hours after administration of single dose Z-338 before meal	The 1 day of single dose
Elimination rate of three symptoms (Postprandial fullness, Upper abdominal bloating and Early satiation)	At week 4 of treatment or treatment discontinuation
Overall responder rate by the Overall Treatment Evaluation (OTE) scale	At week 4 of treatment or treatment discontinuation

Secondary Outcome Measures

Outcome Measure	Time Frame
Elimination rate of each symptom	Weekly from the day of randomization to Week 8
Average severity score of each symptom	Weekly from the day of randomization to Week 8
Worst severity score of each symptom	Weekly from the day of randomization to Week 8
Weekly responder rate by the OTE scale	Weekly from the day of randomization to Week 8
Incidence of adverse events	8-weeks study period
Incidence of adverse drug reactions	8-weeks study period

Collaborators and Investigators

• Sponsor: Zeria Pharmaceutical
• Investigators: Study Director: Tomoharu Miyagawa, Zeria Pharmaceutical

Study record dates

Study Major Dates

• Study Start (Actual): February 22, 2021
• Primary Completion (Anticipated): February 1, 2025
• Study Completion (Anticipated): April 1, 2025

Study Registration Dates

• First Submitted: August 19, 2020
• First Submitted That Met QC Criteria: August 24, 2020
• First Posted (Actual): August 25, 2020

Study Record Updates

• Last Update Posted (Actual): October 12, 2022
• Last Update Submitted That Met QC Criteria: October 11, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Dyspepsia; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Cholinergic Agents; Enzyme Inhibitors; Gastrointestinal Agents; Cholinesterase Inhibitors; Z 338
• Other Study ID Numbers: Z-338-07

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No