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

NCT04526119 | Active Not Recruiting Phase 3

• 1 other identifier: Z-338-07
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (6)

• 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

Study Arms (2)

Z-338

EXPERIMENTAL

Drug: Acotiamide hydrochloride hydrate

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Acotiamide hydrochloride hydrate 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

Z-338

Placebo 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

Placebo

Eligibility Criteria

• Age: 9 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zeria Pharmaceutical: lead

Study Sites (1)

Zeria Investigative Site

Matsumoto, Nagano, Japan

Location

Study Officials

• Yuji Shibasaki

  Zeria Pharmaceutical

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 19, 2020
• First Posted: August 25, 2020
• Study Start: February 22, 2021
• Primary Completion: March 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: March 18, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

JP (1)