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

Phase 3

Recruiting

• Conditions: Functional Dyspepsia
• Interventions: Drug: Acotiamide hydrochloride hydrate; Drug: Placebo

• Registration Number: NCT04526119
• Lead Sponsor: Zeria Pharmaceutical

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-08-19
• Study First Submitted QC: 2020-08-24
• Study First Posted: 2020-08-25
• Study Start: 2021-02-22
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-01
• Last Update Posted: 2024-07-03
• Primary Completion: 2026-03
• Study Completion: 2026-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Z-338	Acotiamide hydrochloride hydrate	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
AUC up to 8 hours after administration of single dose Z-338 before meal	The 1 day of single dose
Cmax 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

Name	Time	Method
Incidence of adverse drug reactions	8-weeks study period
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

Trial Locations

Locations (1)

Zeria Investigative Site; 🇯🇵 Matsumoto, Nagano, Japan