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

Functional Dyspepsia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04526119
• Other study ID #: Z-338-07
• Status: Recruiting
• Phase: Phase 3
• Start date: February 22, 2021
• Est. completion date: April 2025

Study information

• Verified date: October 2022
• Source: Zeria Pharmaceutical
• Contact: Zeria R&D
• Phone: +81-35644-7053
• Email: kikaku[@]zeria.co.jp
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: April 2025
• Est. primary completion date: February 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 9 Years to 17 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dyspepsia
• Functional Dyspepsia

Intervention

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
• 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

Locations

Country	Name	City	State
Japan	Zeria Investigative Site	Matsumoto	Nagano

Sponsors (1)

Lead Sponsor	Collaborator
Zeria Pharmaceutical

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cmax of single dose Z-338 before meal		The 1 day of single dose
Primary	AUC up to 8 hours after administration of single dose Z-338 before meal		The 1 day of single dose
Primary	Elimination rate of three symptoms (Postprandial fullness, Upper abdominal bloating and Early satiation)		At week 4 of treatment or treatment discontinuation
Primary	Overall responder rate by the Overall Treatment Evaluation (OTE) scale		At week 4 of treatment or treatment discontinuation
Secondary	Elimination rate of each symptom		Weekly from the day of randomization to Week 8
Secondary	Average severity score of each symptom		Weekly from the day of randomization to Week 8
Secondary	Worst severity score of each symptom		Weekly from the day of randomization to Week 8
Secondary	Weekly responder rate by the OTE scale		Weekly from the day of randomization to Week 8
Secondary	Incidence of adverse events		8-weeks study period
Secondary	Incidence of adverse drug reactions		8-weeks study period