Evaluating Z-338 for treating functional dyspepsia in children

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

This study is testing a new medication called Z-338 to see if it can help children aged 9 to 17 with functional dyspepsia feel better and if it's safe for them to use.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 100 (estimated)
• Ages: 9 Years to 17 Years
• Sex: All
• Sponsor: Zeria Pharmaceutical (Industry-sponsored)
• Locations: 1 site (Matsumoto, Nagano)
• Trial ID: NCT04526119 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to assess the pharmacokinetics, efficacy, and safety of Z-338 in pediatric patients aged 9 to 17 years diagnosed with functional dyspepsia. The study is divided into two parts: the first part evaluates the pharmacokinetics and safety of a single oral dose of Z-338, while the second part examines the efficacy and safety of Z-338 taken three times daily for 28 days in a double-blind and open-label format. Participants will be monitored for symptoms such as postprandial fullness and upper abdominal bloating throughout the trial.

Who should consider this trial

Good fit: Ideal candidates are children aged 9 to 17 years with a diagnosis of functional dyspepsia as per the Rome IV Criteria.

Not a fit: Patients with organic gastrointestinal diseases or those who have recently undergone Helicobacter pylori eradication therapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve the quality of life for children suffering from functional dyspepsia.

How similar studies have performed: While there have been studies on treatments for functional dyspepsia, the specific approach of using Z-338 in this pediatric population is novel.

Eligibility criteria

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.

Where this trial is running

Matsumoto, Nagano

• Zeria Investigative Site — Matsumoto, Nagano, Japan (Recruiting)

Study contacts

• Study coordinator: Zeria Clinical Project Management

Conditions Functional Dyspepsia