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New hope for kids with chronic upset stomach: drug trial shows promise

NCT ID NCT04526119

Symptom relief Sponsor: Zeria Pharmaceutical Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jul 24, 2026 · Updated 1 time

Summary

This study tests a medicine called Z-338 in children aged 9 to 17 who have functional dyspepsia, a condition causing stomach pain and fullness after eating. The trial has two parts: first checking how the drug moves through the body, then comparing it to a placebo over 28 days to see if it eases symptoms. All participants then receive the drug for another 28 days. The goal is to find a safe and effective treatment for this common childhood digestive issue.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

55 people

The number who actually took part.

Started

Feb 2021

Finished

May 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

9 to 17 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

dyspepsia functional gastric disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Functional dyspepsia

Contacts and locations

Locations

  • Zeria Investigative Site

    Matsumoto, Nagano, Japan

More trials for these conditions

Other studies related to the condition(s) this trial covers.