A Phase III Trial of Z-338 in Paediatric Patients With Functional Dyspepsia (NCT04526119) | Clinical Trial Compass
Active — Not RecruitingPhase 3
A Phase III Trial of Z-338 in Paediatric Patients With Functional Dyspepsia
Japan55 participantsStarted 2021-02-22
Plain-language 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.
Who can participate
Age range
9 Years – 17 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Cmax of single dose Z-338 before meal
Timeframe: The 1 day of single dose
2
AUC up to 8 hours after administration of single dose Z-338 before meal
Timeframe: The 1 day of single dose
3
Elimination rate of three symptoms (Postprandial fullness, Upper abdominal bloating and Early satiation)
Timeframe: At week 4 of treatment or treatment discontinuation
4
Overall responder rate by the Overall Treatment Evaluation (OTE) scale
Timeframe: At week 4 of treatment or treatment discontinuation