Functional DyspepsiaPhase 3NCT04526119
A Phase III Trial of Z-338 in Paediatric Patients With Functional Dyspepsia
A Phase 3 study testing Acotiamide hydrochloride hydrate in people with Functional Dyspepsia, run by Zeria Pharmaceutical at 1 site in Japan.
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. Read more about this study
- Who is it for?
- Ages 9 to 17 years
- Conditions the study is for
- Functional Dyspepsia
- What is being tested?
- Acotiamide hydrochloride hydrate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 55 participants
- Where
- 1 siteJapan
- Study dates
- 22 Feb 2021to 8 May 2026
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 9 to 17 years
- All sexes
- No healthy volunteers
- Child
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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Z-338 Phase III Trial - Evaluation of Pharmacokinetics, Efficacy and Safety in Paediatric Patients With Functional Dyspepsia
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.
- Conditions
- Functional Dyspepsia
- Being tested
- Acotiamide hydrochloride hydrate, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acotiamide hydrochloride hydrateDrug
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
PlaceboDrug
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
| Study group | Role | What they receive |
|---|---|---|
| Z-338 | Experimental | Not described Receives: Drug: Acotiamide hydrochloride hydrate |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax of single dose Z-338 before meal
Measured: The 1 day of single dose
AUC up to 8 hours after administration of single dose Z-338 before meal
Measured: The 1 day of single dose
Elimination rate of three symptoms (Postprandial fullness, Upper abdominal bloating and Early satiation)
Measured: At week 4 of treatment or treatment discontinuation
Overall responder rate by the Overall Treatment Evaluation (OTE) scale
Measured: At week 4 of treatment or treatment discontinuation
Secondary outcomes (6)
Elimination rate of each symptom
Measured: Weekly from the day of randomization to Week 8
Average severity score of each symptom
Measured: Weekly from the day of randomization to Week 8
Worst severity score of each symptom
Measured: Weekly from the day of randomization to Week 8
Weekly responder rate by the OTE scale
Measured: Weekly from the day of randomization to Week 8
Incidence of adverse events
Measured: 8-weeks study period
Incidence of adverse drug reactions
Measured: 8-weeks study period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2020
- Study start22 Feb 2021
- Primary completion2 Mar 2026
- Study completion8 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Functional DyspepsiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zeria Pharmaceutical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yuji Shibasaki, Study director, Zeria Pharmaceutical
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04526119
- Sponsor's protocol ID
- Z-338-07
- Status last verified
- Jul 2026
- First submitted
- 19 Aug 2020
- Last updated
- 24 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Z-338 Phase III Trial - Evaluation of Pharmacokinetics, Efficacy and Safety in Paediatric Patients With Functional Dyspepsia
- ClinicalTrials.gov ID
- NCT04526119
- Acronym / sponsor ID
- Z-338-07
- Conditions
- Functional Dyspepsia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Zeria PharmaceuticalIndustry (pharma, biotech, devices)
- Study start
- 22 Feb 2021 (actual)
- Primary completion
- 2 Mar 2026 (actual)
- Study completion
- 8 May 2026 (actual)
- First posted
- 25 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Z-338 | Experimental | Drug: Acotiamide hydrochloride hydrate |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 9 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acotiamide hydrochloride hydrateA 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 | Drug | Z-338 |
| PlaceboA 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 | Drug | Placebo |
Primary outcome
Cmax of single dose Z-338 before meal
Time frame: The 1 day of single dose
AUC up to 8 hours after administration of single dose Z-338 before meal
Time frame: The 1 day of single dose
Elimination rate of three symptoms (Postprandial fullness, Upper abdominal bloating and Early satiation)
Time frame: At week 4 of treatment or treatment discontinuation
Overall responder rate by the Overall Treatment Evaluation (OTE) scale
Time frame: At week 4 of treatment or treatment discontinuation
6 secondary outcomes
Elimination rate of each symptom
Time frame: Weekly from the day of randomization to Week 8
Average severity score of each symptom
Time frame: Weekly from the day of randomization to Week 8
Worst severity score of each symptom
Time frame: Weekly from the day of randomization to Week 8
Weekly responder rate by the OTE scale
Time frame: Weekly from the day of randomization to Week 8
Incidence of adverse events
Time frame: 8-weeks study period
Incidence of adverse drug reactions
Time frame: 8-weeks study period
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yuji Shibasaki study director
Zeria Pharmaceutical
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Acotiamide hydrochloride hydrate in people with Functional Dyspepsia, run by Zeria Pharmaceutical at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cmax of single dose Z-338 before meal (time frame: The 1 day of single dose). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2026.