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

Study Overview
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Brief Summary
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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.

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

Conditions
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Functional Dyspepsia

Intervention / Treatment
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* Drug: Acotiamide hydrochloride hydrate
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 9 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Z-338<br> | Drug: Acotiamide hydrochloride hydrate<br>* 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<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cmax of single dose Z-338 before meal |  | The 1 day of single dose | 
| AUC up to 8 hours after administration of single dose Z-338 before meal |  | The 1 day of single dose | 
| Elimination rate of three symptoms (Postprandial fullness, Upper abdominal bloating and Early satiation) |  | At week 4 of treatment or treatment discontinuation | 
| Overall responder rate by the Overall Treatment Evaluation (OTE) scale |  | At week 4 of treatment or treatment discontinuation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Elimination rate of each symptom |  | Weekly from the day of randomization to Week 8 | 
| Average severity score of each symptom |  | Weekly from the day of randomization to Week 8 | 
| Worst severity score of each symptom |  | Weekly from the day of randomization to Week 8 | 
| Weekly responder rate by the OTE scale |  | Weekly from the day of randomization to Week 8 | 
| Incidence of adverse events |  | 8-weeks study period | 
| Incidence of adverse drug reactions |  | 8-weeks study period |