Back to resultsA Phase III Trial of Z-338 in Paediatric Patients With Functional Dyspepsia
Primary Purpose
Functional Dyspepsia
Status
Recruiting
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
Acotiamide hydrochloride hydrate
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Functional Dyspepsia
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.
Sites / Locations
- Zeria Investigative SiteRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Z-338
Placebo
Arm Description
Outcomes
Primary Outcome Measures
Cmax of single dose Z-338 before meal
AUC up to 8 hours after administration of single dose Z-338 before meal
Elimination rate of three symptoms (Postprandial fullness, Upper abdominal bloating and Early satiation)
Overall responder rate by the Overall Treatment Evaluation (OTE) scale
Secondary Outcome Measures
Elimination rate of each symptom
Average severity score of each symptom
Worst severity score of each symptom
Weekly responder rate by the OTE scale
Incidence of adverse events
Incidence of adverse drug reactions
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04526119
Brief Title
A Phase III Trial of Z-338 in Paediatric Patients With Functional Dyspepsia
Official Title
Z-338 Phase III Trial - Evaluation of Pharmacokinetics, Efficacy and Safety in Paediatric Patients With Functional Dyspepsia
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 22, 2021 (Actual)
Primary Completion Date
February 2025 (Anticipated)
Study Completion Date
April 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Zeria Pharmaceutical
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Functional Dyspepsia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Z-338
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Acotiamide hydrochloride hydrate
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
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
Primary Outcome Measure Information:
Title
Cmax of single dose Z-338 before meal
Time Frame
The 1 day of single dose
Title
AUC up to 8 hours after administration of single dose Z-338 before meal
Time Frame
The 1 day of single dose
Title
Elimination rate of three symptoms (Postprandial fullness, Upper abdominal bloating and Early satiation)
Time Frame
At week 4 of treatment or treatment discontinuation
Title
Overall responder rate by the Overall Treatment Evaluation (OTE) scale
Time Frame
At week 4 of treatment or treatment discontinuation
Secondary Outcome Measure Information:
Title
Elimination rate of each symptom
Time Frame
Weekly from the day of randomization to Week 8
Title
Average severity score of each symptom
Time Frame
Weekly from the day of randomization to Week 8
Title
Worst severity score of each symptom
Time Frame
Weekly from the day of randomization to Week 8
Title
Weekly responder rate by the OTE scale
Time Frame
Weekly from the day of randomization to Week 8
Title
Incidence of adverse events
Time Frame
8-weeks study period
Title
Incidence of adverse drug reactions
Time Frame
8-weeks study period
10. Eligibility
Sex
All
Minimum Age & Unit of Time
9 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zeria R&D
Phone
+81-35644-7053
Email
kikaku@zeria.co.jp
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tomoharu Miyagawa
Organizational Affiliation
Zeria Pharmaceutical
Official's Role
Study Director
Facility Information:
Facility Name
Zeria Investigative Site
City
Matsumoto
State/Province
Nagano
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zeria Investigative PI
Phone
+81-35644-7053
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Phase III Trial of Z-338 in Paediatric Patients With Functional Dyspepsia
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