A Phase III Trial of Z-338 in Paediatric Patients With Functional Dyspepsia
Study Details
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.
Condition or Disease | Intervention/Treatment | Phase |
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Phase 3 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Experimental: Z-338
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Drug: Acotiamide hydrochloride hydrate
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
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Placebo Comparator: Placebo
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Drug: Placebo
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
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Outcome Measures
Primary Outcome Measures
- 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
- 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]
Eligibility Criteria
Criteria
Main Inclusion Criteria:
Part 1& Part 2
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Subjects aged from nine to 17 years (from nine to 14 years in Part 1), on the day the informed consent is signed.
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Subjects with a diagnosis of FD as defined by the Rome IV Criteria.
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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
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Subject who have organic diseases of the gastrointestinal tract or gastrointestinal bleeding within 24 weeks prior to informed consent.
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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.
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Subjects who have alarm symptom on the day the informed consent is signed.
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Subjects who have food allergy of unknown origin or uncontrolled food allergy.
Part 2 only
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Subject taking drugs used for FD within 2 weeks prior to the day of randomization (excluding proton pump inhibitors)
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Subject taking proton pump inhibitors within 4 weeks prior to the day of randomization.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Zeria Investigative Site | Matsumoto | Nagano | Japan |
Sponsors and Collaborators
- Zeria Pharmaceutical
Investigators
- Study Director: Tomoharu Miyagawa, Zeria Pharmaceutical
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- Z-338-07