Z-338 Phase III trial - Evaluation of Pharmacokinetics, Efficacy and Safety in Paediatric patients with Functional Dyspepsia

Zeria Pharmaceutical Co., Ltd.0 个研究点目标入组 100 人开始时间: 2020年8月25日最近更新: 2023年10月17日

适应症

试验速览

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•Main Inclusion Criteria
•- 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 as the most bothersome symptom.
•- Subjects who have postprandial fullness, upper abdominal bloating or early satiation of a certain severity during one week prior to the day of randomization (Part 2 only).

•Main Exclusion Criteria
•- Subjects who have organic diseases of the gastrointestinal tract or gastrointestinal bleeding within 24 weeks prior to informed consent.
•- Subjects 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.
•- Subjects taking drugs used for functional dyspepsia within 2 weeks prior to the day of randomization (excluding proton pump inhibitors) (Part 2 only).
•- Subjects taking proton pump inhibitors within 4 weeks prior to the day of randomization (Part 2 only).

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