Z-338 Phase III Trial - Evaluation of Pharmacokinetics, Efficacy and Safety in Paediatric Patients With Functional Dyspepsia
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 55
- 试验地点
- 1
- 主要终点
- AUC up to 8 hours after administration of single dose Z-338 before meal
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 9 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Placebo
干预措施: Placebo (Drug)
Z-338
干预措施: Acotiamide hydrochloride hydrate (Drug)
结局指标
主要结局
AUC up to 8 hours after administration of single dose Z-338 before meal
时间窗: The 1 day of single dose
Cmax of single dose Z-338 before meal
时间窗: The 1 day of single dose
Elimination rate of three symptoms (Postprandial fullness, Upper abdominal bloating and Early satiation)
时间窗: At week 4 of treatment or treatment discontinuation
Overall responder rate by the Overall Treatment Evaluation (OTE) scale
时间窗: At week 4 of treatment or treatment discontinuation
次要结局
- Incidence of adverse drug reactions(8-weeks study period)
- 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)