NCT00474019已完成1 期
A Phase I, Randomised, Open-label, Multi-National Study to Evaluate the Pharmacokinetics of Repeated Once-Daily Intravenous Doses of Esomeprazole in Paediatric Patients 0 to 17 Years Old, Inclusive.
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Pharmacokinetic-area under plasma concentration versus time curve within a dosing interval
研究概览
简要总结
The purpose of this research study is to evaluate how much of repeated once daily intravenous (IV, meaning through a vein) doses of esomeprazole gets into the bloodstream of hospitalized children aged 0-17 years old that require acid suppression therapy.
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
- None
入排标准
- 年龄范围
- — 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •parent/guardian must sign consent form and the child will be asked to sign and Assent Form if he/she is old enough and is able to sign
- •verbal assent will be acceptable if the child is old enough to understand, but unable to write
- •female and/or male hospitalized patients aged 0-17 years old who should be considered for treatment with acid suppressive therapy.
排除标准
- •female patients that are pregnant, or plan to become pregnant during the study period or is breast-feeding a child
- •patients with a history of multiple drug allergies
- •any illness, medical history, abnormal laboratory values, abnormal physical examination findings or abnormal vitals signs that could put the patient at risk when participating in the study
研究组 & 干预措施
1
Experimental
Based on age and/or weight dose of esomeprazole IV qd in milligrams 20,40,10,20,10, 1.0 mg/kg, 0,5 mg/kg
干预措施: esomeprazole (Drug)
结局指标
主要结局
Pharmacokinetic-area under plasma concentration versus time curve within a dosing interval
时间窗: Day 4 of study
次要结局
- Maximum plasma concentration, total, plasma clearance, steady-state volume of distribution of esomeprazole(Day 4 of study)
- Safety and tolerability will be assessed by AEs, laboratory values, blood pressure, heart rate, respiratory rate, body temperature, and ECG(Days 1-4 (during treatment), Days 1-28 (post treatment))
- Evaluate main metabolites of esomeprazole (sulphone metabolite and 5-hydroxy metabolite) by assessment of max plasma conc, total area under the plasma concentration vs time curve within a dosing interval, clearance scaled by fraction metabolised(Day 4)
研究者
研究点 (1)
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