NCT00908453已完成3 期
The Study of NPC-06 - Investigation of Safety, Efficacy and Pharmacokinetics of Fosphenytoin
Nobelpharma1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2009年5月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Incidence of adverse events
研究概览
简要总结
The study is to evaluate safety, efficacy and pharmacokinetics of intravenously administered fosphenytoin in patients with neurosurgery, head trauma, epilepsy or status epilepticus who are requiring a loading dose of phenytoin.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 2 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •male or female, hospitalized patients 2 years of age or older
- •Adult patients or guardian for pediatric patients to provide written informed consent
排除标准
- •patient with a history of hypersensitivity to hydantoins
- •patient with hypotension, sinus bradycardia, sino-atrial block, second or third degree A-V block, or Adams-Stokes syndrome
- •pregnant or nursing female patients
研究组 & 干预措施
15mg/kg of loading dose
Experimental
干预措施: fosphenytoin (Drug)
18mg/kg of loading dose
Experimental
干预措施: fosphenytoin (Drug)
22.5mg/kg of loading dose
Experimental
干预措施: fosphenytoin (Drug)
结局指标
主要结局
Incidence of adverse events
时间窗: 8 to 12 days
次要结局
- frequency and nature of seizures(8 to 12 days)
研究者
研究点 (1)
Loading locations...
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