NCT01002573已完成3 期
A Multicenter, Randomized, Open-Label, Parallel, Active-Comparator Trial to Determine the Efficacy, Safety, and Pharmacokinetics of Ibuprofen Injection in Pediatric Patients
Cumberland Pharmaceuticals17 个研究点 分布在 1 个国家目标入组 118 人开始时间: 2010年7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
- 118
- 试验地点
- 17
- 主要终点
- Fever Reduction
研究概览
简要总结
The primary objective of the study is to determine the superiority of a single dose of intravenous ibuprofen compared to acetaminophen for the treatment of fever during the first two hours of treatment.
详细描述
The primary objective of the study is to determine the superiority of a single dose of intravenous ibuprofen compared to acetaminophen for the treatment of fever as measured by the area under the change in temperature versus time curve during the first 2 hours of treatment.
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 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have written informed consent provided by legal parent, guardian, or authorized agent prior to participation in the study or study-only related procedures.
- •Be between birth (28 weeks to < 40 weeks gestational age) to ≤ 16 years of age.
- •Have new (less than 7 days) onset of fever, documented by temperature greater than or equal to 101.0 ºF (38.3 ºC).
排除标准
- •Have inadequate intravenous access.
- •Have received antipyretic drug therapy within 2 hours before dosing.
- •Have any history of allergy or hypersensitivity to NSAIDs or aspirin.
- •Have received another investigational drug within the past 30 days.
- •Be otherwise unsuitable for the study, in the opinion of the Investigator.
- •Have a fever due to hyperthermia.
- •Pregnant or nursing.
研究组 & 干预措施
ibuprofen
Experimental
Ibuprofen, 10 mg/kg
干预措施: ibuprofen (Drug)
Acetaminophen
Active Comparator
Acetaminophen, 10mg/kg
干预措施: acetaminophen (Drug)
结局指标
主要结局
Fever Reduction
时间窗: 0 to 2 hours post-dose
Treatment of fever as measured by the area under the change in temperature versus time curve during the first two hours of treatment (AUC0-2)
次要结局
- Change From Baseline in Temperature After the First Four Hours of Treatment(0 to 4 hours post-dose)
- Change From Baseline in Temperature After the First 30 Minutes of Treatment(30 minutes following treatment)
- Change From Baseline in Temperature After the First 60 Minutes of Treatment(60 minutes following treatment)
- Time to Afebrility (in Hours)(4 Hour post treatment)
- Change in Temperature(4 hours following treatment)
- Number of Afebrile and Febrile Subject at 4 Hours Post-Dose(4 Hours Post-Dose)
研究者
研究点 (17)
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