EUCTR2010-024387-17-PL进行中（未招募）不适用
A Multi-center, Randomized, Open-Label, Parallel, Active-Comparator, Multiple Dose Trial to Determine the Efficacy, Safety, and Pharmacokinetics of Intravenous Ibuprofen in Pediatric Patients - Pediatric Fever Study: birth to = 16 years of age
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 200
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Parent or Legal Guardian able to provide written Informed Consent prior to participation in the study
- •2. Be between birth (28 weeks to < 40 weeks gestational age) to = 16 years
- •3. Inpatient status: currently inpatient or have admission scheduled and will soon become an inpatient
- •4. Febrile (temperature > 101.0°F
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 50
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Inadequate IV access
- •2. Have received antipyretic drug therapy within 2 hours before dosing
- •3. Have any history of allergy or hypersensitivity to NSAIDs, aspirin, or APAP
- •4. Have received another investigational drug within the past 30 days
- •5. Be otherwise unsuitable for the study, in the opinion of the Investigator
- •6. Fever due to Hyperthermia
- •7. Pregnant or nursing
研究者
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