NCT00638534已完成3 期
Evaluation of the Safety, Efficacy, Pharmacokinetics, and Acceptability of HMR3647 20 mg/kg qd for 5 Days With Acute Otitis Media (AOM) in Children (Multicenter, Open Label, Non Comparative Study)
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- Safety evaluation: presence/absence of subjective/objective symptoms and abnormal laboratory findings
研究概览
简要总结
The primary objective is to assess the safety of telithromycin (HMR3647) 20 mg/kg qd for 5 days in children with acute otitis media (AOM).
Secondary objectives are to assess Efficacy, Pharmacokinetics and Acceptability of telithromycin 20 mg/kg qd for 5 days in children with AOM.
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
- 6 Months 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects who are weighing 40 kg or less. If female, premenarchal status is required.
- •Subjects with signs of infection according to middle ear signs and general signs or symptoms such as otalgia, fever, sleep disturbance, irritability, inconsolability.
- •The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
排除标准
- 未提供
结局指标
主要结局
Safety evaluation: presence/absence of subjective/objective symptoms and abnormal laboratory findings
次要结局
- Clinical efficacy: tympanic signs
- Acceptability: compliance and willingness to take medication
- Pharmacokinetics: plasma concentrations of telithromycin
研究者
研究点 (1)
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