NCT00555061已完成4 期
An Open-Label, Non-Comparative Study to Assess the Pharmacokinetics, Safety and Efficacy of Topical Retapamulin (SB-275833) Ointment, 1%, Twice Daily for Five Days in the Treatment of Uncomplicated Skin and Skin Structure Infections in Pediatric Subjects Aged 2 to 24 Months
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Number of Participants With Measurable Plasma Concentrations, by Age Group
研究概览
简要总结
A study to evaluate the pharmacokinetics of Retapamulin Ointment, 1%, in pediatric subjects (2-24 months) with secondarily-infected traumatic lesions, secondarily-infected dermatoses, or impetigo (bullous and non-bullous).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 2 Months 至 24 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Arm 1
Experimental
Single Arm Retapamulin 1% Ointment
干预措施: Retapamulin Ointment, 1% (Drug)
结局指标
主要结局
Number of Participants With Measurable Plasma Concentrations, by Age Group
时间窗: Days 3 to 4; 4 to 8 hours post-dose of the first dose of the day
Pharmacokinetic (PK) samples were collected randomly in the window of 4 to 8 hours post-dose (except one at 3 hours and one at 11 hours post-dose) after the first daily dose of treatment on Day 3 or Day 4. The lower limit of quantification (LLQ) for retapamulin was 0.5 ng/mL.
次要结局
- Number of Participants With Clinical Success at Follow-up, by Type of Skin Infection and by Age(Follow-up, Days 12 to 16)
- Number of Participants by Age With Therapeutic Response of Success(Follow-up, Days 12 to 16)
- Bacteriological Success Rate at Follow-up, by Baseline Pathogen(Follow-up, Days 12 to 16)
研究者
研究点 (1)
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