NCT01445600已完成不适用
An Open Label, Multi-centre, Non-interventional Post-marketing Surveillance (PMS) to Monitor the Safety and Efficacy of ALTARGO(Retapamulin) Administered in Korean Patients According to the Prescribing Information
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 3,612
- 试验地点
- 1
- 主要终点
- The number of adverse event after ALTARGO(retapamulin) treatment
研究概览
简要总结
This is an open label, multi-centre, non-interventional post-marketing surveillance.
详细描述
This is an open label, multi-centre, non-interventional post-marketing surveillance to monitor the safety of ALTARGO(retapamulin) treated in Korean patients according to the prescribing information.
ALTARGO is a trademark of the GlaxoSmithKline group of companies.
研究设计
- 研究类型
- Observational
- 时间视角
- Prospective
入排标准
- 年龄范围
- 9 Months 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All subjects must satisfy the following criteria at study entry:
- •Subjects administered with ALTARGO(retapamulin) in the topical treatment of the following bacterial skin and skin structure infections (SSSI)
- •Subjects who the investigator believes that they can and will comply with the requirements of the protocol and follow the administration regimen
- •Subjects administered with ALTARGO(retapamulin) following the locally approved prescribing information
排除标准
- •Considering the nature of observational study, GSK Korea encourages the doctors participating in this study to enrol the subjects prescribed with retapamulin following the locally approved Prescribing Information.
- •Subjects with a known or suspected hypersensitivity to ALTARGO(retapamulin) or any component of the ointment
- •Infants under nine months of age
研究组 & 干预措施
ALTARGO(retapamulin)
The subjects with bacterial skin and skin structure infections (SSSI)
干预措施: ALTARGO(retapamulin) (Drug)
结局指标
主要结局
The number of adverse event after ALTARGO(retapamulin) treatment
时间窗: 14 days
次要结局
- The number of serious adverse event after ALTARGO(retapamulin) treatment(14 days)
- The number of unexpected adverse event after ALTARGO(retapamulin) treatment(14 days)
- Effectiveness of ALTARGO(retapamulin) treatment(7 days)
研究者
研究点 (1)
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