临床试验/NCT01390922

NCT01390922已完成不适用

Special Drug Use Investigation for Botox® (Botulinum) Spasticity

GlaxoSmithKline0 个研究点目标入组 1,038 人开始时间: 2011年8月最近更新: 2015年3月27日

适应症

干预措施

试验速览

阶段: 不适用
状态: 已完成
发起方: GlaxoSmithKline
入组人数: 1,038
主要终点: The number of adverse events in Japanese subjects with spasticity treated with botulinum injection

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者记录与标识符相似试验

研究概览

简要总结

The objective of this post-marketing surveillance study is to collect safety, efficacy and usage data on botulinum injection in subjects with upper or lower limb spasticity on the long-term use in clinical practice and to identify the factors affecting the safety or efficacy.

研究设计

研究类型: Observational
时间视角: Prospective

入排标准

性别: All
接受健康志愿者: 否

入选标准

•Subjects with upper or lower limb spasticity
•Subjects must use botulinum injection for the first time

排除标准

•Not applicable

研究组 & 干预措施

Subjects prescribed botulinum injection

干预措施: Botulinum Toxin Type A (Drug)

结局指标

主要结局

The number of adverse events in Japanese subjects with spasticity treated with botulinum injection

时间窗: 1 year

Occurence of adverse events associated with pulmonary function

时间窗: 1 year

Occurence of adverse events at remote sites

时间窗: 1 year

Onset status of adverse events associated with convulsion

时间窗: 1 year

Onset status of adverse events associated with accidents such as fall

时间窗: 1 year

次要结局

未报告次要终点

研究者

发起方

GlaxoSmithKline

申办方类型

Industry

责任方

Sponsor

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