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临床试验/NCT04369261
NCT04369261已完成不适用

A Multicenter, Prospective Observational Study to Evaluate the Injection Site Reactions of Synovian® Inj. in Patients With Osteoarthritis in the Knee

LG Chem1 个研究点 分布在 1 个国家目标入组 1,949 人开始时间: 2018年3月9日最近更新:
适应症
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
1,949
试验地点
1
主要终点
safety endpoints

研究概览

简要总结

This is an observational study to evaluate the injection site reactions of Synovian® Inj. in patients with osteoarthritis in the knee

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

年龄范围
19 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adult male or female patient of over 19 years of age
  • A patient diagnosed with knee osteoarthritis
  • A patient who has been informed of the purpose, method of the study and signed the written informed consent form.

排除标准

  • A patient who shows hypersensitive reaction to the Synovian® Inj. or to the ingredients of Synovian® Inj.
  • A patient with infection at the joint
  • A patient with skin infection or skin disease at the injection area
  • A patient diagnosed with osteoarthritis with the Kellgren & Lawrence Grade IV in X-ray within 12 months before enrollment of this study.

结局指标

主要结局

safety endpoints

时间窗: Week 2

injection site reactions

次要结局

未报告次要终点

研究者

发起方
LG Chem
申办方类型
Industry
责任方
Sponsor

研究点 (1)

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