NCT02893098已完成3 期
A Study to Evaluate the Safety and Efficacy of Humia Inj. in Patients With Symptomatic Osteoarthritis of the Knee
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 232
- 试验地点
- 1
- 主要终点
- Change from baseline of Weight-bearing pain (100mm-VAS)
研究概览
简要总结
A Multi-Centre, Parallel, Double-Blind, Active comparator, Randomised phase III Clinical Trial
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Primary knee osteoarthritis confirmed clinically and radiologically according to American College of Rheumatology criteria have joint pain
- •Kellgren-Lawrence Grade Ⅰ to Ⅲ confirmed radiologically within 6 months
- •Knee pain under weight-bearing pain(100mm-VAS) greater than 40mm
- •Able to walk without assistive devices
- •Patients willing and able to provide signed informed consent after the nature of the study has been explained
- •Exclusion criteria:
- •Body Mass Index (BMI) > 32
- •History of rheumatoid arthritis or other inflammatory arthritis in knee articular cavity
- •Systemic Intravenous Steroid injection within 1 month, intra-articular corticosteroid injection within 3 months or hyaluronate injection within 6 months
- •Has clinically severe tense effusion of the target knee diagnosed Positive according to Patella tap test
- •Undergo Knee Replacement Surgery of the target knee
排除标准
- 未提供
研究组 & 干预措施
Humia inj.
Experimental
Participants with symptomatic Primary Osteoarthritis of Knee received a single injection of 3ml Humia inj.
干预措施: Humia inj. (Drug)
High Hyal Plus inj.
Active Comparator
Participants (Control Group) with symptomatic Primary Osteoarthritis of Knee received single injection of 2ml High Hyal Plus inj. given weekly for 3 weeks
干预措施: High hyal Plus inj. (Drug)
结局指标
主要结局
Change from baseline of Weight-bearing pain (100mm-VAS)
时间窗: Week 14
次要结局
- Change from baseline of Weight-bearing pain (100mm-VAS)(Weeks 3, 8, 14, and 26)
- Physical Examination : Swelling(Weeks 0, 3, 8, 14, 26, and 38)
- Physical Examination : Tenderness on pressure(Weeks 0,3,8,14,26,and 38)
- Physical Examination : Range of motion(Weeks 0, 3, 8, 14, 26, and 38)
- Consumption of rescue medication(Weeks 0, 1, 2, 3, 8, 14, 26, and 38)
- Proportion (%) of patients taking rescue medication(Weeks 0, 1, 2, 3, 8, 14, 26, and 38)
- Change from Visit 8 of Weight-bearing pain (100mm-VAS)(Week 38)
- Responder Rate(Week 14)
研究者
研究点 (1)
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