NCT06021444已完成不适用
A Multi-center, Randomized, Double-blind, Active-controlled, Pivotal, Non-inferiority Clinical Study to Evaluate the Efficacy and Safety of 'DKM420' in Knee Osteoarthritis Patients.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- 100mm VAS(Visual Analogue Scale)
研究概览
简要总结
To prove the non-inferiority of DKM420 by evaluating the injecting efficacy and safety DKM 420 and control for patients who have osteoarthritis of Knee.
详细描述
A multi-center, randomized, double-blind, active-controlled, pivotal, non-inferiority clinical study
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 (Care Provider, Outcomes Assessor)
盲法说明
- Blind: Investigator
- Un-blind: Investigator(or CRC).
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and Women who is over 40 under 80 ages.
- •Diagnosed as osteoarthritis of Knee and satisfies the 3 of 6 ACR(American College of Rheumatology) conditions.
- •Kellgren Lawrence grade (Ⅰ~Ⅲ) at Visit 1 or within 24 weeks.
- •100mm VAS(Visual Analogue Scale) over 40mm.
排除标准
- •Pregnancy and lactating women
结局指标
主要结局
100mm VAS(Visual Analogue Scale)
时间窗: 16 weeks
Change(The minimum value is 0mm, the maximum value is 100m, the lower the better.)
次要结局
- 100mm VAS(Visual Analogue Scale)(2, 8 weeks)
- K-WOMAC(Korean Western Ontario and McMaster Universities)(2, 8, 16 weeks)
研究者
研究点 (1)
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