NCT05930080已完成3 期
Multi-center, Randomized, Double Blinded, Active-controlled Phase III Clinical Trial to Assess the Efficacy and Safety of SKCPT in Patients With Knee Osteoarthritis
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
- 278
- 试验地点
- 1
- 主要终点
- K-WOMAC Pain Subscale
研究概览
简要总结
Multi-center, Randomized, Double Blinded, Active-controlled Phase III Clinical Trial to Assess the Efficacy and Safety of SKCPT in Patients with knee Osteoarthritis
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult males and females aged 20 to 75 years
- •Kellgren-Lawrence (KL) grade 1 to 3
- •Individuals who voluntarily decide to participate in the study and provide written informed consent form
- •Individuals who can understand and follow instructions and can participate in the study during the entire study period
排除标准
- •Individuals who have clear secondary osteoarthritis caused by inflammatory, infectious, metabolic arthritis, or other conditions such as rheumatoid arthritis, rather than primary knee osteoarthritis as determined by the investigator
- •Individuals with other factors that could potentially affect the assessment of this clinical study due to pain caused by osteoarthritis or other conditions in the hip joint
- •Individuals who have undergone knee joint arthroplasty
- •Individuals who have undergone open knee surgery (ligament reconstruction, osteotomy) within 3 years prior to the screening visit
研究组 & 干预措施
SKCPT group
Experimental
干预措施: SKCPT (Drug)
Celebrex group
Active Comparator
干预措施: Celebrex (Drug)
结局指标
主要结局
K-WOMAC Pain Subscale
时间窗: 84 days
The average changes in the K-WOMAC(Western Ontario and McMasters Universitis) Pain Subscale (range: 0-100 mm, higher scores mean a worse outcome)
次要结局
未报告次要终点
研究者
研究点 (1)
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