A Randomized, Double-blind, Sham-controlled, Initial Pilot Study to Evaluate the Safety and Temporary Symptom Improvement Efficacy of CKD-981 in Patients With Degenerative Knee Osteoarthritis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Change in weight-bearing knee pain measured using the Visual Analog Scale(VAS)
研究概览
简要总结
The purpose of this study is to prove that the temporary symptom improvement effect on knee osteoarthritis using CKD-981
详细描述
The aim of this pilot study is to evaluate the efficacy and safety of CKD-981 in patients with mild to moderate degenerative knee osteoarthritis who have been experiencing pain more than 8 weeks
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, Investigator)
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
- •Patients between 40 years and 80 years old
- •Patients who have experiencing knee pain more than 8 weeks
- •VAS more than 40 mm
- •Kellgren and Lawrence grade 2 and 3 in X' ray knee joint
排除标准
- •Previous knee surgery in affected side
- •Patients with Rheumatoid arthritis, connective tissue disease, Paget's disease
- •Infection of knee joint
- •BMI more than 35kg/m2
研究组 & 干预措施
Expermental group 1
Patients assigned to this group will receive treatment with the medical device CKD-981(1) in combination with a placebo.
干预措施: CKD-981(1) (Device)
Expermental group 1
Patients assigned to this group will receive treatment with the medical device CKD-981(1) in combination with a placebo.
干预措施: Placebo Drug (Drug)
Expermental group 2
Patients assigned to this group will receive treatment with the medical device CKD-981(2) in combination with a placebo.
干预措施: CKD-981(2) (Device)
Expermental group 2
Patients assigned to this group will receive treatment with the medical device CKD-981(2) in combination with a placebo.
干预措施: Placebo Drug (Drug)
Sham group
Patients assigned to this group will receive treatment with the sham device in combination with a placebo.
干预措施: Sham device (Device)
Sham group
Patients assigned to this group will receive treatment with the sham device in combination with a placebo.
干预措施: Placebo Drug (Drug)
Reference group
Patients assigned to this group will receive treatment with the sham device in combination with a reference drug.
干预措施: Sham device (Device)
Reference group
Patients assigned to this group will receive treatment with the sham device in combination with a reference drug.
干预措施: Reference Drug (Drug)
结局指标
主要结局
Change in weight-bearing knee pain measured using the Visual Analog Scale(VAS)
时间窗: 6 Weeks
Pain will be measured using a 10-cm Visual Analog Scale (VAS), with scores ranging from 0 (no pain) to 10 (worst imaginable pain)
次要结局
- Change in weight-bearing knee pain measured using the Visual Analog Scale(VAS)(2 weeks, 4 weeks)
- Change in total K-WOMAC (Korean Western Ontario and McMaster Universities Osteoarthritis Index) score from baseline(2 weeks, 4 weeks, 6 weeks)