NCT02554240已完成2 期
Active-controlled, Dose-Response, Randomized, Double-blind, Therapeutic Exploratory Clinical Trial to Evaluate the Efficacy and Safety of Intra-articular DA-5202 in Patients With Osteoarthritis of the Knee
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 115
- 试验地点
- 1
- 主要终点
- Change from baseline of 100mm-VAS about weight bearing pain in study knee at week 3
研究概览
简要总结
This Phase II clinical study is to evaluate the efficacy and safety of DA-5202 in patients with osteoarthritis of the knee.
详细描述
Eligible subjects are randomly assigned to receive DA-5202 high dose(20mg) or DA-5202 low dose(10mg) or Na Hyaluronate once a week intra-articular injection for 3 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
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •male and female patients between 20 and 80 y old
- •primary knee osteoarthritis confirmed clinically and radiologically according to American College of Rheumatology criteria and have following 3 items
- •knee joint pain
- •have any of the following
- •males and females more than 50 y
- •morning stiffness within 30 minutes
- •presence of spur on radiological evidence
- •Kellgren-Lawrence Grade Ⅰ to Ⅲ confirmed radiologically
- •knee pain under weight-bearing greater than 40/100mm-VAS(Visual Analogue Scale) at randomization visit
- •patients willing and able to provide signed informed consent after the nature of the study has been explained
排除标准
- •BMI(Body Mass Index) > 32
- •complete obliteration of femoropatellar joint space on X-ray
- •Kellgren-Lawrence Grade IV
- •knee surgery within a year
- •history of fracture, rheumatoid arthritis or other inflammatory arthritis in knee articular cavity
- •intra-articular corticosteroid injection within 3 months or hyaluronate injection within 6 months
- •skin diseases or infection overlying the joint
- •history of severe drug allergy or hypersensitivity to drugs(piroxicam, hyaluronic acid)
- •history of allergy, asthma, rhinitis, angioedema, rash to aspirin or other NSAIDs (including COX-2 inhibitor)
- •treatment with anticoagulants such as heparin or coumarins (warfarin etc.)
- •History of GI diseases such as peptic ulcer, bleeding, perforation, ulcerative colitis, Crohn's disease within 1 year
- •severe hypertension
- •patients with psychiatric disorder, alcoholism, drug addiction
- •presence of severe concomitant diseases or malignancy within 5 years
- •have participated in another clinical trial 4 weeks prior to the study
- •women of child-bearing potential who are not using *adequate means of contraception (*adequate means of contraception: condom, oral contraception, barrier methods using spermicide, intrauterine devices etc.)
- •any condition that, in the view of the investigator, would interfere with study participation
研究组 & 干预措施
DA-5202 High dose
Experimental
- DA-5202 20mg
干预措施: DA-5202 20mg (Drug)
DA-5202 Low dose
Experimental
- DA-5202 10mg
干预措施: DA-5202 10mg (Drug)
Na Hyaluronate 20mg
Active Comparator
Na Hyaluronate 20mg
干预措施: Na Hyaluronate 20mg (Drug)
结局指标
主要结局
Change from baseline of 100mm-VAS about weight bearing pain in study knee at week 3
时间窗: week 3
次要结局
- Change from baseline of 100mm-VAS about Weight bearing pain in study knee at week 1,2,7,12(week 1,2,7,12)
- knee joint effusion change (Observation by investigator)(24 weeks)
- knee joint range of motion change (Observation by investigator)(24 weeks)
- Change from baseline of 100mm-VAS about Resting pain in study knee at week 1,2,3,7,12(week 1,2,3,7,12)
- overall assessment of subject and investigator (5-Likert scale)(week 1,2,3,7,12)
- Change from baseline of 100mm-VAS about Motion pain in study knee at week 1,2,3,7,12(week 1,2,3,7,12)
- Change from baseline of 100mm-VAS about Night pain in study knee at week 1,2,3,7,12(week 1,2,3,7,12)
- Change from baseline of WOMAC Index total score at Week 1,2,3,7,12(week 1,2,3,7,12)
研究者
研究点 (1)
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