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

Dong-A ST0 个研究点目标入组 120 人开始时间: 待定最近更新: 2019年3月11日

适应症

试验速览

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•male and female patients between 20 and 79 y old
•primary knee osteoarthritis confirmed clinically and radiologically according to American College of Rheumatology criteria and have following 3 items
•1.knee joint pain
•2.have any of the following
•a.males and females more than 50 y
•b.morning stiffness within 30 minutes
•3.presence of spur on radiological evidence
•Kellgren-Lawrence Grade ? to ? 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

•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(Non-Steroidal Anti-Inflammatory Drug)
•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
•any condition that, in the view of the investigator, would interfere with study participation

发起方

Dong-A ST