Study to Evaluate the Efficacy and Safety of Intra-articular DA-5202 in Patients With Osteoarthritis of the Knee

Study Overview
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Brief Summary
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This Phase II clinical study is to evaluate the efficacy and safety of DA-5202 in patients with osteoarthritis of the knee.

Detailed Description
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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.

Official Title
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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

Conditions
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Osteoarthritis, Knee

Intervention / Treatment
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* Drug: DA-5202 20mg
* Drug: DA-5202 10mg
* Drug: Na Hyaluronate 20mg


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 crepitus 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DA-5202 High dose<br>- DA-5202 20mg | Drug: DA-5202 20mg<br>* once a week, intra-articular injection, for 3 weeks<br>* Other names: DA-5202 high dose;|
| Experimental: DA-5202 Low dose<br>- DA-5202 10mg | Drug: DA-5202 10mg<br>* once a week, intra-articular injection, for 3 weeks<br>* Other names: DA-5202 low dose;|
| Active Comparator: Na Hyaluronate 20mg<br>Na Hyaluronate 20mg | Drug: Na Hyaluronate 20mg<br>* once a week, intra-articular injection, for 3 weeks<br>* Other names: Hyruan Plus®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline of 100mm-VAS about weight bearing pain in study knee at week 3 |  | week 3 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline of 100mm-VAS about Weight bearing pain in study knee at week 1,2,7,12 |  | week 1,2,7,12 | 
| 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 | 
| knee joint range of motion change (Observation by investigator) |  | 24 weeks | 
| knee joint effusion change (Observation by investigator) |  | 24 weeks | 
| 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 |