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

• Status: Completed
• Trial end date: 2016-10-14
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Dong-A ST Co., Ltd.

Criteria

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

1. knee joint pain

2. have any of the following

1. males and females more than 50 y

2. morning stiffness within 30 minutes

3. crepitus

3. 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