Osteoarthritis, Knee
Conditions
Brief summary
This Phase II clinical study is to evaluate the efficacy and safety of DA-5202 in patients with osteoarthritis of the knee.
Detailed description
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.
Interventions
DRUGDA-5202 20mg
once a week, intra-articular injection, for 3 weeks
DRUGDA-5202 10mg
once a week, intra-articular injection, for 3 weeks
DRUGNa Hyaluronate 20mg
once a week, intra-articular injection, for 3 weeks
Sponsors
Dong-A ST Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline of 100mm-VAS about weight bearing pain in study knee at week 3 | week 3 |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| 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 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 |
| overall assessment of subject and investigator (5-Likert scale) | week 1,2,3,7,12 |
Countries
South Korea
Outcome results
None listed