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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DA-5202 High dose | Experimental | - DA-5202 20mg |
|
| DA-5202 Low dose | Experimental | - DA-5202 10mg |
|
| Na Hyaluronate 20mg | Active Comparator | Na Hyaluronate 20mg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DA-5202 20mg | Drug | once a week, intra-articular injection, for 3 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline of 100mm-VAS about weight bearing pain in study knee at week 3 | week 3 |
| 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 |
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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
presence of spur on radiological evidence
Kellgren-Lawrence Grade ā to ā ¢ 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:
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| Name | Affiliation | Role |
|---|---|---|
| Myung chul Lee, MD, PhD | Seoul National University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Hospital | Seoul | South Korea |
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| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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| DA-5202 10mg | Drug | once a week, intra-articular injection, for 3 weeks |
|
|
| Na Hyaluronate 20mg | Drug | once a week, intra-articular injection, for 3 weeks |
|
|
| 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 |
| D012216 |
| Rheumatic Diseases |