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A Multi-Centre, Parallel, Double-Blind, Active comparator, Randomised phase III Clinical Trial
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Humia inj. | Experimental | Participants with symptomatic Primary Osteoarthritis of Knee received a single injection of 3ml Humia inj. |
|
| High Hyal Plus inj. | Active Comparator | Participants (Control Group) with symptomatic Primary Osteoarthritis of Knee received single injection of 2ml High Hyal Plus inj. given weekly for 3 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Humia inj. | Drug | Single injection of 3mL Humia inj. Dummy: Single injection 2ml Normal Saline inj. given weekly for 2 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline of Weight-bearing pain (100mm-VAS) | Week 14 |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline of Weight-bearing pain (100mm-VAS) | Weeks 3, 8, 14, and 26 | |
| Change from Visit 8 of Weight-bearing pain (100mm-VAS) | Week 38 | |
| Physical Examination : Swelling |
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Inclusion Criteria:
Exclusion criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Huons | Ansan-si | Gyeonggi-do | 15588 | 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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| High hyal Plus inj. | Drug | Single Injection of 2mL High hyal Plus inj. given weekly for 3 weeks |
|
| Weeks 0, 3, 8, 14, 26, and 38 |
| Physical Examination : Tenderness on pressure | Weeks 0,3,8,14,26,and 38 |
| Physical Examination : Range of motion | Weeks 0, 3, 8, 14, 26, and 38 |
| Consumption of rescue medication | Weeks 0, 1, 2, 3, 8, 14, 26, and 38 |
| Proportion (%) of patients taking rescue medication | Weeks 0, 1, 2, 3, 8, 14, 26, and 38 |
| Responder Rate | Week 14 |
| D012216 |
| Rheumatic Diseases |