Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to compare efficacy and safety of intra-articular LBSA0103 once versus intra-articular hyaluronic acid injections (Hyruan Plus Injection) once weekly for 3 weeks in the treatment of patients with osteoarthritis of the knee.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo and then LBSA0103 | Experimental | The experimental group receive once weekly for 2 weeks intraarticular injections of Placebo(saline). And then, they receive once intraarticular injections of LBSA0103 into the target knee. |
|
| Hyruan Plus | Active Comparator | The control group received once weekly for 3 weeks intraarticular injections of Hyruan Plus Inj. into the target knee. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | First 2 weeks Placebo(2ml) once weekly in experimental group |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Weight-bearing pain | using 100mm-VAS | 12 weeks after the last injection |
| Measure | Description | Time Frame |
|---|---|---|
| Weight-bearing pain | using 100mm-VAS | 1,6 weeks after the last injection |
| WOMAC-likert assessment | Pain, Function, Stiffness, Total score |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Hospital | Jongno-gu | Seoul | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28549436 | Derived | Ha CW, Park YB, Choi CH, Kyung HS, Lee JH, Yoo JD, Yoo JH, Choi CH, Kim CW, Kim HC, Oh KJ, Bin SI, Lee MC. Efficacy and safety of single injection of cross-linked sodium hyaluronate vs. three injections of high molecular weight sodium hyaluronate for osteoarthritis of the knee: a double-blind, randomized, multi-center, non-inferiority study. BMC Musculoskelet Disord. 2017 May 26;18(1):223. doi: 10.1186/s12891-017-1591-4. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Hyruan Plus |
| Drug |
Hyruan Plus Inj. (2ml)once weekly for 3 weeks in control group |
|
| LBSA0103 | Drug | at third week LBSA0103(60mg) once in experimental group |
|
| 1,6,12 weeks after the last injection |
| Patient Global Assessment | using 100mm-VAS | 1,6,12 weeks after the last injection |
| Investigator Global Assessment | using 100mm-VAS | 1,6,12 weeks after the last injection |
| D012216 |
| Rheumatic Diseases |