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This is a randomized, double-blind study to compare the efficacy and safety of LAYLA tablet and Joins tablet in the treatment of osteoarthritis of the knee.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LAYLA | Experimental | Drug : LAYLA tablet/ bid |
|
| JOINS | Active Comparator | Drug : JOINS tablet/ tid |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LAYLA tablet | Drug | 1 tablet twice a day |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in 100mm Pain VAS | baseline throgh week 8 |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in 100mm pain VAS | 12 weeks | |
| Change rate from baseline in 100mm Pain VAS | 8 weeks, 12 weeks | |
| Change from baseline in WOMAC |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ye Soo Park | Hanyang University Guri Hospital | Principal Investigator |
| Chul Won Ha | Samsung Medical Center | Principal Investigator |
| Ye Yeon Won | Ajou University School of Medicine | Principal Investigator |
| Jae Hyup Lee | SMG-SNU Boramae Medical Center | Principal Investigator |
| Byung Woo Min | Keimyug University Dongsan Medical Center | Principal Investigator |
| Seung Beom Han | Korea University Anam Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Keimyug University Dongsan Medical Center | Daegu | South Korea | ||||
| Hanyang University Guri Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26821189 | Derived | Ha CW, Park YB, Min BW, Han SB, Lee JH, Won YY, Park YS. Prospective, randomized, double-blinded, double-dummy and multicenter phase IV clinical study comparing the efficacy and safety of PG201 (Layla) and SKI306X in patients with osteoarthritis. J Ethnopharmacol. 2016 Apr 2;181:1-7. doi: 10.1016/j.jep.2016.01.029. Epub 2016 Jan 25. |
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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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| JOINS tablet | Drug | 1 tablet at each time, 3 times a day |
|
|
| 8 weeks, 12 weeks |
| Change from baseline in EQ-5D | 8 weeks, 12 weeks |
| Change in the patient self-assessed & investigator-assessed overall symptom score | 8 weeks, 12 weeks |
| Consumption of rescue medication | 4 times |
| Seoul |
| South Korea |
| Korea University Anam Hospital | Seoul | South Korea |
| Samsung Medical Center | Seoul | South Korea |
| SMG-SNU Boramae Medical Center | Seoul | South Korea |
| Ajou University Hospital | Suwon | South Korea |
| D012216 |
| Rheumatic Diseases |