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This is a randomized, double-blind study to compare the efficacy and safety of LAYLA tablet and CENATONE tablet in the treatment of osteoarthritis of the knee.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LAYLA | Experimental | Drug : LAYLA tablet/bid |
|
| CENATONE | Active Comparator | Drug : CENATONE tablet/qd |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LAYLA tablet | Drug | 1 Tablet twice a day |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Changes from the baseline in 100mm Pain VAS | Baseline through week8 |
| Measure | Description | Time Frame |
|---|---|---|
| Changes rate from the baseline in 100mm Pain VAS | 8 weeks | |
| Changes from the baseline in WOMAC | 8 Weeks | |
| Changes from the baseline in EQ-5D |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Seung Baik Kang, MD | SMG-SNU Boramae Medical Center | Principal Investigator |
| Jeong Ku Ha, MD | Inje University | Principal Investigator |
| Han Jun Lee, MD | Chung-Ang University Hospital | Principal Investigator |
| Yong In, MD | The Catholic University of Korea | Principal Investigator |
| Jong Min Kim, MD | Asan Medical Center | Principal Investigator |
| Sahng Hoon Lee, MD | Seoul National University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Asan Medical Center | Seoul | South Korea | ||||
| Chung-Ang University Hospital |
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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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| ID | Term |
|---|---|
| D000077430 | Nabumetone |
| ID | Term |
|---|---|
| D002074 | Butanones |
| D007659 | Ketones |
| D009930 | Organic Chemicals |
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| CENATONE tablet | Drug | 2 Tablets once a day |
|
|
| 8 Weeks |
| Changes in the patient self-assessed overall symptom score | 8 Weeks |
| Seoul |
| South Korea |
| Inje University Seoul Paik Hospital | Seoul | South Korea |
| Seoul National University Hospital | Seoul | South Korea |
| SMG-SNU Boramae Medical Center | Seoul | South Korea |
| The Catholic University of Korea, Seoul ST. Mary's Hospital | Seoul | South Korea |
| D012216 |
| Rheumatic Diseases |