To Compare the Efficacy and Safety of LAYLA in Osteoarthritis Patients of the Knee

Study Overview
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Brief Summary
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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.

Official Title
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Double Blinded, Randomized, Active Drug Comparative, Multi-center, Phase Ⅳ Clinical Study to Compare the Efficacy and Safety of LAYLA in Osteoarthritis Patients of the Knee.

Conditions
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Osteoarthritis of the Knee

Intervention / Treatment
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* Drug: LAYLA tablet
* Drug: CENATONE tablet


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients ≥40 and ≤80 years of age Radiographic evidence of grade 1,2 or 3 osteoarthritis based on the Kellgren & Lawrence radiographic entry criteria Stable osteoarthritis during 3 months Score of 100mm Pain VAS ≤ 80mm at screening Score of 100mm Pain VAS ≥ 40mm at baseline Written consent form voluntarily Exclusion Criteria: Disease of spine or other Lower limb joints that could affect fo evaluate the efficacy History of surgery or arthroscopy of the study joint within 6 months Trauma of study joint within 12 months Medication of constantly(more than 1 week) corticosteroid by oral within 3 months Diagnosed with psychical disorder, and taking medication Medication of intra-articular injection within 3 months Uncontrollable Hypertension patients at screening test History of upper gastrointestinal ulceration within 6 months, History of upper gastrointestinal bleeding within 12 months History of lower gastrointestinal bleeding within 12 months History of coronary artery bypass, systemic lupus erythematosus or mixed connective tissue disease Serum creatinine, ALT, AST, total bilirubin over ULN X 2.0 at screening test History of hypersensitivity of LAYLA, CENATONE or NSAIDs Participation in another clinical trials within 4 weeks Medication of constantly (more than 1 week) narcotic analgesics within 3 months Not consent about using effectual contraception method during trial Pregnant or lactating woman History of malignant tumor within 5 years Investigator's judgment

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LAYLA<br>Drug : LAYLA tablet/bid | Drug: LAYLA tablet<br>* 1 Tablet twice a day<br>* Other names: LAYLA 405.4mg;|
| Active Comparator: CENATONE<br>Drug : CENATONE tablet/qd | Drug: CENATONE tablet<br>* 2 Tablets once a day<br>* Other names: Nabumetone 500mg;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes from the baseline in 100mm Pain VAS |  | Baseline through week8 | 

Secondary Outcome Measures

| Outcome Measure | 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 |  | 8 Weeks | 
| Changes in the patient self-assessed overall symptom score |  | 8 Weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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LAYLA, Non-inferiority, 100mm pain VAS