To Compare the Efficacy and Safety of LAYLA in Osteoarthritis Patients

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 Joins 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

Conditions
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Osteoarthritis of the Knee

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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients ≥40 and ≤ 80years of age Radiographic evidence of grade 2 or 3 osteoarthritis based on the Kellgren & Lawrene radiographic entry criteria Stable osteoarthritis during 3 months Score of 100mm pain VAS ≤ 80mm at screening Score of 100mm pain VAS ≥ 50mm at baseline Written consent form voluntarily Exclusion Criteria: Disease of spine or other Lower limb joints that could affect to 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 Medication of intra-articular injection within 3 months Diagnosed with psychical disorder, and taking medication History of upper gastrointestinal ulceration within 6 months History of upper gastrointestinal bleeding within 12 months Serum creatinine, ALT, AST, total bilirubin over UNL X 2.0 at screening test History of hypersensitivity to LAYLA, JOINS, 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 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: JOINS<br>Drug : JOINS tablet/ tid | Drug: JOINS tablet<br>* 1 tablet at each time, 3 times a day<br>* Other names: JOINS 200mg;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in 100mm Pain VAS |  | baseline throgh week 8 | 

Secondary Outcome Measures

| Outcome Measure | 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 |  | 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 | 

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