Clinical trial: To Compare the Efficacy and Safety of LAYLA in Osteoarthritis Patients of the Knee (NCT02049606)

Eligibility criteria:
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
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 40 Years old.
Subject must be at most 80 Years

Patient description (medical language): A 47-year-old woman comes to the office complaining of pain in the calf and knee when she bends down. The pain limits her activity. Her medical history is significant for osteoarthritis, for which she uses nonsteroidal anti-inflammatory drugs (NSAIDs) for the past two years. She is living with her husband and has 3 children. She doesn't smoke but drinks alcohol occasionally. Her vital signs are normal. On physical examination, there is a small effusion in the right knee. The effusion grew a little larger and she developed a tender swelling in the popliteal fossa and calf. Both the pain and swelling worsened as she bent and straightened her knee.

Patient description (patient's own words): I'm a 47-year-old woman, married with 3 kids. I don't smoke and I drink occasionally. I went to the doctor because of pain in my calf and knee when I was bending down. This has been limiting my daily activities. I have been diagnosed with osteoarthritis for which I have taken anti-inflammatory drugs for the past 2 years. The doctor saw a small fluid buildup in my right knee. This buildup became a bit bigger and I have a swollen calf. The pain is worse when I bend and straighten my knee.

Does the patient match the trial criteria? Entailment