A Phase 3 Study to Assess the Efficacy and Safety of PK101 in Patients With Knee Osteoarthritis

Inclusion Criteria: * Patients ≥40 and of age * Patients who meets the American College Rheumatology (ACR) criteria and has lasted for at least three months after diagnosis of one-sided or bilateral knee osteoarthritis. * Radiographic evidence of grade 1 \~ 3 osteoarthritis based on the Kellgren \& Lawrence radiographic entry criteria at visit 1 * Score of 100mm pain VAS ≤ 80mm at visit 1 * Written consent form voluntarily * Score of 100mm pain VAS ≥ 40mm at visit 3 * Patients with an individual medication compliance of 70% or more of the IP administered during the Run-in period Exclusion Criteria: * Patients who has a history of hypersensitivity to components of IP, NSAIDs including COX-2 inhibitors, a history of hypersensitivity to aspirin, or allergic reactions to sulfonamides * Patients with inflammatory, infectious, metabolic, septic arthritis or rheumatoid arthritis other than osteoarthritis * Patients with a condition that can affect the joints * Patients who have undergone arthroscopic surgery within 1 year , knee joint surgery within 5 years, synoviorthesis within 3 months prior to visit 1 to the target knee, or who have planned surgery during the trial period * Patients who have used corticosteroids as follows: * Inj. of corticosteroid, including intraarticular administration, into the target knee within 3 months prior to visit 1 * Oral corticosteroid administration within 1 month prior to visit 1 * Patients who have intraarticular injected hyaluronic acid or cell therapy products, gene therapy products, etc. for the treatment of osteoarthritis within 3 months prior to visit 1