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 forat least three months after diagnosis of one-sided or bilateral knee osteoarthritis.
• Radiographic evidence of grade 1 ~ 3 osteoarthritis based on the Kellgren & Lawrenceradiographic 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 IPadministered during the Run-in period

Exclusion Criteria:

• Patients who has a history of hypersensitivity to components of IP, NSAIDs includingCOX-2 inhibitors, a history of hypersensitivity to aspirin, or allergic reactions tosulfonamides
• Patients with inflammatory, infectious, metabolic, septic arthritis or rheumatoidarthritis other than osteoarthritis
• Patients with a condition that can affect the joints
• Patients who have undergone arthroscopic surgery within 1 year , knee joint surgerywithin 5 years, synoviorthesis within 3 months prior to visit 1 to the target knee, orwho have planned surgery during the trial period
• Patients who have used corticosteroids as follows:
• Inj. of corticosteroid, including intraarticular administration, into the targetknee 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 priorto visit 1