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

Study Overview
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Brief Summary
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The purpose of this study is to compare the efficacy and the safety of PK101 in patients with knee osteoarthritis.

Detailed Description
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The primary purpose of this study is to evaluate the efficacy of PK101 compared with PK101-002 at Week 8 in osteoarthritis. Also evaluates the safety of PK101.

Official Title
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A Multi-center, Randomized, Double-blind, Active-controlled, Parallel-designed, Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of PK101 Compared With PK101-002 in Patients With Knee Osteoarthritis

Conditions
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Knee Osteoarthritis

Intervention / Treatment
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* Drug: PK101
* Drug: PK101-002
* Drug: PK101 placebo
* Drug: PK101-002 placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PK101 group<br> | Drug: PK101<br>* 1 tablet at each time, 2 times a day<br>Drug: PK101-002 placebo<br>* 1 tablet at each time, 2 times a day<br>|
| Active Comparator: PK101-002 group<br> | Drug: PK101-002<br>* 1 tablet at each time, 2 times a day<br>Drug: PK101 placebo<br>* 1 tablet at each time, 2 times a day<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change during activity in 100mm Pain VAS | Visual Analogue Scale, 0 mm no pain, 100 mm worst pain ever | baseline through week 8 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change during activity in 100mm Pain VAS | Visual Analogue Scale, 0 mm no pain, 100 mm worst pain ever | baseline through week 4 | 
| Change at rest in 100mm Pain VAS | Visual Analogue Scale, 0 mm no pain, 100 mm worst pain ever | baseline through week 4, 8 | 
| Change in WOMAC(Western Ontario and McMaster Universities Osteoarthritis Index using the Visual Analogue Scale, Version 3.1) sub scale & total score | Assessment of pain, stiffness and physical function. Score range 0-500 mm for Pain, 0-200 mm for Stiffness, and 0-1700 mm for Physical Function. Higher scores indicate worse pain, stiffness, and functional limitations. | baseline through week 4, 8 | 
| Change in PGA | PGA for disease severity (Patient's Global Assessment, 1=Very good, 2=Good, 3=Fair, 4=Poor, 5=Very Poor) | baseline through week 8 | 
| Change in SF-36 sub scale & PCS, MCS as measured by Health Survey(Short Form, SF-36 v2, Physical Component Summary, Mental Component Summary) | The SF-36 v2 is a 36-item, patient-reported survey of patient's health, consisting of 2 components(the PCS and the MCS) included 8 subscales. Patients rated their QoL using a 2-6 point Likert Scale. Score is converting the original score to 0 100 points. The lower score means poor health status, and the higher score, the better. | baseline through week 8 |