Overview

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

Status:
Recruiting
Trial end date:
2022-03-15
Target enrollment:
0
Participant gender:
All
Summary
The purpose of this study is to compare the efficacy and the safety of PK101 in patients with knee osteoarthritis.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
PMG Pharm Co., Ltd
Criteria
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