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

NCT ID: NCT04858659

Last Updated: 2021-09-22

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 354 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-05-20
• Study Completion Date: 2022-03-15

Brief Summary

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

Detailed Description

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.

Conditions

Knee Osteoarthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

PK101 group

Group Type: EXPERIMENTAL

PK101

Intervention Type: DRUG

1 tablet at each time, 2 times a day

PK101-002 placebo

Intervention Type: DRUG

1 tablet at each time, 2 times a day

PK101-002 group

Group Type: ACTIVE_COMPARATOR

PK101-002

Intervention Type: DRUG

1 tablet at each time, 2 times a day

PK101 placebo

Intervention Type: DRUG

1 tablet at each time, 2 times a day

Interventions

PK101

1 tablet at each time, 2 times a day

Intervention Type: DRUG

PK101-002

1 tablet at each time, 2 times a day

Intervention Type: DRUG

PK101 placebo

1 tablet at each time, 2 times a day

Intervention Type: DRUG

PK101-002 placebo

1 tablet at each time, 2 times a day

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

PMG Pharm Co., Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Jeonbuk National University Hospital

Jeonju, , South Korea

Site Status: RECRUITING

Countries

South Korea

Facility Contacts

Wan-Hee Yoo

Role: primary

ywhim@chonbuk.ac.kr

82-63-250-2377

Other Identifiers

PK101_P301

Identifier Type: -

Identifier Source: org_study_id