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

Knee Osteoarthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04858659
• Other study ID #: PK101_P301
• Status: Recruiting
• Phase: Phase 3
• Start date: May 20, 2021
• Est. completion date: March 15, 2022

Study information

• Verified date: September 2021
• Source: PMG Pharm Co., Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 354
• Est. completion date: March 15, 2022
• Est. primary completion date: March 15, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Drug:
• PK101
1 tablet at each time, 2 times a day
• PK101-002
1 tablet at each time, 2 times a day
• PK101 placebo
1 tablet at each time, 2 times a day
• PK101-002 placebo
1 tablet at each time, 2 times a day

Locations

Country	Name	City	State
Korea, Republic of	Jeonbuk National University Hospital	Jeonju

Sponsors (1)

Lead Sponsor	Collaborator
PMG Pharm Co., Ltd

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change during activity in 100mm Pain VAS	Visual Analogue Scale, 0 mm no pain, 100 mm worst pain ever	baseline through week 8
Secondary	Change during activity in 100mm Pain VAS	Visual Analogue Scale, 0 mm no pain, 100 mm worst pain ever	baseline through week 4
Secondary	Change at rest in 100mm Pain VAS	Visual Analogue Scale, 0 mm no pain, 100 mm worst pain ever	baseline through week 4, 8
Secondary	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
Secondary	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
Secondary	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