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

Sponsor

PMG Pharm Co., Ltd (Industry)

Overall Status

Recruiting

CT.gov ID

NCT04858659

Collaborator

(none)

354

Enrollment

Location

Arms

9.8

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Knee Osteoarthritis	Drug: PK101 Drug: PK101-002 Drug: PK101 placebo Drug: PK101-002 placebo	Phase 3

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

354 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

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

Actual Study Start Date :

May 20, 2021

Anticipated Primary Completion Date :

Mar 15, 2022

Anticipated Study Completion Date :

Mar 15, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: PK101 group	Drug: PK101 1 tablet at each time, 2 times a day Drug: PK101-002 placebo 1 tablet at each time, 2 times a day
Active Comparator: PK101-002 group	Drug: PK101-002 1 tablet at each time, 2 times a day Drug: PK101 placebo 1 tablet at each time, 2 times a day

Arm

Intervention/Treatment

Experimental: PK101 group

Drug: PK101

1 tablet at each time, 2 times a day

Drug: PK101-002 placebo

1 tablet at each time, 2 times a day

Active Comparator: PK101-002 group

Drug: PK101-002

1 tablet at each time, 2 times a day

Drug: PK101 placebo

1 tablet at each time, 2 times a day

Outcome Measures

Primary Outcome Measures

Change during activity in 100mm Pain VAS [baseline through week 8]
Visual Analogue Scale, 0 mm no pain, 100 mm worst pain ever

Secondary Outcome Measures

Change during activity in 100mm Pain VAS [baseline through week 4]
Visual Analogue Scale, 0 mm no pain, 100 mm worst pain ever
Change at rest in 100mm Pain VAS [baseline through week 4, 8]
Visual Analogue Scale, 0 mm no pain, 100 mm worst pain ever
Change in WOMAC(Western Ontario and McMaster Universities Osteoarthritis Index using the Visual Analogue Scale, Version 3.1) sub scale & total score [baseline through week 4, 8]
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.
Change in PGA [baseline through week 8]
PGA for disease severity (Patient's Global Assessment, 1=Very good, 2=Good, 3=Fair, 4=Poor, 5=Very Poor)
Change in SF-36 sub scale & PCS, MCS as measured by Health Survey(Short Form, SF-36 v2, Physical Component Summary, Mental Component Summary) [baseline through week 8]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Jeonbuk National University Hospital	Jeonju		Korea, Republic of	54907

Sponsors and Collaborators

PMG Pharm Co., Ltd

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

PMG Pharm Co., Ltd

ClinicalTrials.gov Identifier:

NCT04858659

Other Study ID Numbers:

PK101_P301

First Posted:

Apr 26, 2021

Last Update Posted:

Sep 22, 2021

Last Verified:

Sep 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Osteoarthritis

Osteoarthritis, Knee

Study Results

No Results Posted as of Sep 22, 2021