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

Primary Purpose

Knee Osteoarthritis

Status

Unknown status

Phase

Phase 3

Locations

Korea, Republic of

Study Type

Interventional

Intervention

PK101

PK101-002

PK101 placebo

PK101-002 placebo

About this trial

This is an interventional treatment trial for Knee Osteoarthritis

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Jeonbuk National University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

PK101 group

PK101-002 group

Arm Description

Outcomes

Primary Outcome Measures

Change during activity in 100mm Pain VAS

Visual Analogue Scale, 0 mm no pain, 100 mm worst pain ever

Secondary Outcome Measures

Change during activity in 100mm Pain VAS

Visual Analogue Scale, 0 mm no pain, 100 mm worst pain ever

Change at rest in 100mm Pain VAS

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

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

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)

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.

Full Information

NCT ID

NCT04858659

First Posted

April 5, 2021

Last Updated

September 15, 2021

Sponsor

PMG Pharm Co., Ltd

1. Study Identification

Unique Protocol Identification Number

NCT04858659

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2021

Overall Recruitment Status

Unknown status

Study Start Date

May 20, 2021 (Actual)

Primary Completion Date

March 15, 2022 (Anticipated)

Study Completion Date

March 15, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

PMG Pharm Co., Ltd

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Knee Osteoarthritis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

354 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

PK101 group

Arm Type

Experimental

Arm Title

PK101-002 group

Arm Type

Active Comparator

Intervention Type

Drug

Intervention Name(s)

PK101

Intervention Description

1 tablet at each time, 2 times a day

Intervention Type

Drug

Intervention Name(s)

PK101-002

Intervention Description

1 tablet at each time, 2 times a day

Intervention Type

Drug

Intervention Name(s)

PK101 placebo

Intervention Description

1 tablet at each time, 2 times a day

Intervention Type

Drug

Intervention Name(s)

PK101-002 placebo

Intervention Description

1 tablet at each time, 2 times a day

Primary Outcome Measure Information:

Title

Change during activity in 100mm Pain VAS

Description

Visual Analogue Scale, 0 mm no pain, 100 mm worst pain ever

Time Frame

baseline through week 8

Secondary Outcome Measure Information:

Title

Change during activity in 100mm Pain VAS

Description

Visual Analogue Scale, 0 mm no pain, 100 mm worst pain ever

Time Frame

baseline through week 4

Title

Change at rest in 100mm Pain VAS

Description

Visual Analogue Scale, 0 mm no pain, 100 mm worst pain ever

Time Frame

baseline through week 4, 8

Title

Change in WOMAC(Western Ontario and McMaster Universities Osteoarthritis Index using the Visual Analogue Scale, Version 3.1) sub scale & total score

Description

Time Frame

baseline through week 4, 8

Title

Change in PGA

Description

PGA for disease severity (Patient's Global Assessment, 1=Very good, 2=Good, 3=Fair, 4=Poor, 5=Very Poor)

Time Frame

baseline through week 8

Title

Change in SF-36 sub scale & PCS, MCS as measured by Health Survey(Short Form, SF-36 v2, Physical Component Summary, Mental Component Summary)

Description

Time Frame

baseline through week 8

10. Eligibility

Sex

All

Minimum Age & Unit of Time

40 Years

Accepts Healthy Volunteers

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

Facility Information:

Facility Name

Jeonbuk National University Hospital

City

Jeonju

ZIP/Postal Code

54907

Country

Korea, Republic of

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Wan-Hee Yoo

Phone

82-63-250-2377

ywhim@chonbuk.ac.kr

12. IPD Sharing Statement

Learn more about this trial

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

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