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

September 15, 2021 updated by: PMG Pharm Co., Ltd

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

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
354

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change during activity in 100mm Pain VAS
Time Frame: baseline through week 8
Visual Analogue Scale, 0 mm no pain, 100 mm worst pain ever
baseline through week 8

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change during activity in 100mm Pain VAS
Time Frame: baseline through week 4
Visual Analogue Scale, 0 mm no pain, 100 mm worst pain ever
baseline through week 4
Change at rest in 100mm Pain VAS
Time Frame: baseline through week 4, 8
Visual Analogue Scale, 0 mm no pain, 100 mm worst pain ever
baseline through week 4, 8
Change in WOMAC(Western Ontario and McMaster Universities Osteoarthritis Index using the Visual Analogue Scale, Version 3.1) sub scale & total score
Time Frame: 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.
baseline through week 4, 8
Change in PGA
Time Frame: baseline through week 8
PGA for disease severity (Patient's Global Assessment, 1=Very good, 2=Good, 3=Fair, 4=Poor, 5=Very Poor)
baseline through week 8
Change in SF-36 sub scale & PCS, MCS as measured by Health Survey(Short Form, SF-36 v2, Physical Component Summary, Mental Component Summary)
Time Frame: 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.
baseline through week 8

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
PMG Pharm Co., Ltd

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 20, 2021

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 15, 2022

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 15, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 5, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 21, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 26, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 22, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 15, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PK101_P301

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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