Knee OsteoarthritisPhase 3NCT04858659
A Phase 3 Study to Assess the Efficacy and Safety of PK101 in Patients With Knee Osteoarthritis
A Phase 3 study testing PK101 and PK101-002 in people with Knee Osteoarthritis, run by PMG Pharm Co., Ltd at 1 site in South Korea.
Trial summary
The purpose of this study is to compare the efficacy and the safety of PK101 in patients with knee osteoarthritis. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- PK101 and PK101-002
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 354 participants
- Where
- 1 siteSouth Korea
- Study dates
- 20 May 2021to 15 Mar 2022
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Jeonbuk National University Hospital
Jeonju, 54907
Wan-Hee Yoo, 82-63-250-2377, ywhim@chonbuk.ac.kr
About this study
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
The purpose of this study is to compare the efficacy and the safety of PK101 in patients with knee osteoarthritis.
Read the 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
- Being tested
- PK101, PK101-002, PK101 placebo, PK101-002 placebo
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PK101Drug
1 tablet at each time, 2 times a day
PK101-002Drug
1 tablet at each time, 2 times a day
PK101 placeboDrug
1 tablet at each time, 2 times a day
PK101-002 placeboDrug
1 tablet at each time, 2 times a day
| Study group | Role | What they receive |
|---|---|---|
| PK101 group | Experimental | Not described Receives: Drug: PK101; Drug: PK101-002 placebo |
| PK101-002 group | Active comparator | Not described Receives: Drug: PK101-002; Drug: PK101 placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change during activity in 100mm Pain VAS
Visual Analogue Scale, 0 mm no pain, 100 mm worst pain ever
Measured: baseline through week 8
Secondary outcomes (5)
Change during activity in 100mm Pain VAS
Visual Analogue Scale, 0 mm no pain, 100 mm worst pain ever
Measured: baseline through week 4
Change at rest in 100mm Pain VAS
Visual Analogue Scale, 0 mm no pain, 100 mm worst pain ever
Measured: 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
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.
Measured: baseline through week 4, 8
Change in PGA
PGA for disease severity (Patient's Global Assessment, 1=Very good, 2=Good, 3=Fair, 4=Poor, 5=Very Poor)
Measured: 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)
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.
Measured: baseline through week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2021
- Study start20 May 2021
- Primary completion15 Mar 2022 (estimated)
- Study completion15 Mar 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 354 participants (estimated)
Sponsor and investigators
- Lead sponsor
- PMG Pharm Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04858659
- Sponsor's protocol ID
- PK101_P301
- Status last verified
- Sep 2021
- First submitted
- 5 Apr 2021
- Last updated
- 22 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04858659
- Acronym / sponsor ID
- PK101_P301
- Conditions
- Knee Osteoarthritis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 354 participants (estimated)
- Lead sponsor
- PMG Pharm Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 20 May 2021 (actual)
- Primary completion
- 15 Mar 2022 (estimated)
- Study completion
- 15 Mar 2022 (estimated)
- First posted
- 26 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PK101 group | Experimental | Drug: PK101, Drug: PK101-002 placebo |
| PK101-002 group | Active comparator | Drug: PK101-002, Drug: PK101 placebo |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (8 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PK1011 tablet at each time, 2 times a day | Drug | PK101 group |
| PK101-0021 tablet at each time, 2 times a day | Drug | PK101-002 group |
| PK101 placebo1 tablet at each time, 2 times a day | Drug | PK101-002 group |
| PK101-002 placebo1 tablet at each time, 2 times a day | Drug | PK101 group |
Primary outcome
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
5 secondary outcomes
Change during activity in 100mm Pain VAS
Time frame: baseline through week 4
Change at rest in 100mm Pain VAS
Time frame: 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
Change in PGA
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing PK101 and PK101-002 in people with Knee Osteoarthritis, run by PMG Pharm Co., Ltd at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change during activity in 100mm Pain VAS (time frame: baseline through week 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2021.