Osteoarthritis of the KneePhase 3NCT01576419
Active Drug Comparative, Multi-center, phase3 Clinical Study to Evaluate the Efficacy and Safety of PG201 in Osteoarthritis Patients
A Phase 3 study testing PG201 tablet and Celebrex capsule in people with Osteoarthritis of the Knee, run by PMG Pharm Co., Ltd at 1 site in South Korea.
Trial summary
The objective of this study was to to evaluate the efficacy and safety of PG201 in osteoarthritis patients. This clinical study was designated to be non-inferiority test with level of significance: 95%, α=0.05. Type 2 error (β) was set as 0.2, and the power of the test was set as 80%. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Osteoarthritis of the Knee
- What is being tested?
- PG201 tablet and Celebrex capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 309 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jan 2010to Sep 2011
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients ≥40 and ≤ 80years of age.
- Patients who meet the American College of Rheumatology clinical plus radiographic classification criteria for idiopathic osteoarthritis of the knee, which are defined as follow:
- a patient who had knee pain and radiographically diagnosed osteophytes and met at least one of the followings.
- Age> 50 years.
- Morning stiffness for less than 30 minutes.
- Crepitus during movement of the weight-bearing knee.
Show all 11Show fewer
- Patients with symptomatic primary osteoarthritis of the knee at least in the last 3 months prior to screening.
- Patients who received Nonsteroidal antiinflammatory drugs (NSAIDs)/Cyclooxygenase-2 inhibitor for the treatment of arthritis of the knee for at least 5 days a week during 4 weeks prior to screening.
- Patients who had a score of 100mm pain VAS ≤80 mm at screening.
- Patients who had a score of 100mm pain VAS ≥50 mm at baseline.
- Patients should be able and willing to provide the written informed consent.
Who cannot join
- Patients with a history of surgery or arthroscopy of the study joint within the previous 6 months.
- Patients with trauma of study joint within the previous 12 months.
- Patients with symptomatic hip osteoarthritis, other condition that would interfere with study assessments.
- Patients with any other type of arthritis, active malignancies or any active GI, cardiovascular, renal, hepatic, neurologic, or psychiatric disease.
- Patients with a known hypersensitivity or intolerance to Nonsteroidal antiinflammatory drugs (NSAIDs), aspirin or Cyclooxygenase-2 inhibitor.
- Patients with uncontrollable hypertension.
- Patients with any of creatinine, bilirubin, Alanine aminotransferase or Aspartate aminotransferase > 1.5 times the Upper Lange of normal at screening.
- Patients with a history of drug or alcohol abuse.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Double Blinded, Randomized, Active Drug Comparative, Multi-center, phase3 Clinical Study to Evaluate the Efficacy and Safety of PG201 in Osteoarthritis Patients
The objective of this study was to to evaluate the efficacy and safety of PG201 in osteoarthritis patients.
This clinical study was designated to be non-inferiority test with level of significance: 95%, α=0.05. Type 2 error (β) was set as 0.2, and the power of the test was set as 80%. Assuming 20% drop-out rate, the number of subjects required for each treatment group was estimated to be 154, while the total number of subjects required for the study 308.
non-inferiority margin: 8mm
Read the detailed description
Patients in the PG201 group were prescribed two PG201 tablets per day(BID) and one celecoxib placebo capsule each in the morning and evening per day for 8 weeks.
Patients in the celecoxib group were prescribed celecoxib 200 mg (one 200 mg capsule and one celecoxib placebo capsule) and one PG201 placebo tablet each in the morning and evening per day for 8 weeks.
- Conditions
- Osteoarthritis of the Knee
- Being tested
- PG201 tablet, Celebrex capsule
- Keywords
- PG201, Non-inferiority, 100mm pain VAS
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PG201 tabletDrug
Also called botanical drug
One PG201 tablet and one celecoxib placebo capsule(after breakfast, in 30minutes), One PG201 tablet and one celecoxib placebo capsule(after dinner, in 30minutes)
Celebrex capsuleDrug
Also called chemical drug
One celecoxib capsule and one PG201 placebo tablet(after breakfast, in 30minutes), one celecoxib placebo capsule and one PG201 placebo tablet(after dinner, in 30minutes)
| Study group | Role | What they receive |
|---|---|---|
| PG201 tablet | Experimental | Not described Receives: Drug: PG201 tablet |
| Celecoxib capsule | Active comparator | Not described Receives: Drug: Celebrex capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
100mm Pain VAS reduction
Measured: Screening, Day1, Day28
Secondary outcomes (5)
Pain VAS total score on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Measured: Screening, Day1, Day28
Sub-scale score and total score on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Measured: Screening, Day1, Day28
The change in the quality of life score
Measured: Day1, Day28
The change in the patient self-assessed & investigator-assessed overall symptom scores
Measured: Screening, Day1, Day28
The responder index (RI)
Measured: screening, Day1, Day28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2012 (estimated)
- Study startJan 2010
- Primary completionMar 2011
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis of the KneeStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 309 participants (actual)
Sponsor and investigators
- Lead sponsor
- PMG Pharm Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yeong-wook Song, MD, Principal investigator, Seoul National University HospitalWan-Hee Yoo, MD, Principal investigator, Chonbuk National University HospitalSung-Hwan Park, MD, Principal investigator, The Catholic University of Korea College of MedicineHan-joo Baek, MD, Principal investigator, Gachon University of Medicine and ScienceYun Jong Lee, MD, Principal investigator, Seoul National University Bundang HospitalSeung Cheol Shim, MD, Principal investigator, Eulji UniversitySeong Wook Kang, MD, Principal investigator, Chungnam National University School of MedicineHyun Ah Kim, MD, Principal investigator, Hallym University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01576419
- Sponsor's protocol ID
- PG201-P3
- Status last verified
- Apr 2012
- First submitted
- 4 Apr 2012
- Last updated
- 12 Apr 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double Blinded, Randomized, Active Drug Comparative, Multi-center, phase3 Clinical Study to Evaluate the Efficacy and Safety of PG201 in Osteoarthritis Patients
- ClinicalTrials.gov ID
- NCT01576419
- Acronym / sponsor ID
- PG201-P3
- Conditions
- Osteoarthritis of the Knee
- Keywords
- PG201, Non-inferiority, 100mm pain VAS
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 309 participants (actual)
- Lead sponsor
- PMG Pharm Co., LtdIndustry (pharma, biotech, devices)
- Study start
- Jan 2010
- Primary completion
- Mar 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 12 Apr 2012 (estimated)
- 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 objective of this study was to to evaluate the efficacy and safety of PG201 in osteoarthritis patients.
This clinical study was designated to be non-inferiority test with level of significance: 95%, α=0.05. Type 2 error (β) was set as 0.2, and the power of the test was set as 80%. Assuming 20% drop-out rate, the number of subjects required for each treatment group was estimated to be 154, while the total number of subjects required for the study 308.
non-inferiority margin: 8mm
Detailed description
Patients in the PG201 group were prescribed two PG201 tablets per day(BID) and one celecoxib placebo capsule each in the morning and evening per day for 8 weeks.
Patients in the celecoxib group were prescribed celecoxib 200 mg (one 200 mg capsule and one celecoxib placebo capsule) and one PG201 placebo tablet each in the morning and evening per day for 8 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PG201 tablet | Experimental | Drug: PG201 tablet |
| Celecoxib capsule | Active comparator | Drug: Celebrex capsule |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Patients ≥40 and ≤ 80years of age.
- Patients who meet the American College of Rheumatology clinical plus radiographic classification criteria for idiopathic osteoarthritis of the knee, which are defined as follow:
- a patient who had knee pain and radiographically diagnosed osteophytes and met at least one of the followings.
- Patients with symptomatic primary osteoarthritis of the knee at least in the last 3 months prior to screening.
- Patients who received Nonsteroidal antiinflammatory drugs (NSAIDs)/Cyclooxygenase-2 inhibitor for the treatment of arthritis of the knee for at least 5 days a week during 4 weeks prior to screening.
Key exclusion criteria (8 listed)
- Patients with a history of surgery or arthroscopy of the study joint within the previous 6 months.
- Patients with trauma of study joint within the previous 12 months.
- Patients with symptomatic hip osteoarthritis, other condition that would interfere with study assessments.
- Patients with any other type of arthritis, active malignancies or any active GI, cardiovascular, renal, hepatic, neurologic, or psychiatric disease.
- Patients with a known hypersensitivity or intolerance to Nonsteroidal antiinflammatory drugs (NSAIDs), aspirin or Cyclooxygenase-2 inhibitor.
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 |
|---|---|---|
| PG201 tabletAlso: botanical drugOne PG201 tablet and one celecoxib placebo capsule(after breakfast, in 30minutes), One PG201 tablet and one celecoxib placebo capsule(after dinner, in 30minutes) | Drug | PG201 tablet |
| Celebrex capsuleAlso: chemical drugOne celecoxib capsule and one PG201 placebo tablet(after breakfast, in 30minutes), one celecoxib placebo capsule and one PG201 placebo tablet(after dinner, in 30minutes) | Drug | Celecoxib capsule |
Primary outcome
100mm Pain VAS reduction
Time frame: Screening, Day1, Day28
5 secondary outcomes
Pain VAS total score on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Time frame: Screening, Day1, Day28
Sub-scale score and total score on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Time frame: Screening, Day1, Day28
The change in the quality of life score
Time frame: Day1, Day28
The change in the patient self-assessed & investigator-assessed overall symptom scores
Time frame: Screening, Day1, Day28
The responder index (RI)
Time frame: screening, Day1, Day28
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2012.
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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.
Yeong-wook Song, MD principal investigator
Seoul National University Hospital
Wan-Hee Yoo, MD principal investigator
Chonbuk National University Hospital
Sung-Hwan Park, MD principal investigator
The Catholic University of Korea College of Medicine
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 PG201 tablet and Celebrex capsule in people with Osteoarthritis of the Knee, 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 11 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: finished, as of the sponsor's last update on 12 Apr 2012. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
100mm Pain VAS reduction (time frame: Screening, Day1, Day28). 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 12 Apr 2012.