Osteoarthritis of the KneePhase 2NCT01122485
Efficacy and Safety Study of PG201 Tablet in Patients With Osteoarthritis
A Phase 2 study testing PG201 in people with Osteoarthritis of the Knee, run by Helixmith Co., Ltd..
Trial summary
The objective of this study was to explore the efficacy, dose-response and safety of PG201 tablet in Korean patients with osteoarthritis. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Osteoarthritis of the Knee
- What is being tested?
- PG201
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Dec 2006to Sep 2009
- Phase
- Phase 2
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients ≥40 and ≤ 75 years of age
- For a woman, she should meet one of the following criteria to be eligible for the study: i) A woman of no childbearing potential ii) As for a woman of childbearing potential, she should have a negative pregnancy test result at screening and baseline/randomization
- Patients should be able and willing to provide the written informed consent.
- Patients should be able to read and understand the information provided for the study and be able to record the information requested by the study.
- 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. i) Age> 50 years ii) Morning stiffness for less than 30 minutes iii) Crepitus during movement of the weight-bearing knee
- Patients with symptomatic primary osteoarthritis of the knee at least in the last 3 months prior to screening.
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- Patients with severity of grade 2 or 3 according to Kellgren \& Lawrence scale based on anteroposterior radiographic evidence of the tibiofemoral joints with osteoarthritis, and who are classified in functional class of I, II or III according to the American Rheumatism Association functional classification.
- Patients who had a score of the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscale question 1 ≤80 mm at screening, a score of the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscale question 1 ≥50 mm at baseline. a decrease in the score of the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscale question 1 at least by 15mm from screening to baseline and a decrease in the patient self-assessed arthritis symptoms scores at least by one point from screening to baseline.
- 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
Who cannot join
- Patients with a known hypersensitivity or intolerance to Nonsteroidal antiinflammatory drugs (NSAIDs), aspirin or Cyclooxygenase-2 inhibitor.
- Patients with a clinical or biochemical abnormal finding (excluding any finding related to the investigating disease) at the screening visit, which in the investigator's opinion was considered to be clinically significant or might make safe participation in the study more difficult
- Patients with a history of gastroduodenal perforation and/or occlusion, gastric or duodenal surgery, progressive upper gastrointestinal ulcer within the last 6 months or a history of upper gastrointestinal bleeding (including hematemesis) within the last one year, lower gastrointestinal bleeding within the last one year (excluding hemorrhoid), inflammatory intestinal disease within the last 6 months, coronary artery disease, congestive heart failure or renal artery stenosis, stroke or transient ischemic attack.
- Patients with uncontrollable hypertension
- Patients receiving aspirin therapy (low-dose aspirin in a daily dose of 325mg or less is permitted for prevention of cardiovascular disease).
- Patients receiving anticoagulant drug or antiplatelet drug (excluding low-dose aspirin) or who have a disease associated with hemostatic disorder.
- Patients with any of creatinine, bilirubin, Alanine aminotransferase or Aspartate aminotransferase > 1.5 times the Upper Lange of normal at screening. Patients who have any two or more of bilirubin, Alanine aminotransferase or Aspartate aminotransferase level greater than the Upper Lange of normal will also be excluded.
- Patients with a history of drug or alcohol abuse.
About this study
Official title: For an 8-week, Single Center, Randomized, Double Blind, Placebo Controlled Exploratory Clinical Study to Assess the Efficacy, Dose Response and Safety of PG201 Tablet in Patients With Osteoarthritis
The objective of this study was to explore the efficacy, dose-response and safety of PG201 tablet in Korean patients with osteoarthritis.
Read the detailed description
In this study, the PG201 extract, the study drug, was administered twice daily after a meal to two investigational groups, the lower-dose group and the higher-dose group. The efficacy of each of dose group was compared to that of the control group to determine if there was a statistically significant difference between the investigational groups and the placebo group. In addition, the efficacy between the lower dose group and the high dose group was also compared to determine if there was a statistically significant difference.
- Conditions
- Osteoarthritis of the Knee
- Being tested
- PG201, 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.
PG201Other
Also called Botanical drug
two tablets
PlaceboOther
Also called control drug(placebo)
two tablets
| Study group | Role | What they receive |
|---|---|---|
| Low dose group | Experimental | two tablets per dose (one tablet of investigational drug and one tablet of placebo) Receives: Other: PG201 |
| High dose group | Experimental | two tablets per dose (two tablets of investigational drug) Receives: Other: PG201 |
| Control group | Placebo comparator | two tablets per dose (two tablets of placebo) Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain score on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Measured: Day 56
Secondary outcomes (6)
Sub-scale score and total score on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Measured: Day 28
The responder index (RI)
Measured: Screening, Day 1, Day 28
The change in the quality of life score
Measured: Day 1, Day 28
The change in the patient self-assessed overall symptom scores
Measured: Screening, Day 1, Day 28
The change in the investigator-assessed overall symptom scores
Measured: Screening, Day 1, Day 28
Adverse event, and the presence and incidence of abnormal laboratory
Measured: Screening, Day 1, Day 28, Day 56
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2010 (estimated)
- Study startDec 2006 (estimated)
- Primary completionSep 2009 (estimated)
- Study completionSep 2009 (estimated)
Why it stopped: This product was licensed to another Korean company, no study data is available.
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Helixmith Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- S.H. Park, M.D., Principal investigator, Dept. of Rheumatology, Seoul St. Mary's Hospital, The Catholic University of Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01122485
- Sponsor's protocol ID
- PG201-PT-001
- Status last verified
- Aug 2025
- First submitted
- 6 May 2010
- Last updated
- 25 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- For an 8-week, Single Center, Randomized, Double Blind, Placebo Controlled Exploratory Clinical Study to Assess the Efficacy, Dose Response and Safety of PG201 Tablet in Patients With Osteoarthritis
- ClinicalTrials.gov ID
- NCT01122485
- Acronym / sponsor ID
- PG201-PT-001
- Conditions
- Osteoarthritis of the Knee
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: This product was licensed to another Korean company, no study data is available.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Helixmith Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Dec 2006 (estimated)
- Primary completion
- Sep 2009 (estimated)
- Study completion
- Sep 2009 (estimated)
- First posted
- 13 May 2010 (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 explore the efficacy, dose-response and safety of PG201 tablet in Korean patients with osteoarthritis.
Detailed description
In this study, the PG201 extract, the study drug, was administered twice daily after a meal to two investigational groups, the lower-dose group and the higher-dose group. The efficacy of each of dose group was compared to that of the control group to determine if there was a statistically significant difference between the investigational groups and the placebo group. In addition, the efficacy between the lower dose group and the high dose group was also compared to determine if there was a statistically significant difference.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Low dose group | Experimental | Other: PG201two tablets per dose (one tablet of investigational drug and one tablet of placebo) |
| High dose group | Experimental | Other: PG201two tablets per dose (two tablets of investigational drug) |
| Control group | Placebo comparator | Other: Placebotwo tablets per dose (two tablets of placebo) |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patients ≥40 and ≤ 75 years of age
- For a woman, she should meet one of the following criteria to be eligible for the study: i) A woman of no childbearing potential ii) As for a woman of childbearing potential, she should have a negative pregnancy test result at screening and baseline/randomization
- Patients should be able and willing to provide the written informed consent.
- Patients should be able to read and understand the information provided for the study and be able to record the information requested by the study.
- 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. i) Age> 50 years ii) Morning stiffness for less than 30 minutes iii) Crepitus during movement of the weight-bearing knee
Key exclusion criteria (8 listed)
- Patients with a known hypersensitivity or intolerance to Nonsteroidal antiinflammatory drugs (NSAIDs), aspirin or Cyclooxygenase-2 inhibitor.
- Patients with a clinical or biochemical abnormal finding (excluding any finding related to the investigating disease) at the screening visit, which in the investigator's opinion was considered to be clinically significant or might make safe participation in the study more difficult
- Patients with a history of gastroduodenal perforation and/or occlusion, gastric or duodenal surgery, progressive upper gastrointestinal ulcer within the last 6 months or a history of upper gastrointestinal bleeding (including hematemesis) within the last one year, lower gastrointestinal bleeding within the last one year (excluding hemorrhoid), inflammatory intestinal disease within the last 6 months, coronary artery disease, congestive heart failure or renal artery stenosis, stroke or transient ischemic attack.
- Patients with uncontrollable hypertension
- Patients receiving aspirin therapy (low-dose aspirin in a daily dose of 325mg or less is permitted for prevention of cardiovascular disease).
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 |
|---|---|---|
| PG201Also: Botanical drugtwo tablets | Other | High dose group, Low dose group |
| PlaceboAlso: control drug(placebo)two tablets | Other | Control group |
Primary outcome
Pain score on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Time frame: Day 56
6 secondary outcomes
Sub-scale score and total score on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Time frame: Day 28
The responder index (RI)
Time frame: Screening, Day 1, Day 28
The change in the quality of life score
Time frame: Day 1, Day 28
The change in the patient self-assessed overall symptom scores
Time frame: Screening, Day 1, Day 28
The change in the investigator-assessed overall symptom scores
Time frame: Screening, Day 1, Day 28
Adverse event, and the presence and incidence of abnormal laboratory
Time frame: Screening, Day 1, Day 28, Day 56
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2025.
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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.
S.H. Park, M.D. principal investigator
Dept. of Rheumatology, Seoul St. Mary's Hospital, The Catholic University of Korea
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing PG201 in people with Osteoarthritis of the Knee, run by Helixmith Co., Ltd..
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 9 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: withdrawn, as of the sponsor's last update on 25 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 was withdrawn before enrolling participants, so there are no results.
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?
Pain score on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) (time frame: Day 56). 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 25 Sep 2025.