Knee pain study pulled before it even started
NCT ID NCT01122485
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 2 times
Summary
This study was designed to test whether PG201, a botanical drug, could reduce pain and improve function in people with knee osteoarthritis. It planned to enroll Korean adults aged 40 to 75 and compare two doses of PG201 against a placebo over 8 weeks. However, the trial was withdrawn before any participants were enrolled, so no results are available.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- PG201 (botanical drug)
- What this could lead to
- If it had worked, this could have pointed toward a new herbal option for easing knee pain and stiffness in osteoarthritis.
- What could go wrong
- The trial was withdrawn before enrolling anyone, so no data exists. Even if run, it was a small early-phase study with uncertain benefits.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Expected to start
-
Dec 2006
An estimate. Start dates often move.
- Expected to finish
-
Sep 2009
An estimate. End dates often move.
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
40 to 75 years
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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. * 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 Exclusion Criteria: * 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
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