Clinical Trial Overview: Evaluating Pentosan Polysulfate Sodium for Knee Osteoarthritis PainTrial NamePARA OA 012: A Phase 3, Randomised, Double-Blind, Placebo-Controlled Multi-Centre Study to Evaluate the Treatment Effect of Pentosan Polysulfate Sodium Compared to Placebo in Participants with Knee Osteoarthritis Pain. The Purpose of the StudyThe primary goal of this study is to determine if Pentosan Polysulfate Sodium (PPS) is safe and effective in reducing pain and improving physical function in adults with moderate-to-severe knee osteoarthritis (OA). Previous Phase 2 research suggested that PPS may provide clinically meaningful pain relief that is maintained long after the treatment period. What is Pentosan Polysulfate Sodium (PPS)?PPS is a semi-synthetic carbohydrate derivative that mimics natural substances in the body called glycosaminoglycans. It is being investigated for its potential anti-inflammatory and regenerative properties in joints. Unlike daily pain medications, PPS is administered as a subcutaneous injection (under the skin) twice a week for a limited 6-week period. Who Can Participate?You may be eligible to participate if you:Are an adult participant with a confirmed diagnosis of knee osteoarthritis. Experience significant knee pain that impacts your daily activities. Are willing to stop using other NSAIDs (like ibuprofen or naproxen) and standard pain medications during the trial, using only the study-provided rescue medication if needed. Do not have a history of major bleeding disorders, Heparin-Induced Thrombocytopenia (HIT), or specific eye conditions such as macular degeneration. What to Expect During the TrialStudy Design: Participants are randomly assigned (1:1 ratio) to receive either the active study drug (PPS) or a placebo. Treatment Phase: You will receive injections twice weekly for 6 weeks (a total of 12 injections). Monitoring: Participants will use an electronic diary to record their daily pain levels. Safety monitoring includes regular blood tests, physical exams, and comprehensive eye examinations to monitor for any potential side effects. Duration: Total participation lasts approximately 13 to 14 months (up to Day 404), including the screening process, the 6-week treatment phase, and several follow-up visits to track long-term progress. Why Participate?By joining this study, you will receive specialized care from osteoarthritis experts and contribute to the development of a potential new treatment for a condition that currently has limited non-surgical options. While results can vary, earlier studies showed that participants receiving PPS experienced improved joint function and a reduction in pain that lasted well beyond the final injection.