PPS Injections for Knee Osteoarthritis
Trial Summary
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications.
What data supports the effectiveness of the drug Pentosan Polysulphate Sodium (PPS) for knee osteoarthritis?
Is Pentosan Polysulfate Sodium (PPS) safe for humans?
Pentosan Polysulfate Sodium (PPS) has been studied for safety in humans, showing some potential side effects. In a study for bladder pain syndrome, it was compared to a placebo, and in another study, it was evaluated for knee osteoarthritis. However, in dogs, PPS injections caused temporary bleeding after surgery, suggesting it might affect blood clotting, so caution is advised.34678
How is the drug Pentosan Polysulphate Sodium (PPS) unique for treating knee osteoarthritis?
Pentosan Polysulphate Sodium (PPS) is unique for treating knee osteoarthritis because it is administered through subcutaneous injections (under the skin), which may provide better delivery to tissues like bone and cartilage compared to oral treatments. This method has shown effectiveness in reducing symptoms like pain and stiffness in both animal and human studies.13459
What is the purpose of this trial?
The purpose of this study is to measure the duration of treatment effect with subcutaneous injections of pentosan polysulfate sodium (PPS) compared with placebo in adult participants with knee osteoarthritis (OA) pain. The study duration will be up to 34 weeks.Participants who completed pDay 162 of Study PARA_OA_002 (i.e. did not discontinue/withdraw prematurely from the parent study) will be invited to participate.
Research Team
Thomas Schnitzer
Principal Investigator
Northwestern University Feinberg School of Medicine
Eligibility Criteria
Adults with knee osteoarthritis pain who completed a previous study (PARA_OA_002) without early withdrawal can join. They must consent to the trial's rules and agree to use only paracetamol or topical analgesics for additional pain relief, avoiding topical NSAIDs.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Observational Follow-up
Participants are monitored for the duration of treatment effect and long-term safety of PPS
End of Study
Final assessments and evaluations are conducted at the end of the study
Treatment Details
Interventions
- Pentosan Polysulphate Sodium
- Placebo (Sodium Chloride Injection, 0.9%)
- Subcutaneous Injections
Find a Clinic Near You
Who Is Running the Clinical Trial?
Paradigm Biopharmaceuticals USA (INC)
Lead Sponsor