PPS Injections for Knee Osteoarthritis
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests the duration of effects from pentosan polysulfate sodium (PPS) injections for individuals with knee osteoarthritis pain. The study compares PPS with a placebo (a saltwater injection) to determine which is more effective. It seeks participants who have completed a related study and experience knee pain from osteoarthritis. This trial may suit those with consistent knee pain from osteoarthritis who participated in the previous study. As a Phase 2 trial, the research focuses on evaluating the treatment's effectiveness in an initial, smaller group of participants.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that pentosan polysulfate sodium (PPS) is generally safe for people with knee osteoarthritis. One study found that a dose of 10 mg/kg of PPS was well tolerated, with participants experiencing no serious side effects. Another study confirmed PPS's safety for treating knee osteoarthritis, suggesting that most people can use it without major problems. While some studies have tested PPS in different forms, such as pills or injections, they consistently demonstrate that the treatment is well-tolerated.12345
Why do researchers think this study treatment might be promising?
Unlike the standard treatments for knee osteoarthritis, which typically involve NSAIDs, corticosteroids, or hyaluronic acid injections, Pentosan Polysulfate Sodium (PPS) targets the disease differently. PPS is derived from a sugar-like compound that may help repair cartilage, offering a novel approach by potentially modifying the disease rather than just relieving symptoms. Researchers are excited about PPS because it is administered subcutaneously, which might offer a more convenient and less invasive alternative to the intra-articular injections commonly used. This unique method of action and delivery gives PPS the potential to change how we approach treatment for knee osteoarthritis.
What evidence suggests that PPS injections might be an effective treatment for knee osteoarthritis?
Research has shown that pentosan polysulfate sodium (PPS), a treatment in this trial, can reduce knee pain in people with osteoarthritis. One study found that participants reported a noticeable decrease in pain, with levels dropping from about 6.4 to 4.2 after six weeks of treatment. Other studies have found that these benefits can last, with pain levels remaining lower even up to 26 weeks. Participants also experienced improved joint movement and quality of life. Overall, PPS appears promising for providing lasting pain relief and better mobility for those with knee osteoarthritis.12678
Who Is on the Research Team?
Thomas Schnitzer
Principal Investigator
Northwestern University Feinberg School of Medicine
Are You a Good Fit for This Trial?
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 for a Trial Participant
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
What Are the Treatments Tested in This Trial?
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 Ltd.
Lead Sponsor
Paradigm Biopharmaceuticals USA (INC)
Lead Sponsor