Pentosan Polysulfate Sodium for Osteoarthritis
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment, pentosan polysulfate sodium (PPS), to determine if it can reduce pain and improve function in people with knee osteoarthritis. Participants will receive either the PPS treatment or a placebo (a harmless substance with no therapeutic effect) to compare results. It targets individuals who have tried other therapies for knee pain without success and experience significant daily knee discomfort. As a Phase 3 trial, this study represents the final step before potential FDA approval, offering participants the opportunity to contribute to the development of a promising new treatment.
Will I have to stop taking my current medications?
Yes, you will need to stop taking oral and topical NSAIDs and all other systemic pain medications (except allowed rescue medication) from 2 weeks before the study starts until it ends. You can use acetaminophen or certain topical analgesics as rescue therapy if needed.
Is there any evidence suggesting that pentosan polysulfate sodium is likely to be safe for humans?
Research has shown that pentosan polysulfate sodium (PPS) is well-tolerated in past studies. In one study, even at higher doses of 10 mg/kg, PPS did not cause serious drug-related side effects, and participants generally handled it well. This suggests that PPS is safe for use. While the trial under consideration tests a lower dose of PPS, these findings offer some confidence about the treatment's safety.12345
Why do researchers think this study treatment might be promising for osteoarthritis?
Unlike the standard treatments for osteoarthritis, which often include NSAIDs, corticosteroids, or physical therapy, Pentosan Polysulfate Sodium (PPS) offers a novel approach. PPS is unique because it is believed to work by targeting the cartilage and potentially promoting its repair, rather than just alleviating symptoms. Researchers are excited about PPS because it could not only relieve pain but also improve joint function by addressing the root cause of cartilage degradation. This could represent a significant advancement in osteoarthritis treatment, offering hope for long-term improvement rather than just temporary relief.
What evidence suggests that this treatment might be an effective treatment for osteoarthritis?
Research has shown that pentosan polysulfate sodium (PPS), which participants in this trial may receive, can help reduce knee pain in people with osteoarthritis (OA). One study found that participants' knee pain scores significantly dropped from an average of 6.39 to 4.18 after just six weeks of treatment. Participants also reported better physical function and quality of life. Another study found that PPS offers long-lasting pain relief and improved joint function for those with knee OA. These results suggest that PPS could be a promising option for managing knee OA pain and enhancing daily activities.23678
Who Is on the Research Team?
Chief Medical Officer, Medical
Principal Investigator
Paradigm Biopharmaceuticals
Are You a Good Fit for This Trial?
Adults with knee osteoarthritis (OA) pain, diagnosed by specific criteria and X-ray confirmation. Participants must have tried two types of OA therapies unsuccessfully for at least 6 months and report moderate pain levels. They should not be extremely overweight or underweight and agree to use contraception if applicable.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive twice-weekly subcutaneous injections of pentosan polysulfate sodium or placebo
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Pentosan Polysulfate Sodium
Find a Clinic Near You
Who Is Running the Clinical Trial?
Paradigm Biopharmaceuticals Ltd.
Lead Sponsor