Pentosan Polysulfate Sodium Injections for Osteoarthritis
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests whether pentosan polysulfate sodium, an injectable treatment, can reduce pain and improve function in individuals with knee osteoarthritis. Participants will receive injections either twice a week or once a week for six weeks, and their results will be compared to those receiving a placebo, a non-active treatment. The goal is to determine if this treatment can provide relief for those who haven't found success with other pain therapies like acetaminophen or NSAIDs. Suitable candidates for the trial are individuals with knee osteoarthritis pain that hasn't improved with standard treatments for at least six months. As a Phase 2 trial, this study measures the treatment's effectiveness in an initial, smaller group, offering participants a chance to potentially benefit from a promising new therapy.
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 for acetaminophen/paracetamol, from 2 weeks before the study starts until it ends. You can use acetaminophen/paracetamol or certain topical pain relievers if needed.
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. In one study, participants took a dose of 10 mg per kg of body weight without experiencing serious side effects, indicating the treatment's safety. Another study on PPS injections for knee osteoarthritis also confirmed its safety. These findings suggest that PPS is likely safe to use, with no major adverse events reported.12345
Why are researchers excited about this trial's treatments?
Unlike standard osteoarthritis treatments, which typically focus on pain relief using NSAIDs or corticosteroids, Pentosan Polysulfate Sodium (PPS) offers a novel approach by potentially modifying the disease itself. Researchers are excited because PPS is thought to work by enhancing cartilage repair and reducing inflammation at the joint level. This could not only alleviate symptoms but also slow the progression of osteoarthritis, providing a more comprehensive solution than current treatments. Additionally, the different dosing regimens being explored, such as twice-weekly and fixed-dose options, could offer flexibility and improved patient outcomes.
What evidence suggests that pentosan polysulfate sodium injections could be an effective treatment for knee osteoarthritis?
Research has shown that pentosan polysulfate sodium (PPS) can reduce knee pain and improve movement in people with osteoarthritis. One study found that participants' knee pain scores significantly dropped from 6.39 to about 4 after using PPS. They also reported better joint function and quality of life. These benefits appeared at various times, such as 6, 16, and 26 weeks after starting treatment. In this trial, participants will receive PPS in different dosing schedules or a placebo. Overall, PPS appears to be a promising option for relieving pain and improving movement for those with knee osteoarthritis.12567
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 unresponsive to standard treatments, who have a BMI of 18-35 kg/m2 and can give informed consent. They must not be using certain medications or have conditions that could interfere with the study, such as recent surgery, other joint diseases, or severe allergies.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive subcutaneous injections of pentosan polysulfate sodium or placebo for 6 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Pentosan Polysulfate Sodium
- Placebo (Sodium Chloride Injection, 0.9%)
Find a Clinic Near You
Who Is Running the Clinical Trial?
Paradigm Biopharmaceuticals USA (INC)
Lead Sponsor