Pentosan Polysulfate Sodium Injections for Osteoarthritis

Recruiting at 36 trial locations

Overseen By Thomas Schnitzer

Age: 18+

Sex: Any

Travel: May Be Covered

Trial Phase: Phase 2 & 3

Sponsor: Paradigm Biopharmaceuticals USA (INC)

Must not be taking: Anticoagulants, Opioids, Corticosteroids, others

Disqualifiers: Bleeding disorders, Fibromyalgia, Cancer, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 17

Duration: 6 weeks

602 Participants Needed

Trial Summary

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.

What data supports the effectiveness of the drug Pentosan Polysulfate Sodium for treating osteoarthritis?

Research shows that Pentosan Polysulfate Sodium can improve knee pain and cartilage health in people with osteoarthritis, and it has been effective in animal studies for reducing inflammation and protecting cartilage. Additionally, it has been used successfully for other conditions like bladder pain syndrome, suggesting its potential benefits for osteoarthritis. ^{1 2 3 4 5}

Is pentosan polysulfate sodium safe for humans?

Pentosan polysulfate sodium has been studied for safety in various conditions, including osteoarthritis and interstitial cystitis. Some studies reported side effects like low platelet counts (thrombocytopenia) and liver enzyme changes at higher doses, but it was generally well-tolerated at recommended doses. ^{2 3 5 6 7}

How is the drug pentosan polysulfate sodium unique for treating osteoarthritis?

Pentosan polysulfate sodium is unique for osteoarthritis treatment because it is administered as an injection, which provides better delivery to tissues like bone and cartilage compared to oral treatments. It is also considered a disease-modifying osteoarthritis drug (DMOAD), meaning it may help improve the condition of the cartilage itself, not just relieve symptoms. ^{2 3 4 5 6}

What is the purpose of this trial?

This trial tests if a new treatment can reduce pain and improve function in people with knee osteoarthritis. The medication aims to reduce inflammation and help repair knee joint damage.

Research Team

Thomas Schnitzer

Principal Investigator

Northwestern University Feinberg School of Medicine

Eligibility Criteria

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

My knee pain scores between 4 to 10 and hurts when I walk or climb stairs.

My knee arthritis is confirmed by X-ray to be moderate to severe.

Painkillers like ibuprofen haven’t helped my pain or I can't take them.

Exclusion Criteria

You have had a bad reaction in the past to PPS, heparin, or similar medications.

I have had a stomach or intestinal ulcer, or signs of bleeding in my digestive tract in the last year.

I have a history of low platelet counts due to an immune response.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

7 weeks

Treatment

Participants receive subcutaneous injections of pentosan polysulfate sodium or placebo for 6 weeks

6 weeks

12 visits (in-person, twice weekly)

Follow-up

Participants are monitored for safety and effectiveness after treatment

18 weeks

5 visits (in-person, every 4 weeks)

Treatment Details

Interventions

• Pentosan Polysulfate Sodium
• Placebo (Sodium Chloride Injection, 0.9%)

Trial Overview The trial is testing if injections of Pentosan Polysulfate Sodium (PPS) are better than placebo at reducing knee pain in osteoarthritis. Participants will receive either PPS once or twice weekly, or a placebo for six weeks and will visit the clinic twice weekly during treatment.

Participant Groups

Group I: PPS Twice Weekly Experimental Treatment 1 Intervention

Pentosan Polysulfate Sodium (PPS) twice weekly for 6 weeks

Group II: PPS Once Weekly Experimental Treatment 2 Interventions

Pentosan Polysulfate Sodium (PPS) + placebo once weekly for 6 weeks

Group III: PPS Fixed Dose Once Weekly Experimental Treatment 2 Interventions

Pentosan Polysulfate Sodium (PPS) Fixed dose (100mg,150mg, or 180mg) once weekly + placebo once weekly for 6 weeks

Group IV: Placebo Placebo Group 1 Intervention

Placebo twice weekly for 6 weeks

Who Is Running the Clinical Trial?

Paradigm Biopharmaceuticals USA (INC)

Lead Sponsor

Trials

2

Recruited

740+

References

1. United States pubmed.ncbi.nlm.nih.gov

The effects of orally administered calcium pentosan polysulfate on inflammation and cartilage degradation produced in rabbit joints by intraarticular injection of a hyaluronate-polylysine complex. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

Pentosan polysulfate sodium for treatment of interstitial cystitis/bladder pain syndrome: insights from a randomized, double-blind, placebo controlled study. [2022]

3. England pubmed.ncbi.nlm.nih.gov

The effect of pentosan polysulfate sodium for improving dyslipidaemia and knee pain in people with knee osteoarthritis: A pilot study. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Dose responsive effects of subcutaneous pentosan polysulfate injection in mucopolysaccharidosis type VI rats and comparison to oral treatment. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Sodium pentosan polysulfate resulted in cartilage improvement in knee osteoarthritis--an open clinical trial. [2023]

6. England pubmed.ncbi.nlm.nih.gov

Pentosan polysulfate promotes proliferation and chondrogenic differentiation of adult human bone marrow-derived mesenchymal precursor cells. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Phase I trial of pentosan polysulfate. [2019]