Pentosan Polysulfate Sodium Injections for Osteoarthritis

Recruiting at36 trial locations

Overseen by Thomas Schnitzer

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2 & 3

Waitlist Available

Sponsor: Paradigm Biopharmaceuticals USA (INC)

Prior Safety Data

Trial Summary

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.

Treatment Details

Interventions

• Pentosan Polysulfate Sodium (Glycosaminoglycan (GAG) Analog)
• Placebo (Sodium Chloride Injection, 0.9%) (Drug)

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+