RecruitingOsteoarthritis, Knee

A Study to Investigate the Treatment Effect of Subcutaneous Injections of Pentosan Polysulfate Sodium Compared With Placebo in Adult Participants With Knee Osteoarthritis Pain.

Eligible age

18+ yrs

Accepts

All genders

Locations

11 states

Healthy volunteers

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About this study

The purpose of this study is to measure the change in pain and function with subcutaneous injections of pentosan polysulfate sodium (PPS) compared with subcutaneous injections of placebo in participants with knee OA pain. Study details include: * The study duration will be up to 64 weeks. * The treatment duration will be 6 weeks. * The visit frequency will be twice weekly during treatment. * The visit/contact frequency will be every 4-6 weeks during the 52-week Follow-up period. * Approximately 466 participants will be enrolled into this study.

Sponsor: Paradigm Biopharmaceuticals Ltd.

You may qualify if…

✓ 1. Participant must be ≥18 years of age inclusive, at the time of signing the informed consent.
✓ 2. Clinical diagnosis of OA in the index knee by American College of Rheumatology 1986 criteria.
✓ 3. Radiographic diagnosis (confirmed by radiologist) of knee OA classified K-L grade 2, 3, or 4 on standing anterior-posterior X-ray of the index knee.
✓ 4. Participant is unresponsive for at least 6 months preceding Screening to any two combinations of OA therapies (one from each A and B) within the last 12 months that include: A.) conservative non-pharmacologic therapy (exercise, weight loss, physical therapy) or simple analgesics (e.g., acetaminophen) and B.) pharmacological treatment (topical or oral NSAIDs \[or cyclooxygenase (COX) inhibitor\], or intra-articular \[IA\] injections), or participant is unable to take NSAIDs because of contraindication or inability to tolerate.
✓ 5. Average daily pain (ADP) numerical rating scale (NRS) score of 4-9 in the index knee at Screening.
✓ 6. Baseline average weekly ADP NRS score of 4-9 in the index knee in the 7 days prior to randomization.
✓ 7. No more than one 24-hr average pain score (0-10 NRS) reported as "10" during the 7 days prior to Day 1.
✓ 8. Body mass index of ≥18.0 to ≤39.0 kg/m2.

You may not qualify if…

✕ 1. History of idiopathic or immune-mediated thrombocytopenia including history of HIT with or without thrombosis.
✕ 2. History of major bleeding disorders including haemophilia.
✕ 3. Currently active or recent history (within preceding 12 months) of a gastric or duodenal ulcer, or suspicion of gastrointestinal tract bleeding.
✕ 4. Recent cerebral bleeding or operation on brain, spine, or eyes within 12 months of Day 1.
✕ 5. Spinal anaesthesia within 14 days of Day 1.
✕ 6. Fibromyalgia, regional pain caused by lumbar or cervical compression with radiculopathy, or other moderate to severe pain disorder that may confound assessments or self-evaluation of the pain associated with osteoarthritis. Participants with a present (current) history of sciatica are not eligible for participation. Participants with a history of sciatica who have been asymptomatic for ≥3 months and who have no evidence of radiculopathy or sciatic neuropathy on thorough neurologic examination are eligible for participation.
✕ 7. History of other disease that may involve the index knee, including inflammatory joint disease such as rheumatoid arthritis (RA), seronegative spondyloarthropathy (e.g., ankylosing spondylitis, psoriatic arthritis, inflammatory bowel disease-related arthropathy), crystalline disease (e.g., gout), endocrinopathies, metabolic joint diseases, lupus erythematosus, joint infections, Paget's disease, or tumours.
✕ 8. History of hypersensitivity to PPS, heparin or heparin-like drugs, or drugs of a similar chemical or pharmacological class.