Treatment Effects of Subcutaneous Injections of Pentosan Polysulfate Sodium vs Placebo in Participants With Knee OA Pain

Running, not enrolling · Phase 2/Phase 3 · Has a placebo group

Conditions studied: Osteoarthritis, Knee

In brief

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 osteoarthritis pain. Study details include: * The study duration will be up to 31 weeks per participant * The treatment duration will be 6 weeks. * The visit frequency will be twice weekly during treatment. * The visit frequency will be every 4 weeks during the follow-up period.

Key facts

Study ID

NCT04809376

Run by

Paradigm Biopharmaceuticals USA (INC)

People needed

602

Starts

2021-10-19

Expected to finish

2025-01-06

Last updated by the study team

2024-04-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Participant must be >= 18 years of age inclusive, at the time of signing the informed consent.
• Clinical diagnosis of OA in the index knee by American College of Rheumatology criteria 1986 criteria.
• 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.
• Osteoarthritis pain in the index knee unresponsive (ie, the participant still experiences pain) to conservative therapy for ≥ 6 months preceding Screening, defined as history indicating that:
• Acetaminophen/paracetamol therapy has not provided sufficient pain relief or participant is unable to take acetaminophen/paracetamol chronically/long term because of contraindication or inability to tolerate; AND
• At least 1 oral non-steroidal anti-inflammatory drug (NSAID, including cyclooxygenase-2 inhibitors) and/or topical NSAID therapy that has not provided sufficient pain relief or participant is unable to take NSAIDs because of contraindication or inability to tolerate.
• Average WOMAC NRS 3.1 Index pain sub-scale score of 4 to 10 in the index knee at Screening AND a minimum pain score of 4 on either of the individual WOMAC NRS 3.1 Index questions of pain on walking on a flat surface or pain on climbing stairs at Screening.
• Average WOMAC NRS 3.1 Index function sub-scale score of 4 to 10 in the index knee at Screening.
• Body mass index of >=18 to <=39.0 kg/m2
• Female subjects of childbearing potential and Male subjects must agree to comply with protocol specified contraceptive requirements
• Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
• Current non-pharmacologic treatment regimen for knee OA (excluding knee brace) must be stable for at least 2 weeks before Day 1 and remain stable throughout the study. Participant must be willing to abstain from starting a new or changing their non-pharmacologic treatment regimen for the duration of the study.
• Willing to stop treatment with oral and topical NSAIDs, and all other systemic pain medications (except acetaminophen/paracetamol per rescue protocol) from 2 weeks before Day 1 to end of study.
• Agrees to use acetaminophen/paracetamol or topical analgesics (topical NSAIDs are prohibited) as rescue therapy if required.

You may not qualify if…

• Documented or reported history of increased bleeding in the absence of anticoagulant or antiplatelet drugs or prior history of major bleeding episode in the presence of anticoagulant or antiplatelet therapy.
• History of idiopathic or immune-mediated thrombocytopenia including history of or laboratory confirmed HIT (positive or equivocal antibodies against platelet factor 4 [ie, PF4] and positive Serotonin Release Assay (SRA)].
• Currently active or recent history (within preceding 12 months) of a gastric or duodenal ulcer, or suspicion of gastrointestinal tract bleeding.
• History of other bleeding disorders including haemophilia
• . Recent cerebral bleeding or operation on brain, spine, or eyes within 6 months of Day 1.
• Spinal anaesthesia within 14 days of Day 1,
• Fibromyalgia, regional pain caused by lumbar or cervical compression with radiculopathy, or other moderate to severe pain 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.
• History of other disease that may involve the index joint, including inflammatory joint disease such as rheumatoid arthritis, seronegative spondyloarthropathy (eg, ankylosing spondylitis, psoriatic arthritis, inflammatory bowel disease-related arthropathy), crystalline disease (eg, gout), endocrinopathies, metabolic joint diseases, lupus erythematosus, joint infections, Paget's disease, or tumours.
• History of osteonecrosis or osteoporotic fracture (ie, a participant with a history of osteoporosis and a minimally traumatic or atraumatic fracture).
• History of hypersensitivity to PPS, heparin or heparin-like drugs, or drugs of a similar chemical or pharmacological class.
• Predisposition to hypersensitivity due to multiple (2 or more) atopic diseases (such as atopic eczema, asthma, and chronic allergic rhinitis and/or rhinoconjunctivitis) or multiple (2 or more) severe allergies
• Allergy or contraindication to Tetracosactide
• Chronic medical conditions including but not limited to those stated below requiring medical regime changes within 60 days before Day 1. Concurrent unstable peripheral, cardiac, and cerebral vascular disease, poorly controlled chronic obstructive pulmonary disease and asthma, coagulopathies, uncontrolled neurological conditions, active tuberculosis, active infections, symptomatic cardiac arrhythmias, adrenal insufficiency (primary or central), nephrotic syndrome, Cirrhosis (Child-Pugh stage B or C), uncontrolled diabetes and uncontrolled hypothyroidism or hyperthyroidism, or mental or emotional disorders that preclude reliable study participation.
• History of pituitary irradiation or recent (within 1 year) history of transsphenoidal surgery
• Any cancer within the previous 5 years, except for basal cell carcinomas.
• Current hyperkalemia and/or hyponatremia.
• History or current autoimmune polyglandular syndromes
• Presence of any underlying physical or psychological medical condition that, in the opinion of the Investigator, would make it unlikely that the participant will comply with the protocol or complete the study per protocol.
• Current treatment with anticoagulants or antiplatelet drugs, excluding aspirin ≤100 mg/day.
• Previous treatment with PPS in any form.
• Current or recent (within 90 days before Day 1) immunosuppressive or immunomodulatory (with immunosuppressive effects) systemic therapy including but not limited to oral, inhaled, intranasal, intra-articular and topical corticosteroids (occasional use of topical, inhaled or intranasal corticosteroids is acceptable).
• Use of opioids within 6 weeks before Day 1.
• Use of bisphosphonates within 12 weeks before Day 1.
• Use of denosumab and iloprost within 12 weeks before Day 1.
• Use of a knee brace on the index knee within 2 weeks before Day 1.

Where it is running

• Alliance for Multispecialty Research - Tempe — Tempe, Arizona, United States
• Fiel Family and Sports Medicine — Tempe, Arizona, United States
• Tucson Orthopaedic Institute — Tucson, Arizona, United States
• Core Healthcare Group — Cerritos, California, United States
• Biosolutions Clinical Research Center — La Mesa, California, United States
• Providence Clinical Research — North Hollywood, California, United States
• Prospective Research Innovations Inc. — Rancho Cucamonga, California, United States
• Encompass Clinical Research — Spring Valley, California, United States
• Clinical Research of West Florida- Clearwater — Clearwater, Florida, United States
• University Clinical Research-Deland — DeLand, Florida, United States
• LMG Research — Miami, Florida, United States
• Well Pharma Medical Research, Corp. — Miami, Florida, United States
• Progressive Medical Research — Port Orange, Florida, United States
• Clinical Research of West Florida — Tampa, Florida, United States
• Conquest Research — Winter Park, Florida, United States
• Northwestern University Feinberg School of Medicine — Chicago, Illinois, United States
• Alliance for Multispecialty Research - Newton — Newton, Kansas, United States
• Alliance for Multispecialty Research - Wichita West — Wichita, Kansas, United States
• Alliance for Multispecialty Research - Wichita East — Wichita, Kansas, United States
• Tandem Clinical Research — Marrero, Louisiana, United States
• Alliance for Multispecialty Research - Las Vegas — Las Vegas, Nevada, United States
• Kaplan Medical Research — Las Vegas, Nevada, United States
• Coastal Carolina Research Center — North Charleston, South Carolina, United States
• Alliance for Multispecialty Research - Knoxville — Knoxville, Tennessee, United States
• FutureSearch Trials - Austin — Austin, Texas, United States

Full record on ClinicalTrials.gov

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