A Phase 3, Randomised, Double-Blind, Placebo-Controlled Multi-Centre Study to Evaluate the Treatment Effect of Pentosan Polysulfate Sodium Compared to Placebo in Participants With Knee Osteoarthritis Pain
Paradigm Biopharmaceuticals Ltd.
Summary
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.
Description
This is a randomised, double-blind, placebo-controlled, multicenter study that will evaluate the dose and treatment effect of PPS in participants with knee OA pain. Participants will be randomised 1:1 to receive twice-weekly subcutaneous (SC) injections of 2 mg/kg PPS or placebo for 6 weeks. An interim analysis for a potential early conclusion is planned after approximately 50% of participants complete Day 112. The primary analysis will be conducted when all participants complete Day 112. A final analysis will be conducted when the last participant reaches Day 404. The maximum duration for…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 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, wei…
Interventions
- DrugPentosan Polysulfate Sodium twice weekly
Subcutaneous injection, 2 mg/kg twice weekly for 6 weeks
- DrugPlacebo
Placebo, subcutaneous injection, twice weekly for 6 weeks
Locations (56)
- Onyx Clinical Research-PeoriaPeoria, Arizona
- Del Sol Research Management, LLCTucson, Arizona
- Orange County Research InstituteAnaheim, California
- Core Healthcare GroupCerritos, California
- Triwest Research CenterChula Vista, California
- Seaside Medical GroupOceanside, California