Clinical Trial

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

Recruiting Phase 3
View on ClinicalTrials.gov →
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.
Protocol Amendment History 2 changes
notable Trial sites expanded: 52 -> 56 locations 2026-05-09
notable Trial sites expanded: 48 -> 52 locations 2026-05-01
Trial Details
NCT Number NCT06917404
Lead Sponsor Paradigm Biopharmaceuticals Ltd.
Conditions Osteoarthritis, Knee
Enrollment 466 participants
Start Date 2025-05-29
Primary Completion 2027-07 (estimated)
Study Completion 2027-07 (estimated)
Updated on ClinicalTrials.gov 2026-05-08