drugset / Trial / NCT06917404

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

NCT06917404 ↗

Phase 3 Recruiting 466 enrolled Paradigm Biopharmaceuticals Ltd.
RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start
2025-05-29
Primary completion
2027-07
Completion
2027-07

Drugs

EvaluationDrugModalityDoseRoute
Comparator Pentosan Polysulfate Sodium Small molecule 2 mg/kg Subcutaneous

Indications