drugset / Trial / NCT04809376
Treatment Effects of Subcutaneous Injections of Pentosan Polysulfate Sodium vs Placebo in Participants With Knee OA Pain
RandomizedParallel-groupTriple-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 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.
Timeline
- Start
- 2021-10-19
- Primary completion
- 2024-10-15
- Completion
- 2025-01-06
Outcome
Met primary endpoint
release “Paradigm’s Phase 2b clinical trial demonstrated the drug injectable pentosan polysulfate sodium (iPPS) branded as ZilosulÒ was able to reduce pain and improve joint function” paradigmbiopharma.com ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Pentosan Polysulfate Sodium | Small molecule | 1.5 mg/kg | Subcutaneous |
| Subject | Pentosan Polysulfate Sodium | Small molecule | 2 mg/kg | Subcutaneous |
| Subject | Pentosan Polysulfate Sodium | Small molecule | 100 mg | Subcutaneous |
| Subject | Pentosan Polysulfate Sodium | Small molecule | 150 mg | Subcutaneous |
| Subject | Pentosan Polysulfate Sodium | Small molecule | 180 mg | Subcutaneous |