๐Ÿ›๏ธ Verified NIH Record โ€ข Updated 2026-05-06

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)

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

๐ŸŸข Recruiting Phase3 ๐Ÿ’Š Investigational Drug / Biologic Sponsor: Paradigm Biopharmaceuticals Ltd.

๐Ÿฉบ Plain-English Summary (8th-Grade Level)

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.

Who can join: Review the eligibility criteria below.

Location: Onyx Clinical Research-Peoria โ€” Peoria, Arizona

Age range: 18 Years

๐Ÿงช Interventions in This Study

๐Ÿ“‹ "Do I Qualify?" โ€” 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria โ†—

๐Ÿ“ All Participating Trial Locations (56 Sites)

Showing the first 25 of 56 sites.

  • Onyx Clinical Research-Peoria โ€” Peoria, Arizona
  • Del Sol Research Management, LLC โ€” Tucson, Arizona
  • Orange County Research Institute โ€” Anaheim, California
  • Core Healthcare Group โ€” Cerritos, California
  • Triwest Research Center โ€” Chula Vista, California
  • Seaside Medical Group โ€” Oceanside, California
  • Paragon RX Clinical โ€” Santa Ana, California
  • Encompass Clinical Research โ€” Spring Valley, California
  • Focus Clinical Research โ€” West Hills, California
  • Clinical Research of West Florida - Clearwater โ€” Clearwater, Florida
  • GNP Research โ€” Cooper City, Florida
  • Arrow Clinical Trials โ€” Daytona Beach, Florida
  • AGA Clinical Trials โ€” Hialeah, Florida
  • Evolution Clinical Trials โ€” Miami, Florida
  • Well Pharma Medical Research โ€” Miami, Florida
  • K2 Medical Research โ€” Orlando, Florida
  • Progressive Medical Research โ€” Port Orange, Florida
  • Phoenix Clinical Research โ€” Tamarac, Florida
  • Conquest Research โ€” Winter Park, Florida
  • Chicago Clinical Research, Inc โ€” Chicago, Illinois
  • Northwestern University โ€” Chicago, Illinois
  • Sinai Hospital of Baltimore โ€” Baltimore, Maryland
  • Profound Research โ€” Farmington Hills, Michigan
  • Insight Research Institute โ€” Flint, Michigan
  • Rochester Medical Group โ€” Rochester Hills, Michigan

๐Ÿ“ž Contact the Study Coordinator

Phone: (312) 771-9615

Email: info@paradigmbiopharma.com

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

๐Ÿ’ฐ Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

๐Ÿ’ก How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Contact the study coordinator using the phone/email above.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
๐Ÿ›๏ธ View Official NIH Record โ†—