Study of Pentosan Polysulfate Sodium for Knee Osteoarthritis Pain

This study is looking for adults aged 18 and older with knee osteoarthritis (OA) pain. The goal is to see how well subcutaneous (under the skin) injections of pentosan polysulfate sodium (PPS) work to reduce pain and improve function compared to a placebo (an inactive substance). You would be eligible if you have a clinical and X-ray diagnosis of knee OA. The main way we'll measure success is by tracking changes in your knee pain using a daily pain score over 112 days. Approximately 466 people will participate in this study. The current recruitment status is unclear.

Study design
This is a randomized, double-blind, placebo-controlled study, meaning participants are randomly assigned to receive either the study drug or placebo, and neither you nor your doctor will know which you are receiving. Approximately 466 participants will be enrolled.
What's involved
You would receive subcutaneous injections twice weekly for 6 weeks. The total study duration for each participant is up to 64 weeks, including a 7-week screening period and a 52-week follow-up period with visits every 4-6 weeks.
Compensation
Not stated in the trial record.
Follow-up
After the 6-week treatment period, participants will be followed for 52 weeks, with visits or contacts every 4-6 weeks.

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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.

Recruiting
PHASE3Ages 18+InterventionalTreatment
Paradigm Biopharmaceuticals Ltd.
~466 participants
Updated 2026-05-08 on ClinicalTrials.gov
What's tested:Pentosan Polysulfate Sodium twice weeklyPlacebo

At a glance

Recruiting sites
56 of 56 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change from baseline at Day 112 in knee pain as assessed by the weekly average of daily pain (ADP) score on the numerical rating scale (NRS) 11-point (0-10) scale.
Measured over Baseline, Daily to Day 112
Osteoarthritis, Knee
56 sites across 18 states
Florida10
California7
Texas7
Michigan4
New York4
New South Wales4
Moldova3
Arizona2
  • Chief Medical Officer, Medical · STUDY_DIRECTOR · Paradigm Biopharmaceuticals

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  • Change from baseline at Day 112 in knee pain as assessed by the weekly average of daily pain (ADP) score on the numerical rating scale (NRS) 11-point (0-10) scale.Baseline, Daily to Day 112

    The NRS is an 11-point unidimensional scale for self-report of pain. The participant selects a whole number (0-10) that best reflects the intensity of their pain. The anchors are 0=no pain and 10=extreme pain/worst possible pain. It is often categorised into no pain=0, mild pain=1-3, moderate pain=4-6, severe pain=7-10. Participants will be asked to consider their average pain over the last 24 hours.