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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 · View on ClinicalTrials.gov ↗
Study 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.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Pentosan Polysulfate Sodium twice weekly
Study Locations (20)
Florida
- Arrow Clinical Trials — Daytona Beach
- AGA Clinical Trials — Hialeah
- Well Pharma Medical Research — Miami
- K2 Medical Research — Orlando
- Progressive Medical Research — Port Orange
- Phoenix Clinical Research — Tamarac
- Conquest Research — Winter Park
Michigan
- Profound Research — Farmington Hills
- Insight Research Institute — Flint
- Rochester Medical Group — Rochester Hills
- Onyx Clinical Research - Rochester Hills — Troy
Arizona
- Onyx Clinical Research-Peoria — Peoria
- Del Sol Research Management, LLC — Tucson
California
- Orange County Research Institute — Anaheim
- Core Healthcare Group — Cerritos
Illinois
- Chicago Clinical Research, Inc — Chicago
- Northwestern University — Chicago
New York
- Drug Trials America — Hartsdale
- IMC Clinical Research Manhattan — New York
Nebraska
- Physician Research Collaboration — Lincoln
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 466 participants |
| Start Date | 2025-05-29 |
| Est. Completion | 2027-07 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06917404
The ClinicalTrials.gov registry entry for NCT06917404 describes a study currently listed as recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 466 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Paradigm Biopharmaceuticals, which has 29 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Osteoarthritis, Knee appearing as the primary indexed condition, and to 2 interventions — of which Placebo is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06917404 reports 20 study locations spanning 7 distinct geographic areas — top geographies include Florida, Michigan, Arizona. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT06917404 about?
NCT06917404 is a clinical study titled "A Study to Investigate the Treatment Effect of Subcutaneous Injections of Pentosan Polysulfate Sodium Compared With Placebo in Adult Participants With Knee Osteoarthritis Pain.". 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 tr...
What is the current status of trial NCT06917404?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 466 participants. The study started on 2025-05-29. Estimated completion is 2027-07.
What conditions does trial NCT06917404 study?
This clinical trial studies the following conditions: Osteoarthritis, Knee. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06917404?
The interventions under investigation include: Placebo (DRUG), Pentosan Polysulfate Sodium twice weekly (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06917404?
This trial is sponsored by Paradigm Biopharmaceuticals, which has 29 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT06917404 being conducted?
This trial has 20 study locations across Arizona, California, Florida, Illinois, Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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