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NCT06917404 · ClinicalTrials.gov registry record · Phase 3
A Study to Investigate the Treatment Effect of Subcutaneous Injections of Pentosan Polysulfate Sodium Compared With Placebo in Adult Participants With Knee Osteoarthritis Pain.
A Phase 3 study of Osteoarthritis, Knee, sponsored by Paradigm Biopharmaceuticals.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 466
- Enrollment target
- 20
- Study locations
NCT06917404 is a Phase 3 study of Osteoarthritis, Knee that is actively recruiting participants, run by Paradigm Biopharmaceuticals. The registered enrollment target is 466 participants, below the 575-participant average among 91 other Osteoarthritis, Knee trials with a reported enrollment target (19% lower). The trial reports 20 study locations across 7 states.
The verdict
NCT06917404, a Phase 3 study of Osteoarthritis, Knee, is actively recruiting participants, sponsored by Paradigm Biopharmaceuticals.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 466 participants
- Enrollment target
- 20
- Study locations
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 |
Interested in This Trial?
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, categorized as Phase 3. The registered enrollment target is 466 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 575-participant average among 91 other Osteoarthritis, Knee trials with a reported enrollment target (19% lower). The listed sponsor is Paradigm Biopharmaceuticals, which has 2 total studies on file at ClinicalTrials.gov.
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.
NCT06917404 reports 20 study locations spanning 7 distinct geographic areas - top geographies include Florida, Michigan, Arizona.
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.
What interventions are being tested in trial NCT06917404?
The interventions under investigation include: Placebo (DRUG), Pentosan Polysulfate Sodium twice weekly (DRUG).
Who is sponsoring clinical trial NCT06917404?
This trial is sponsored by Paradigm Biopharmaceuticals, which has 2 total clinical trials registered on ClinicalTrials.gov.
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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Read our methodology - how this data is sourced, computed, and verified.
Related
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