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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: Recruiting Phase 3 study of Osteoarthritis, Knee, sponsored by Paradigm Biopharmaceuticals.
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, roughly in line with the 494-participant average among 112 other Osteoarthritis, Knee trials with a reported enrollment target. The trial reports 20 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
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.
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 |
What NCT06917404 shows while recruiting
NCT06917404 is an interventional study that assigns participants to a tested intervention. The registered 466 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 494-participant average among 112 other Osteoarthritis, Knee trials with a reported enrollment target.
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 names 20 study sites across 7 states, led by 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.
Learn More About Clinical Trials
Similar trials for Osteoarthritis, Knee
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06917404's enrollment target sits among peer trials
466 20th of 112 higher than 93 of 112 other Osteoarthritis, Knee trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Osteoarthritis, Knee trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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