Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT04809376 · ClinicalTrials.gov registry record · Phase 2
Treatment Effects of Subcutaneous Injections of Pentosan Polysulfate Sodium vs Placebo in Participants With Knee OA Pain
A Phase 2 study of Osteoarthritis, Knee, sponsored by Paradigm Biopharmaceuticals USA (INC).
- Active
- Registry status
- Phase 2
- Development phase
- 602
- Enrollment target
- 20
- Study locations
NCT04809376: Active Phase 2 study of Osteoarthritis, Knee, sponsored by Paradigm Biopharmaceuticals USA (INC).
NCT04809376 is a Phase 2 study of Osteoarthritis, Knee that is active but no longer recruiting, run by Paradigm Biopharmaceuticals USA (INC). The registered enrollment target is 602 participants, above the 492-participant average among 112 other Osteoarthritis, Knee trials with a reported enrollment target (22% higher). The trial reports 20 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04809376, a Phase 2 study of Osteoarthritis, Knee, is active but no longer recruiting, sponsored by Paradigm Biopharmaceuticals USA (INC).
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 602 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 osteoarthritis pain. Study details include: * The study duration will be up to 31 weeks per participant * The treatment duration will be 6 weeks. * The visit frequency will be twice weekly during treatment. * The visit frequency will be every 4 weeks during the follow-up period.
Primary Outcome
WOMAC: The WOMAC® NRS 3.1 Index is a validated, self-administered, health status questionnaire that assesses pain, stiffness, and function in patients with hip or knee OA . The WOMAC pain sub-scale is a 5-item questionnaire used to assess the amount of pain experienced due to OA of index joint (knee) during the past 48 hours. It is calculated as the mean of scores from 5 individual questions scored on a numerical rating scale (NRS). Scores for each question and WOMAC Pain sub-scale score on NRS
Conditions Studied
Interventions
- DRUG Pentosan Polysulfate Sodium twice weekly
- DRUG Placebo (Sodium Chloride Injection, 0.9%)
- DRUG Pentosan Polysulfate Sodium Fixed Dose
- DRUG Pentosan Polysulfate Sodium once weekly
Study Locations (20)
Florida
- Clinical Research of West Florida- Clearwater - Clearwater
- University Clinical Research-Deland - DeLand
- LMG Research - Miami
- Well Pharma Medical Research, Corp. - Miami
- Progressive Medical Research - Port Orange
- Clinical Research of West Florida - Tampa
- Conquest Research - Winter Park
California
- Core Healthcare Group - Cerritos
- Biosolutions Clinical Research Center - La Mesa
- Providence Clinical Research - North Hollywood
- Prospective Research Innovations Inc. - Rancho Cucamonga
- Encompass Clinical Research - Spring Valley
Arizona
- Alliance for Multispecialty Research - Tempe - Tempe
- Fiel Family and Sports Medicine - Tempe
- Tucson Orthopaedic Institute - Tucson
Kansas
- Alliance for Multispecialty Research - Newton - Newton
- Alliance for Multispecialty Research - Wichita West - Wichita
- Alliance for Multispecialty Research - Wichita East - Wichita
Illinois
- Northwestern University Feinberg School of Medicine - Chicago
Louisiana
- Tandem Clinical Research - Marrero
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 602 participants |
| Start Date | 2021-10-19 |
| Est. Completion | 2025-01-06 |
| Phase | Phase 2 |
What the registry record for NCT04809376 still lists
NCT04809376 is an interventional study that assigns participants to a tested intervention. The registered 602 participants enrollment target is mid-sized for trials with a published cap, above the 492-participant average among 112 other Osteoarthritis, Knee trials with a reported enrollment target (22% higher).
The record links to 1 condition, with Osteoarthritis, Knee appearing as the primary indexed condition, and to 4 interventions - of which Pentosan Polysulfate Sodium twice weekly is the first listed.
NCT04809376 names 20 study sites across 6 states, led by Florida, California, Arizona.
Frequently Asked Questions
What is clinical trial NCT04809376 about?
NCT04809376 is a clinical study titled "Treatment Effects of Subcutaneous Injections of Pentosan Polysulfate Sodium vs Placebo in Participants With Knee OA 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 osteoarthritis pain. Study details include: * The study duration will be up to 31 wee...
What is the current status of trial NCT04809376?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 602 participants. The study started on 2021-10-19. Estimated completion is 2025-01-06.
What conditions does trial NCT04809376 study?
This clinical trial studies the following conditions: Osteoarthritis, Knee.
What interventions are being tested in trial NCT04809376?
The interventions under investigation include: Pentosan Polysulfate Sodium twice weekly (DRUG), Placebo (Sodium Chloride Injection, 0.9%) (DRUG), Pentosan Polysulfate Sodium Fixed Dose (DRUG), Pentosan Polysulfate Sodium once weekly (DRUG).
Who is sponsoring clinical trial NCT04809376?
This trial is sponsored by Paradigm Biopharmaceuticals USA (INC), which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04809376 being conducted?
This trial has 20 study locations across Arizona, California, Florida, Illinois, Kansas. 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 NCT04809376's enrollment target sits among peer trials
602 16th of 112 higher than 97 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.
Source ClinicalTrials.gov registry export · 2026-08-08
-
Preventing Injured Knees From osteoArthritis: Severity Outcomes
RECRUITING · Phase 2
-
Generate and Test the Reliability of a PD Model of OXT on Pupillary Hippus as a Measure of CNS Activity
RECRUITING · Phase 2
-
Cannabinoid Interactions With Central and Peripheral Pain Mechanisms in Osteoarthritis of the Knee
RECRUITING · Phase 2
-
Cannabidiol for Postoperative Opioid Reduction in Primary Total Knee Arthroplasty
RECRUITING · Phase 2
-
A Master Protocol Study (LY900028) of Multiple Intervention-Specific-Appendices (ISAs) in Participants With Chronic Pain
RECRUITING · Phase 2
-
A Phase 2b/3a Study to Evaluate the Efficacy and Safety of JointStem in Patients Diagnosed as Knee Osteoarthritis
RECRUITING · Phase 2
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT03849443 · 604 participants · Early Phase 1
Single Versus Multi-Dose Oral and Intravenous Tranexamic Acid Patients at High Risk for Blood Transfusion After Spine Surgery
- NCT05238922 · 604 participants · Phase 1
Study of INCB123667 in Subjects With Advanced Solid Tumors
- NCT06040541 · 604 participants · Phase 1
Study of RMC-9805 in Participants With KRAS G12D-Mutant Solid Tumors
- NCT00004317 · 600 participants · Phase 4
Pyrimethamine, Sulfadiazine, and Leucovorin in Treating Patients With Congenital Toxoplasmosis
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI