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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 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, roughly in line with the 573-participant average among 91 other Osteoarthritis, Knee trials with a reported enrollment target. The trial reports 20 study locations across 6 states.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04809376
The ClinicalTrials.gov registry entry for NCT04809376 describes a study currently listed as active not recruiting, categorized as Phase 2. The registered enrollment target is 602 participants, a figure that helps gauge the scale of data the investigators plan to collect, roughly in line with the 573-participant average among 91 other Osteoarthritis, Knee trials with a reported enrollment target. The listed sponsor is Paradigm Biopharmaceuticals USA (INC), which has 1 total studies on file at ClinicalTrials.gov.
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 reports 20 study locations spanning 6 distinct geographic areas - top geographies include 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.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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