Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

ACTIVE NOT RECRUITING Phase 2

Treatment Effects of Subcutaneous Injections of Pentosan Polysulfate Sodium vs Placebo in Participants With Knee OA Pain

NCT04809376 · 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 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

FieldValue
Enrollment Target 602 participants
Start Date 2021-10-19
Est. Completion 2025-01-06
Phase Phase 2

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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. It is categorized as Phase 2, 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 602 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Paradigm Biopharmaceuticals USA (INC), which has 1 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 4 interventions — of which Pentosan Polysulfate Sodium twice weekly 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: NCT04809376 reports 20 study locations spanning 6 distinct geographic areas — top geographies include Florida, California, 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 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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

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. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial