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Treatment and Duration Effect of Pentosan Polysulfate Sodium (PPS) in Participants With Knee Osteoarthritis Pain

NCT04814719 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 133

Last updated 2025-07-22

No results posted yet for this study

Summary

The purpose of this study is to measure the duration of treatment effect with subcutaneous injections of pentosan polysulfate sodium (PPS) compared with placebo in adult participants with knee osteoarthritis (OA) pain. The study duration will be up to 34 weeks.

Participants who completed pDay 162 of Study PARA\_OA\_002 (i.e. did not discontinue/withdraw prematurely from the parent study) will be invited to participate.

Conditions

  • Osteoarthritis, Knee

Interventions

DRUG

Pentosan Polysulphate Sodium

Subcutaneous Injection (100mg/ml)

DRUG

Placebo (Sodium Chloride Injection, 0.9%)

Placebo to match PPS

Sponsors & Collaborators

  • Paradigm Biopharmaceuticals Ltd.

    lead INDUSTRY

Principal Investigators

  • Thomas Schnitzer · Northwestern University Feinberg School of Medicine

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-06-24
Primary Completion
2024-12-24
Completion
2024-12-24
FDA Drug
Yes

Countries

  • United States
  • Australia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04814719 on ClinicalTrials.gov