Status:
COMPLETED
Treatment and Duration Effect of Pentosan Polysulfate Sodium (PPS) in Participants With Knee Osteoarthritis Pain
Lead Sponsor:
Paradigm Biopharmaceuticals Ltd.
Conditions:
Osteoarthritis, Knee
Eligibility:
All Genders
18+ years
Brief 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 osteoar...
Detailed Description
This is an observational study to determine duration of treatment effect and assess long-term safety up to 52 weeks post PPS use for 6 weeks in parent study (PARA\_OA\_002). The duration of treatment ...
Eligibility Criteria
Inclusion
- Participants who completed Day 168 of Study PARA\_OA\_002 (ie, did not discontinue/withdrew prematurely from the parent study).
- Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
Exclusion
- • An employee of the Sponsor, clinical research organisations or research site personnel directly affiliated with this study or their immediate family members defined as a spouse, parent, sibling, or child, whether biological or legally adopted.
Key Trial Info
Start Date :
June 24 2023
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 24 2024
Estimated Enrollment :
133 Patients enrolled
Trial Details
Trial ID
NCT04814719
Start Date
June 24 2023
End Date
December 24 2024
Last Update
July 22 2025
Active Locations (2)
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1
Northwestern University Feinberg School of Medicine
Chicago, Illinois, United States, 60611
2
Emeritus Research
Camberwell, Victoria, Australia, 3124