An Exploratory Phase 2, Randomised, Double-blind, Placebo-controlled Study to Evaluate the Treatment Effect of Pentosan Polysulfate Sodium Compared with Placebo on Synovial Fluid Biomarkers in Participants with Knee Osteoarthritis Pai

Phase 2

Recruiting

• Conditions: Knee Osteoarthritis; Musculoskeletal - Osteoarthritis; Musculoskeletal - Other muscular and skeletal disorders; Inflammatory and Immune System - Other inflammatory or immune system disorders

• Registration Number: ACTRN12621000136808
• Lead Sponsor: Paradigm Biopharmaceuticals Pty Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-02-10
• Last Update Posted: 21 February 2022

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Subjects with a clinical diagnosis of osteoarthritis in one or both knees and a radiographic diagnosis of knee osteoarthritis showing a Kellgren-Lawrence score 2, 3 or 4
Symptomatic pain for at least 6 months preceding screening
Males and females aged greater than or equal to 18 years, who are willing and able to comply with study requirements
Subjects must be able to provide written informed consent
Body Mass Index (BMI) of 18 to 35.0 kg/m2 inclusive
Females of non child-bearing potential or females and males willing to comply with medically acceptable contraceptive requirements of the study
Additional inclusion criteria apply.

Exclusion Criteria

Documented or reported history of increased bleeding in the absence of anticoagulant or antiplatelet drugs, or prior history of major bleeding episode in the presence of anticoagulant or antiplatelet therapy.
History of idiopathic or immune-mediated thrombocytopenia including history of or laboratory-confirmed heparin-induced thrombocytopenia (HIT; positive or equivocal antibodies against platelet factor 4 [ie, PF4]).
Current treatment with anticoagulants or antiplatelet drugs, excluding aspirin less than or equal to 100 mg/day.
Previous treatment with PPS in any form.
Currently active or recent history (within preceding 12 months) of a gastric or duodenal ulcer, or suspicion of gastrointestinal tract bleeding.
Activated partial thromboplastin time [aPTT]) > upper limit of normal (ULN), platelets <150,000/µL, or liver enzyme tests (aspartate aminotransferase [AST], alanine aminotransferase [ALT]) greater than or equal to 2 × ULN at screening.
Additional exclusion criteria apply.

Study & Design

• Study Type: Interventional
• Study Design: Not specified