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

Paradigm Biopharmaceuticals Pty Ltd0 个研究点目标入组 60 人开始时间: 2021年2月10日最近更新: 2022年2月21日

适应症

试验速览

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•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.

•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.

发起方

Paradigm Biopharmaceuticals Pty Ltd