Knee Osteoarthritis Clinical Trial
Official title:
A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Evaluate the Efficacy of CRx-102 in Subjects With Symptomatic Knee Osteoarthritis and Optional One-Year Extension
CRx-102 is a synergistic combination drug candidate containing the cardiovascular drug
dipyridamole and a very low dose of the glucocorticoid prednisolone. CRx-102 is believed to
work through a novel mechanism of action in which dipyridamole selectively amplifies the
anti-inflammatory and immunomodulatory activities of the glucocorticoid without replicating
the dose-dependent adverse effects.
CRx-102 has been associated with clinical benefit in proof of concept studies in subjects
with hand OA and RA. This is the first study to explore the efficacy of CRx-102 in knee OA.
It is considered a dose-finding study and will also compare the potential benefits of
CRx-102 treatment to both prednisolone administered alone and to placebo in this indication.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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