At a glance
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A Phase IV, Randomized, Double-Blind, Placebo-Controlled, Single-Center Study of the Effects of Colchicine on Pain and Inflammation in Subjects With Knee Osteoarthritis
In Brief
A Phase 4 clinical trial evaluating Colchicine 0.8 mg or 0.6 mg orally once daily and Placebo oral capsule for Osteoarthritis and Osteo Arthritis Knee. Completed, enrolled 120 participants across 1 site.
Detailed Summary
This prospective, double-blinded, placebo-controlled, randomized trial will enroll 120 SKOA subjects at the NYU Center for Musculoskeletal Care. Patients meeting entry criteria will be randomized 1:1 to treatment with colchicine or placebo daily for 3 months. Subjects will have detailed evaluation of standardized clinical pain outcomes, candidate peripheral blood biomarkers, baseline knee radiographs as well as MSK-US, and a subset will undergo evaluation of their synovial fluid.
Study Details
Timeline
Interventions
Colchicine 0.8 mg orally once daily for 1.5 months, and then 0.6 mg once daily for the remainder of the time (1.5 months)
Placebo 0.8 mg or 0.6 mg orally once daily for 3 months