Vizuri Health Sciences announced the initiation of clinical study VZU00025: A Phase 2 Clinical Trial to Examine the Comparative Effects on Osteoarthritic Knee Pain of CGS-200-1 (1% capsaicin content), CGS-200-5 (5% capsaicin content), and CGS-200-0 (placebo).
The ongoing multi-center, randomized, double-blind study will compare the effects of CGS-200-5 (5% capsaicin), CGS-200-1 (1% capsaicin), and CGS-200-0 (vehicle; no capsaicin) on pain in subjects who have osteoarthritis (OA) of the knee as defined by the 1986 American College of Rheumatology criteria. Study subjects will be randomized to receive four consecutive days of either CGS-200-5 (N=40), CGS-200-1 (N=40), or CGS-200-0 (N=40) treatment and will then be followed for an additional 90 days.
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Pain will be assessed throughout using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) and Visual Analogue Scale (VAS) methods. Efficacy, tolerability, and safety assessment data will be collected on Day 1 through Day 5 and then again on Days 19, 35, 64 and 94. Investigators, site staff, and contract personnel will be blinded to treatment assignments throughout the study.
“The filing of the company’s first IND and the initiation of the Phase 2 CGS-200 OA knee pain study are important milestones that underscore our commitment to develop safe, effective, and convenient non-opiate products for the treatment of chronic pain,” William Moore, PhD, Vizuri’s Chief Executive Officer said. “The prescription-strength, CGS-200 capsaicin formulation complements our commercially-available OTC product, PainBloc24. We believe that together these topical capsaicin product formulations will provide osteoarthritis sufferers a spectrum of safe and effective dose-strength options for the management of their nerve pain.”