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news.NicOx has started a phase III clinical trial for its anti-inflammatory drug naproxcinod in patients with osteoarthritis of the hip.
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The trial is expected to enroll approximately 800 patients at around 100 clinical centers in North America and Europe and is the final phase III trial in NicOx’s plan for regulatory filing.
The objective of the study is to demonstrate naproxcinod’s efficacy in relieving the signs and symptoms of osteoarthritis of the hip and to provide additional safety data, primarily to confirm naproxcinod’s improved blood pressure profile compared to current treatments. Efficacy results are expected mid-2008.
NicOx aims to develop naproxcinod as the first compound in the COX-inhibiting nitric oxide-donating (CINOD) class for treating the signs and symptoms of osteoarthritis.
Maarten Beekman, vice president of clinical development at NicOx, commented: “We believe that confirming naproxcinod’s improved blood pressure profile over current treatments will be a key differentiating factor in the current anti-inflammatory market.”