NicOx S.A. Initiates Third Pivotal Naproxcinod Phase III Study
NicOx S.A. announced the initiation of the third pivotal Phase III clinical trial (303 study) for naproxcinod in patients with osteoarthritis of the hip.
The 13-week, double-blind, placebo- and naproxen-controlled trial is expected to enroll approximately 800 patients at roughly 100 clinical centers in North America and Europe, NicOx said.
The objective 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 with current treatments, according to the company.
Patients will be randomized to three arms: a naproxcinod 750-mg bid, a placebo bid and a naproxen 500-mg bid. Efficacy results are expected mid-2008, the company said.