A Randomized, Double-Blind, Active- And Placebo-Controlled, Parallel Group, Multicenter Study To Evaluate The Efficacy And Safety of Multiple Doses of CG5503 Immediate Release Formulation In Subjects Awaiting Primary Joint Replacement Surgery for End-Stage Joint Disease

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Extrait

The primary objective of this study is to determine the efficacy of CG5503 immediate-release (IR) using the sum of pain intensity difference (SPID) over 5 days compared with placebo, and to assess the safety and tolerability of multiple doses of CG5503 IR in subjects who are eligible for elective primary total or partial joint replacement of the hip or knee due to chronic osteoarthritis. The null hypothesis is that all CG5503 IR dosage efficacy results are equal to placebo based on 5 day SPID in the treatment of chronic pain from end-stage degenerative joint disease of the hip or knee. The alternative hypothesis is that at least one CG5503 IR dose effect will be different from placebo effect.

Critère d'inclusion

pain

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A Randomized, Double-Blind, Active- And Placebo-Controlled, Parallel Group, Multicenter Study To Evaluate The Efficacy And Safety of Multiple Doses of CG5503 Immediate Release Formulation In Subjects ...