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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 the Treatme...

Mise à jour : Il y a 4 ans
Référence : EUCTR2006-004513-18

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 the Treatment of Acute Pain From Total Hip Replacement Surgery Followed by a Voluntary Open-Label Extension

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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 48 hours compared to placebo, and to assess the safety and tolerability of multiple doses of CG5503 IR in subjects with acute pain following primary unilateral total hip replacement surgery over the double-blind period.

Critère d'inclusion

  • pain

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