A randomized withdrawal, active- and placebo-controlled, double-blind, multi-center Phase III trial assessing safety and efficacy of oral CG5503 PR* in subjects with moderate to severe chronic maligna...

Mise à jour : Il y a 4 ans
Référence : EUCTR2007-001985-34

A randomized withdrawal, active- and placebo-controlled, double-blind, multi-center Phase III trial assessing safety and efficacy of oral CG5503 PR* in subjects with moderate to severe chronic malignant tumor-related pain *PR means Prolonged Release and is the recommended nomenclature for use in EU. ER means Extended Release and is the recommended nomenclature for use in USA. "PR" is synonymous with "ER" and is interchangeable in the protocol

Femme et Homme

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Extrait

The primary objective of this trial is to evaluate the safety and efficacy orally administered CG5503 PR tablets BID over 4 weeks (Maintenance phase) in subjects with moderate to severe chronic malignant tumor-related pain in comparison with placebo.


Critère d'inclusion

  • The treatment of chronic tumor-related pain