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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...

Update Il y a 4 ans
Reference: 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

Woman and Man

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Extract

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.

Inclusion criteria

  • The treatment of chronic tumor-related pain

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