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A double-blind, active-controlled, randomized, multicenter, parallel-group 2 day comparison of 1000 mg propyphenazone / 80 mg codeine (applied as two suppositories) combination therapy versus a 1000 m...

Mise à jour : Il y a 4 ans
Référence : EUCTR2004-001069-17

A double-blind, active-controlled, randomized, multicenter, parallel-group 2 day comparison of 1000 mg propyphenazone / 80 mg codeine (applied as two suppositories) combination therapy versus a 1000 mg propyphenazone monotherapy (applied as two suppositories) in terms of safety and efficacy in patients suffering from urogenital or biliary pain

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Extrait

The primary objective is to demonstrate the superiority of the combination therapy of propyphenazone and codeine compared to propyphenazone monotherapy with respect to the primary endpoint, the AUC of the pain intensity measured on a 100 mm visual analogue scale within the time period from 1-5 hours after drug application. The pain intensity will be measured every hour within the first 5 hours after drug application.

Critère d'inclusion

  • acute, at least moderate to severe biliary or urogenital pain

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