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A randomised, double-blind, active-controlled, double-dummy, parallel group study to determine the safety and efficacy of oxycodone / naloxone prolonged release tablets in subjects with moderate to se...

Mise à jour : Il y a 4 ans
Référence : EUCTR2007-001313-42

A randomised, double-blind, active-controlled, double-dummy, parallel group study to determine the safety and efficacy of oxycodone / naloxone prolonged release tablets in subjects with moderate to severe, chronic cancer pain

Femme et Homme

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Extrait

To determine the improvement in symptoms of constipation in subjects receiving treatment with oxycodone/naloxone prolonged release tablets (OXN) compared to subjects receiving oxycodone prolonged release tablets (OXY) based on the Bowel Function Index (BFI) and laxative use. To demonstrate the comparability of oxycodone / naloxone prolonged release tablets (OXN) and oxycodone prolonged release tablets (OXY) for the management of chronic cancer pain as assessed by the Brief Pain Inventory (BPI) and rescue medication use recorded by subjects.

Critère d'inclusion

  • subjects with moderate to severe, chronic cancer pain

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