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A study which will show the equivalence in analgesic efficacy and bowel function taking oxycodone equivalents of 120 and 160 mg per day as achieved with the higher OXN PR tablet strengths (OXN60/30 mg...

Mise à jour : Il y a 4 ans
Référence : EUCTR2013-004888-31

A study which will show the equivalence in analgesic efficacy and bowel function taking oxycodone equivalents of 120 and 160 mg per day as achieved with the higher OXN PR tablet strengths (OXN60/30 mg PR, OXN80/40 mg PR) twice daily compared to the identical daily dose taken as a combination of lower tablet strengths in subjects with non-cancer or cancer pain that requires around-the-clock opioid therapy

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Extrait

Primary objective: To demonstrate equivalence between multiple lower strength OXN PR tablets and a single higher strength OXN PR tablet taken at the same overall total daily dose as shown by: • Analgesic efficacy based on the mean of subjects’ ‘Average Pain over the last 24 hours’ at the last 2 visits of each Cross-over Period, as assessed by the Pain Intensity Scale. Co-primary objective: • Equivalent bowel function as assessed by the Bowel Function Index (BFI).

Critère d'inclusion

  • The intended indication is:
  • Chronic severe non malignant pain, chronic severe malignant pain, requiring opioids

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