Woman and Man
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Extract
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).
Inclusion criteria
- The intended indication is:
- Chronic severe non malignant pain, chronic severe malignant pain, requiring opioids