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A randomised, double-blind, double-dummy, parallel-group multicenter study to demonstrate improvement in symptoms of constipation in subjects with non-malignant pain taking oxycodone equivalent of 60 ...

Update Il y a 4 ans
Reference: EUCTR2005-003510-15

A randomised, double-blind, double-dummy, parallel-group multicenter study to demonstrate improvement in symptoms of constipation in subjects with non-malignant pain taking oxycodone equivalent of 60 - 80 mg/day as oxycodone / naloxone prolonged release (OXN) compared to subjects taking oxycodone prolonged release tablets alone

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Extract

The primary objective of this study is to demonstrate that subjects with moderate to severe non malignant pain taking oxycodone/naloxone prolonged release tablets have improvement in symptoms of constipation as measured by the bowel function index (BFI) compared to subjects taking oxycodone prolonged release tablets alone.

Inclusion criteria

  • Moderate to severe chronic non-malignant pain that requires around-the-clock opioid therapy and also constipation secondary to opioid treatment

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