Femme et Homme
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Extrait
1. To demonstrate that subjects taking OXN PR have improvement in symptoms of constipation as measured by the Bowel Function Index (BFI) compared to subjects taking OxyPR. 2. To demonstrate non-inferiority of OXN PR compared to OxyPR with respect to the analgesic efficacy based on the subjects' "Average Pain over last 24 Hours" assessed at each Double-blind Phase visit as measured by the Pain Intensity Scale.
Critère d'inclusion
- The intended indication is:,Severe pain, which can be adequately managed only with opioid analgesics. The opioid antagonist naloxone is added to counteract opioid-induced constipation by blocking the action of oxycodone at opioid receptors locally in the gut