A Study to Demonstrate Improvement in Symptoms of Constipation in Subjects That Require Around-the-clock Opioid Pain Killer Therapy
A Study to Demonstrate Improvement in Symptoms of Constipation in Subjects That Require Around-the-clock Opioid Pain Killer Therapy
The primary research objective is 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 tablets alone with cancer and non-cancer related pain without reducing
 the effectiveness of pain relief as measured by the Brief Pain Inventory (BPI).
The study OXN3506 is a multicentre, multiple-dose, randomised, double-blind, double-dummy,
 active-controlled, parallel-group study in male and female subjects with non-malignant or
 malignant pain requiring opioids to assess analgesic efficacy and symptoms of constipation
 secondary to opioid treatment. Subjects will be randomised to two treatment groups and will
 be treated with OXN PR or OxyPR for up to 5 weeks. The study is composed of three phases, a
 pre-randomisation phase, a double-blind phase and an extension phase.
Inclusion Criteria

 -  Subjects who are receiving WHO step III opioid analgesic medication for the treatment
 of non-malignant or malignant pain.

 -  Documented history of non-malignant or malignant pain that requires around-the-clock
 opioid therapy

 Exclusion Criteria

 -  Females who are pregnant or lactating.

 -  Subjects with evidence or significant structural abnormalities of the gastrointestinal
 tract.

 -  Subjects with evidence of impaired liver/kidney function upon entry into the study.