OXN PR Compared to OxyPR to Demonstrate Non-inferiority in Pain & Locomotor Function & Improvement in Symptoms of Constipation in OA Subjects
OXN PR Compared to OxyPR to Demonstrate Non-inferiority in Pain & Locomotor Function & Improvement in Symptoms of Constipation in OA Subjects
The primary objectives are

 -  to demonstrate that the treatment with OXN PR tablets is non-inferior to the treatment
 with OxyPR with regards to analgesic efficacy and locomotor function.

 -  to demonstrate that subjects with moderate to severe OA pain taking oxycodone/naloxone
 prolonged release tablets have improvement in symptoms of constipation compared to
 subjects taking oxycodone prolonged release tablets alone
Subjects with moderate to severe pain due to osteoarthritis (OA) will be randomised to
 oxycodone/naloxone prolonged release (OXN PR) or oxycodone prolonged release tablets (OxyPR)
 alone to demonstrate that the treatment with OXN PR tablets is non-inferior to the treatment
 with OxyPR with regards to analgesic efficacy and locomotor function and to demonstrate that
 subjects taking OXN PR have improvement in symptoms of constipation compared to subjects
 taking OxyPR alone.
Inclusion criteria:

 -  Moderate to severe chronic nonmalignant OA and that require around-the-clock opioid
 therapy.

 Exclusion criteria:

 -  Females who are pregnant or lactating.

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

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