Oxycodone-naloxone in Relieving Opioid-related Constipation
Oxycodone-naloxone in Relieving Opioid-related Constipation
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 compared to subjects taking oxycodone prolonged release tablets
 alone.
Patients with a documented history of moderate to severe non-malignant pain that require
 around the clock opioid therapy will be randomised to an oxycodone or an oxycodone-naloxone
 treatment arm to assess the safety and efficacy of oxycodone/naloxone prolonged release
 compared to oxycodone prolonged-release in relieving opioid-related constipation.
Inclusion Criteria:

 -  Male or female subjects at lest 18 years or older with pain.

 -  Subjects must report constipation caused or aggravated by opioids.

 Exclusion Criteria:

 -  Females who are pregnant or lactating.

 -  Subjects with evidence of significant structural abnormalities of the gastrointestinal
 (GI) tract (e.g. bowel obstruction, strictures).