Oxycodone-naloxone in Relieving Opioid-related Constipation
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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.
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
A Randomised, Double-blind, Parallel-group, Multicentre Study to Demonstrate Improvement in Symptoms of Constipation in Subjects With Non-malignant Pain Taking Oxycodone Equivalent of >20 mg/Day and <50 mg/Day as Oxycodone/Naloxone Prolonged Release Compared to Subjects Taking Oxycodone Prolonged Release Tablets Alone.
Study Start Date
Actual Primary Completion Date
Actual Study Completion Date
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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. [ Time Frame: 12 weeks with a 6 month open label extension ]
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Ages Eligible for Study:
18 Years and older (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Male or female subjects at lest 18 years or older with pain.
Subjects must report constipation caused or aggravated by opioids.
Females who are pregnant or lactating.
Subjects with evidence of significant structural abnormalities of the gastrointestinal (GI) tract (e.g. bowel obstruction, strictures).