Pain
Conditions
Keywords
A randomised, double blind, parallel group, multicentre study to demonstrate improvement in symptoms of constipation in subjects with non malignant pain, Moderate to severe chronic non-malignant pain
Brief summary
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.
Detailed description
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.
Interventions
DRUGOxycodone nalaxone prolonged release tablets (OXN)
Sponsors
Mundipharma Research GmbH & Co KG
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | 12 weeks with a 6 month open label extension |
Outcome results
None listed