Pain
Conditions
Keywords
A randomised, double-blind, double-dummy, parallel-group multicentre study to demonstrate improvement in symptoms of constipation, Moderate to severe, chronic non-malignant pain
Brief summary
The primary objective is to demonstrate that patients 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. The primary objective is to demonstrate that patients taking oxycodone/naloxone prolonged release tablets have improvement in symptoms of constipation compared to subjects taking oxycodone prolonged release tablets alone.
Interventions
Sponsors
Mundipharma Research GmbH & Co KG
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male or female subjects at least 18 years or older with moderate to severe pain that requires around the clock opioid therapy. Subjects must report constipation caused or aggravated by opioids.
Exclusion criteria
* Females who are pregnant or lactating. * Subjects with evidence of any clinically unstable disease or subjects with evidence of impaired liver/kidney function upon entry into the study. * Subjects with evidence of significant structural abnormalities of the gastrointestinal tract.
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 alone. | 12 weeks with a 6 month open label extension |
Outcome results
None listed