A Randomised, Double Blind, Placebo and Active Controlled, Double Dummy,Parallel Group Study to Determine the Safety and Efficacy of Oxycodone/Naloxone Prolonged Release Tablets in Subjects With Moderate to Severe, Chronic Nonmalignant Pain
- Conditions
- Subjects With Moderate to Severe, Chronic Nonmalignant Pain
- Interventions
- Drug: placebo oxycodone / naloxone
- Registration Number
- NCT01971632
- Lead Sponsor
- Mundipharma Research GmbH & Co KG
- Brief Summary
The primary objective was to demonstrate the superiority of OXN over placebo over time from the initial dose of study medication to multiple pain events (inadequate analgesia) during the double blind phase.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 463
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Oxycodone/Naloxone Oxycodone & naloxone combination, prolonged release - Placebo oxycodone/naloxone placebo oxycodone / naloxone -
- Primary Outcome Measures
Name Time Method Efficacy of Analgesia up to 12 weeks Primary Objective is To demonstrate the superiority of OXN over placebo on the time from the initial dose of study medication to multiple (ie, recurring) pain events (inadequate analgesia) during the Double-blind Phase.
- Secondary Outcome Measures
Name Time Method Quality of sleep assessment up to 12 weeks Secondary To compare sleep quality during treatment with OXN compared with placebo and OXY compared with placebo as measured by the sleep interference item of the modified Brief Pain Inventory Short Form (modified BPI-SF)4.
The amount of rescue medication taken up to 12 weeks Secondary to compare the total amount of rescue medication used per day (24 hours) by subjects receiving OXN, OXY, and placebo.