A Study to Compare Oxycodone/Naloxone Prolonged Release Against Codeine/Paracetamol in the Treatment of Moderate to Severe Chronic Low Back Pain or Pain Due to Osteoarthritis
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||A Double-blind, Double-dummy, Parallel Group, Randomised Study to Compare the Efficacy & Tolerability of Oxycodone/Naloxone Prolonged Release (OXN PR) & Codeine/Paracetamol in the Treatment of Moderate to Severe Chronic Low Back Pain or Pain Due to Osteoarthritis|
- Average Daily Pain Score Box Scale-11 (BS-11) Recorded at Week 12 (Average Pain Over Last 24 Hours) [ Time Frame: Average daily pain over last 24 hours (at Week 12) ] [ Designated as safety issue: No ]The primary objective was to demonstrate non inferiority of Oxycodone/Naloxone Prolonged Release (OXN PR) compared to codeine/paracetamol in moderate to severe pain as assessed by BS-11 average daily pain scores. The Box Scale-11 is a scale from 0 to 10 (i.e. 0, 1, 2...10), where the subject records their daily pain over the previous 24 hours, by circling the relevant box, where 0 = no pain and 10 = pain as bad as you can imagine. This value is the value recorded at week 12 (average pain over the last 24 hours)
- Number of Intakes of Rescue Medication (Ibuprofen) Between Visit 8 and Visit 9 for the 2 Groups. [ Time Frame: Between visit 8 and 9 ] [ Designated as safety issue: No ]To compare the number of intakes of rescue medication use (ibuprofen) for breakthrough pain between OXN (Oxycodone/Naloxone) and codeine/paracetamol groups. Ibuprofen tablets (400mg up to 3 times per day) were available as rescue medication. This was recorded by the subject in their diary whenever it was taken. The discrepancy in numbers of patients at this stage (between Visit 8 and Visit 9) is due to subject withdrawal during the study. The mean values presented are the "number of intakes of rescue medication" for this period (ie between Visit 8 and Visit 9).
|Study Start Date:||February 2009|
|Study Completion Date:||June 2011|
|Primary Completion Date:||March 2010 (Final data collection date for primary outcome measure)|
Experimental: Oxycodone/Naloxone Tablets
5/2.5, 10/5 and 20/10 mg oxycodone/naloxone combination, 12 hourly
Active Comparator: Codeine/Paracetamol Tablets
15/500 and 30/500 mg codeine/paracetamol tablets, 2 tablets 6 hourly
This is a randomised, double-blind, double-dummy, parallel group, 12-week study to assess the efficacy and tolerability of oxycodone/naloxone compared to codeine/paracetamol tablets in the treatment of moderate to severe chronic low back pain or moderate to severe pain due to OA of the hip and /or knee.
The screening period will be 3 - 7 days duration. If a subject meets all the screening criteria they may enter the Run-in Period.
During the screening period subjects will continue to take their pre-study pain medication.
The run-in period will be 7 - 14 days duration. During the run-in period subjects will continue to take their pre-study pain medication.
Visit 3 will occur at the end of the Run-in Period (7-14 days after Visit 2). To qualify for entry into the treatment period of the study, subjects must have uncontrolled pain as shown by average daily pain scores of >5 on 4 of the last 7 days of the run in period.
Eligible subjects will be randomised to either oxycodone/naloxone or codeine/paracetamol tablets. Subjects will receive double-blind study medication for up to 12 weeks.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00784810
|Coventry, United Kingdom, CV6 4DD|