Conditions: Osteoarthritis Back Pain
Keywords: Efficacy, tolerability, moderate/severe, oxycodone/naloxone codeine/paracetamol, chronic low back pain, osteoarthritis
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 247
Healthy volunteers: no

Brief summary:
The purpose of this study is to compare oxycodone/naloxone combination tablet and codeine/paracetamol tablets in the treatment of moderate to severe chronic low back pain or pain due to osteoarthritis.

Detailed description:
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.

Arms:
arm 1: Oxycodone/Naloxone combination arm 2: Codeine/Paracetamol combination

Interventions: intervention 1: Oxycodone/Naloxone intervention 2: Codeine/Paracetamol
Intervention descriptions: intervention 1: 5/2.5, 10/5 and 20/10 mg oxycodone/naloxone combination, 12 hourly intervention 2: 15/500 and 30/500 mg codeine/paracetamol tablets, 2 tablets 6 hourly

Protocol document: