drugset / Trial / NCT00784810
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
RandomizedParallel-groupQuadruple-blindTreatment
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.
Timeline
- Start
- 2009-02
- Primary completion
- 2010-03
- Completion
- 2011-06
Outcome
Met primary endpoint
registry analysis (non-inferiority or equivalence test); Oxycodone/Naloxone Tablets (OXN) vs Codeine/Paracetamol Tablets; p = 0.002; Mean Difference (Net) 0.44; Mixed Models Analysis NCT00784810 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Acetaminophen | Small molecule | 500 mg | — |
| Comparator | Codeine | Small molecule | 15 mg | — |
| Comparator | Codeine | Small molecule | 30 mg | — |
| Subject | Naloxone | Small molecule | 2.5 mg | — |
| Subject | Naloxone | Small molecule | 5 mg | — |
| Subject | Naloxone | Small molecule | 10 mg | — |
| Subject | Oxycodone | Other / unclassified | 5 mg | — |
| Subject | Oxycodone | Other / unclassified | 10 mg | — |
| Subject | Oxycodone | Other / unclassified | 20 mg | — |