At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 247 enrolled
Drug / intervention
Oxycodone/Naloxone +1 moredrug
Likely dose
Oxycodone/Naloxone 10 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 4 clinical trial evaluating Oxycodone/Naloxone and Codeine/Paracetamol for Osteoarthritis and Back Pain. Completed, enrolled 247 participants across 1 site.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOsteoarthritis, Back Pain
CountriesUnited Kingdom
Collaborators--
Timeline
Phase 4CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedNov 2008
Enrollment StartFeb 2009
Primary CompletionMar 2010
Study CompletionJun 2011
TodayJul 2026
First PostedNov 4, 2008
Enrollment StartFeb 1, 2009
Primary CompletionMar 1, 2010
Study CompletionJun 1, 2011
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 17.7 years ago
Interventions
Oxycodone/Naloxonedrug
5/2.5, 10/5 and 20/10 mg oxycodone/naloxone combination, 12 hourly
Codeine/Paracetamoldrug
15/500 and 30/500 mg codeine/paracetamol tablets, 2 tablets 6 hourly