At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 137 enrolled
Drug / intervention
Oxycodone/Naloxone PR 20/10mg or 10/5mg tablets +1 moredrug
Likely dose
Oxycodone/Naloxone PR 20/10mg or 10/5mg tabletsfrom 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 Randomised, Double-blind, Parallel Group Multicentre Study to Demonstrate Non-inferiority of the Analgesic Efficacy of Oxycodone/Naloxone 10/5 or 20/10 mg Prolonged Release Tablets (OXN PR) BID Compared to Oxycodone 10 or 20 mg Prolonged Release Tablets (OXY PR) BID in Subjects With Postoperative Pain After Knee Arthroplasty
In Brief
A Phase 4 clinical trial evaluating Oxycodone/Naloxone PR 20/10mg or 10/5mg tablets and Oxycodone for Post Operative Pain. Completed, enrolled 137 participants across 1 site.
Detailed Summary
The purpose of this study is to demonstrate that treatment with OXN PR tablets is non inferior to treatment with OXY PR tablets in terms of analgesic efficacy in patients with postoperative pain after knee arthroplasty based on average pain intensity scores.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPost Operative Pain
CountriesFinland
Collaborators--
Timeline
Phase 4CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
Enrollment StartMar 2010
First PostedMar 2010
Primary CompletionOct 2010
Study CompletionNov 2010
TodayJul 2026
First PostedMar 9, 2010
Enrollment StartMar 1, 2010
Primary CompletionOct 1, 2010
Study CompletionNov 1, 2010
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 16.3 years ago
Interventions
Oxycodone/Naloxone PR 20/10mg or 10/5mg tabletsdrug
Oxycodone/Naloxone prolonged release 20/10mg or 10/5mg tabs twice a day (BID) for 2.5 days (total 5 dosages)or Oxycodone 20mg
Oxycodonedrug
Oxycodone 20mg or 10mg BID for 2.5 days (total 5 dosages)