drugset / Trial / NCT01083485

OXN PR Compared to OXY PR in Subjects With Postoperative Pain After Knee Arthroplasty

NCT01083485 ↗

Phase 4 Completed 137 enrolled Mundipharma Oy
RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start
2010-03
Primary completion
2010-10
Completion
2010-11

Outcome

Met primary endpoint

registry Mean Difference (Final Values) -0.1 (95% CI -0.5 to 0.3); ANCOVA; note: A P value was not part of the analysis plan. NCT01083485 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Naloxone Small molecule 5 mg —
Subject Naloxone Small molecule 10 mg —
Comparator Oxycodone Other / unclassified 10 mg —
Comparator Oxycodone Other / unclassified 20 mg —

Indications

No indication recorded.