Conditions: Post Operative Pain
Keywords: Oxycodone Naloxone Postoperative pain Arthroplasty Efficacy
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 137
Healthy volunteers: no

Brief 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.

Detailed description:

Arms:
arm 1: Oxycodone/Naloxone prolonged release 20/10mg or 10/5mg tabs twice a day (BID) for 2.5 days (total 5 dosages) arm 2: Oxycodone PR 20mg or 10mg (twice a day) BID for 2.5 days (total 5 dosages)

Interventions: intervention 1: Oxycodone/Naloxone PR 20/10mg or 10/5mg tablets intervention 2: Oxycodone
Intervention descriptions: intervention 1: Oxycodone/Naloxone prolonged release 20/10mg or 10/5mg tabs twice a day (BID) for 2.5 days (total 5 dosages)or Oxycodone 20mg intervention 2: Oxycodone 20mg or 10mg BID for 2.5 days (total 5 dosages)

Protocol document: