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

NCT01083485 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 137

Last updated 2012-02-16

Study results available
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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.

Conditions

  • Post Operative Pain

Interventions

DRUG

Oxycodone/Naloxone PR 20/10mg or 10/5mg tablets

Oxycodone/Naloxone prolonged release 20/10mg or 10/5mg tabs twice a day (BID) for 2.5 days (total 5 dosages)or Oxycodone 20mg

DRUG

Oxycodone

Oxycodone 20mg or 10mg BID for 2.5 days (total 5 dosages)

Sponsors & Collaborators

  • Mundipharma Oy

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-03-31
Primary Completion
2010-10-31
Completion
2010-11-30

Countries

  • Finland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01083485 on ClinicalTrials.gov