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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
137
Oxycodone/Naloxone prolonged release 20/10mg or 10/5mg tabs twice a day (BID) for 2.5 days (total 5 dosages)or Oxycodone 20mg
Oxycodone 20mg or 10mg BID for 2.5 days (total 5 dosages)
Central hospital of Pori
Pori, Finland
Mean of 4 NRS Scores for 24 Hour Pain Intensity at Rest, Shown as Absolute Change From Baseline (i.e. a Decrease From the Baseline Value)
The primary efficacy variable was the 24hr pain intensity score at rest, on a Numerical Rating Scale (NRS), with "0" = "no pain" and "10" = "worst possible pain". This was assessed 1 hour after dosing on Day 1 (evening only), Day 2(morning and evening) and Day 3 (morning only). The primary efficacy end point (absolute change from baseline) was analysed on the per protocol (PP) data. The mean of these scores is shown as a value that is a mean change (a decrease in pain score) from the baseline value.
Time frame: Mean of 24 hour pain intensity (absolute change from baseline)
Mean Dose (mg) of Rescue Analgesia for the Treatment Phase for Subjects Taking 20/10mg OXN PR Tablets or 20mg OXY PR Tablets
To compare the use of rescue analgesia for the 2 groups (OXN 20/10mg tablets and OXY 20mg tablets) during the double blind treatment phase. Rescue medication was given (OXY Immediate Release, 5mg capsules) if the subjects pain score on the (Numeric Rating Scale (NRS), 0 (no pain) to 10 (worst possible pain)), was greater than or equal to 4. The value presented is the mean dose over the double blind phase.
Time frame: Mean dose during the whole double blind treatment phase (2.5 days)
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