At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase III Randomized, Double-Blind, Placebo- and Active-Comparator-Controlled, Multiple-Dose, Clinical Trial to Study the Safety and Efficacy of MK0663/Etoricoxib and Ibuprofen in the Treatment of Postorthopedic Knee Replacement Surgery Pain
In Brief
A Phase 3 clinical trial evaluating Etoricoxib 90 mg, Etoricoxib 120 mg, and 6 other interventions for Pain, Postoperative. Completed, enrolled 776 participants.
Detailed Summary
The purpose of this study was to evaluate the efficacy and safety of Etoricoxib compared to placebo and ibuprofen in the treatment of postoperative pain associated with unilateral total knee replacement surgery. The hypotheses for this study were that the average pain intensity difference (at rest) in participants treated with Etoricoxib (120 mg, 90 mg) is superior to placebo, the average total daily dose of morphine in participants treated with Etoricoxib (120 mg, 90 mg) is less than in participants treated with placebo, and that Etoricoxib (120 mg, 90 mg) will be generally safe and well tolerated by participants treated for pain following total knee replacement orthopedic surgery.
Study Details
Timeline
Interventions
One 90 mg tablet once daily
Two 60 mg tablets once daily
One tablet three times daily
Two tablets once daily
One tablet once daily
One tablet three times daily
As needed via patient-controlled analgesia (PCA) device or as a bolus intravenous injection
5 mg as needed