drugset / Trial / NCT00820027

Study of MK-0663/Etoricoxib in Postorthopedic Knee Replacement Surgery Pain (MK-0663-098)

NCT00820027

Phase 3 Completed 776 enrolled Organon and Co
RandomizedParallel-groupDouble-blindTreatment

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.

Timeline

Start
2008-12-15
Primary completion
2010-12-13
Completion
2010-12-14

Drugs

EvaluationDrugModalityDoseRoute
Subject Etoricoxib Small molecule 90 mg
Subject Etoricoxib Small molecule 120 mg
Comparator Ibuprofen Small molecule 600 mg
Background Morphine Other / unclassified Intravenous
Background Oxycodone Other / unclassified 5 mg

Indications