Study of MK-0663/Etoricoxib in Postorthopedic Knee Replacement Surgery Pain (MK-0663-098)
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
Outcome
Met primary endpoint
registry analysis (superiority test); Etoricoxib 120 mg vs Placebo; p = 0.018; Difference in Least Squares Mean -0.49 (95% CI -0.89 to -0.08) NCT00820027 ↗
registry analysis (superiority test); Etoricoxib 90 mg vs Placebo; p = 0.009; Difference in Least Squares Mean -0.54 (95% CI -0.95 to -0.14) NCT00820027 ↗
registry analysis (superiority test); Etoricoxib 120 mg vs Placebo; p <0.001; Between-Treatment Ratio 0.69 (95% CI 0.56 to 0.85) NCT00820027 ↗
registry analysis (superiority test); Etoricoxib 90 mg vs Placebo; p <0.001; Between-Treatment Ratio 0.66 (95% CI 0.54 to 0.82) NCT00820027 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| 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 | — |