Phase 3
Completed N=776
Study of MK-0663/Etoricoxib in Postorthopedic Knee Replacement Surgery Pain (MK-0663-098)
Pain, Postoperative
Source: ClinicalTrials.gov NCT00820027 ↗
Enrolled (actual)
776
Serious AEs
2.3%
Results posted
Apr 2020
Primary outcomePrimary: Average Change From Baseline for Pain Intensity at Rest Over Days 1 to 3 (Etoricoxib vs. Placebo) — -3.93; -3.87; -3.39 Score on a scale — p=0.018
◆ Published Evidence
Established
36citations · ~3 / year
Evaluation of etoricoxib in patients undergoing total knee replacement surgery in a double-blind, randomized controlled trial.
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.
Linked Publications
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Evaluation of etoricoxib in patients undergoing total knee replacement surgery in a double-blind, randomized controlled trial.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Average Change From Baseline for Pain Intensity at Rest Over Days 1 to 3 (Etoricoxib vs. Placebo) |
-3.93; -3.87; -3.39 | 0.018 sig |
| PRIMARY Average Total Daily Dose of Postoperative Morphine Over Days 1 to 3 (Etoricoxib vs. Placebo) |
8.87; 9.25; 13.40 | <0.001 sig |
| PRIMARY Percentage of Participants With at Least One Adverse Event of Congestive Heart Failure, Pulmonary Edema, or Cardiac Failure |
0.5; 0.0; 0.0; 0.0 | 0.506 |
| PRIMARY Percentage of Participants With at Least One Edema-Related AE |
0.9; 1.7; 1.8; 4.1 | 0.054 |
| PRIMARY Percentage of Participants With at Least One Hypertension-Related AE |
3.6; 1.3; 3.1; 3.1 | 0.806 |
| PRIMARY Percentage of Participants With at Least One Opioid-Related AE |
34.7; 36.5; 36.3; 41.8 | 0.365 |
| PRIMARY Percentage of Participants Who Discontinued Study Drug Due to an AE |
6.3; 3.5; 4.5; 5.1 | — |
| SECONDARY Average Change From Baseline for Pain Intensity at Rest Over Days 1 to 3 (Etoricoxib vs. Ibuprofen) |
-3.93; -3.87; -3.83 | — |
| SECONDARY Average Total Daily Dose of Postoperative Morphine Over Days 1 to 3 (Etoricoxib vs. Ibuprofen) |
8.87; 9.25; 8.82 | — |
Eligibility Criteria
Inclusion Criteria
- Is in generally good health and is scheduled to have a total knee replacement
Exclusion Criteria
- Is allergic, intolerant to, or has a history of a significant clinical or laboratory adverse experience associated with etoricoxib or other cyclooxygenase-2 (COX-2) inhibitors/non-steroidal anti-inflammatory drugs (NSAIDs), ibuprofen, morphine, or oxycodone, or has hypersensitivity to aspirin, or other NSAIDs
- Has uncontrolled hypertension
- Is currently a user of any illicit drugs, or has a history of drug or alcohol abuse within the past 5 years
Data sourced from ClinicalTrials.gov (NCT00820027) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.