NCT00820027

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 776 (actual)
• Sponsor: Organon and Co · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Pain, Postoperative

Interventions

Type	Name	Description
DRUG	Etoricoxib 90 mg	One 90 mg tablet once daily
DRUG	Etoricoxib 120 mg	Two 60 mg tablets once daily
DRUG	Ibuprofen 600 mg	One tablet three times daily
DRUG	Matching Placebo for Etoricoxib 120 mg	Two tablets once daily
DRUG	Matching Placebo for Etoricoxib 90 mg	One tablet once daily
DRUG	Matching Placebo for Ibuprofen	One tablet three times daily
DRUG	Morphine	As needed via patient-controlled analgesia (PCA) device or as a bolus intravenous injection
DRUG	Oxycodone	5 mg as needed

Timeline

• Start date: 2008-12-15
• Primary completion: 2010-12-13
• Completion: 2010-12-14
• First posted: 2009-01-09
• Last updated: 2022-02-09
• Results posted: 2020-04-07