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

NCT00820027 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 776

Last updated 2022-02-09

Study results available
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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

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

Sponsors & Collaborators

  • Organon and Co

    lead INDUSTRY

Principal Investigators

  • Medical Director · Merck Sharp & Dohme LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00820027 on ClinicalTrials.gov