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

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ClinicalTrials.gov Identifier: NCT00820027
Recruitment Status : Completed
First Posted : January 9, 2009
Last Update Posted : May 27, 2015
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
The purpose of this study is 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.

Condition or disease Intervention/treatment Phase
Pain, Postoperative Drug: Etoricoxib 90 mg Drug: Etoricoxib 120 mg Drug: Ibuprofen 600 mg Drug: Matching Placebo for Etoricoxib 120 mg Drug: Matching Placebo for Etoricoxib 90 mg Drug: Matching Placebo for Ibuprofen Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 776 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : December 2008
Primary Completion Date : December 2010
Study Completion Date : December 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Knee Replacement
Drug Information available for: Ibuprofen
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Etoricoxib 90 mg Drug: Etoricoxib 90 mg
One 90 mg tablet once daily
Other Name: MK-0663
Drug: Matching Placebo for Etoricoxib 120 mg
Two tablets once daily
Drug: Matching Placebo for Ibuprofen
One tablet three times daily
Experimental: Etoricoxib 120 mg Drug: Etoricoxib 120 mg
Two 60 mg tablets once daily
Other Name: MK-0663
Drug: Matching Placebo for Etoricoxib 90 mg
One tablet once daily
Drug: Matching Placebo for Ibuprofen
One tablet three times daily
Active Comparator: Ibuprofen 1800 mg 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
Placebo Comparator: Placebo 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


Outcome Measures

Primary Outcome Measures :
  1. Average Pain Intensity Difference at Rest (etoricoxib 120 mg/ 90 mg to placebo) [ Time Frame: Day 1 to Day 3 ]
  2. Average Total Daily Dose of Morphine (etoricoxib 120 mg/90 mg to placebo) [ Time Frame: Day 1 to Day 3 ]

Secondary Outcome Measures :
  1. Average Pain Intensity Difference at Rest (etoricoxib 120 mg/ 90 mg to ibuprofen 1800 mg) [ Time Frame: Day 1 to Day 3 ]
  2. Average total Daily Dose of Morphine (etoricoxib 120 mg/90 mg to ibuprofen 1800 mg) [ Time Frame: Day 1 to Day 3 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00820027     History of Changes
Other Study ID Numbers: 0663-098
2009_502 ( Other Identifier: Merck Registration Number )
First Posted: January 9, 2009    Key Record Dates
Last Update Posted: May 27, 2015
Last Verified: May 2015

Additional relevant MeSH terms:
Pain, Postoperative
Pain
Neurologic Manifestations
Nervous System Diseases
Postoperative Complications
Pathologic Processes
Signs and Symptoms
Ibuprofen
Etoricoxib
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cyclooxygenase 2 Inhibitors