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Study of MK0663/Etoricoxib in Postorthopedic Knee Replacement Surgery Pain (MK-0663-098 AM3)

This study has been completed.
Sponsor:
Information provided by:
Merck
ClinicalTrials.gov Identifier:
NCT00820027
First received: January 7, 2009
Last updated: March 25, 2011
Last verified: March 2011
History of Changes
  Purpose

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 Intervention 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 Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:

MedlinePlus related topics: Knee Replacement
U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:
  • Average Pain Intensity Difference at Rest (etoricoxib 120 mg/ 90 mg to placebo) [ Time Frame: Day 1 to Day 3 ] [ Designated as safety issue: No ]
  • Average Total Daily Dose of Morphine (etoricoxib 120 mg/90 mg to placebo) [ Time Frame: Day 1 to Day 3 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Average Pain Intensity Difference at Rest (etoricoxib 120 mg/ 90 mg to ibuprofen 1800 mg) [ Time Frame: Day 1 to Day 3 ] [ Designated as safety issue: No ]
  • Average total Daily Dose of Morphine (etoricoxib 120 mg/90 mg to ibuprofen 1800 mg) [ Time Frame: Day 1 to Day 3 ] [ Designated as safety issue: No ]

Enrollment: 776
Study Start Date: December 2008
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Vice President, Late Stage Development Group Leader, Merck Sharp & Dohme Corp
ClinicalTrials.gov Identifier: NCT00820027     History of Changes
Other Study ID Numbers: MK-0663-098, 2009_502
Study First Received: January 7, 2009
Last Updated: March 25, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
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
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Central Nervous System Agents
Cyclooxygenase 2 Inhibitors

ClinicalTrials.gov processed this record on May 16, 2013