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

Sponsor:	Merck
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00820027

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 III

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

Drug Information available for: Ibuprofen Etoricoxib

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 February 09, 2012