Study of MK0663/Etoricoxib in Postorthopedic Knee Replacement Surgery Pain - Full Text View

Sponsored by:	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 other pain medications in the treatment of postoperative pain.

Condition	Intervention	Phase
Postorthopedic Knee Replacement Surgery Pain	Drug: Comparator: etoricoxib (MK0663) Drug: Comparator: ibuprofen Drug: Comparator: placebo	Phase III

MedlinePlus related topics: Knee Replacement Surgery

Drug Information available for: Ibuprofen Dexibuprofen Etoricoxib

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
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

Further study details as provided by Merck:

Primary Outcome Measures:

Overall analgesic effect as measured by pain intensity difference at rest over days 1 through 3 compare to placebo; Use of average total daily dose of morphine over days 1 through 3 compare to placebo; Safety and tolerability of etoricoxib over 7 days [ Time Frame: Days 1-3 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Overall analgesic effect as measured by pain intensity difference at rest over days 1 through 3 compare to ibuprofen [ Time Frame: Days 1-3 ] [ Designated as safety issue: No ]

Estimated Enrollment:	713
Study Start Date:	January 2009
Estimated Study Completion Date:	December 2009
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Etoricoxib	Drug: Comparator: etoricoxib (MK0663) Patients will receive either 120 mg or 90 mg etoricoxib tablets once daily and placebo to ibuprofen three times daily for 1 week following knee replacement surgery.
2: Experimental Etoricoxib	Drug: Comparator: etoricoxib (MK0663) Patients will receive either 120 mg or 90 mg etoricoxib tablets once daily and placebo to ibuprofen three times daily for 1 week following knee replacement surgery.
3: Active Comparator Ibuprofen	Drug: Comparator: ibuprofen Patients will receive 600 mg ibuprofen tablets three times daily and placebo to etoricoxib 60 mg and 90 mg once daily for 1 week following knee replacement surgery.
4: Placebo Comparator Placebo	Drug: Comparator: placebo Patients will receive placebo tablets three times daily for 1 week following knee replacement surgery.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients is 18 years of age or older
Patient is in generally good health and is scheduled to have a total knee replacement

Exclusion Criteria:

Patient is allergic, intolerant to, or has a history of a significant clinical or laboratory adverse experience associated with etoricoxib or other COX-2 inhibitors/NSAIDs, ibuprofen, morphine, or oxycodone, or has hypersensitivity to aspirin, or other NSAIDs
Patient has uncontrolled hypertension
Patient 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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00820027

Contacts

Contact: Toll Free Number

1-888-577-8839

Locations

United States, California
Call for Information	Recruiting
Pasadena, California, United States, 91105
Call for Information	Recruiting
Laguna Hills, California, United States, 92653
United States, New Jersey
Call for Information	Recruiting
Morristown, New Jersey, United States, 07960
Norway
MSD (Norge) AS	Recruiting
Drammen, Norway, 3011
Contact: Gunnar Saeter 47 32 20 7460
Singapore
Merck Sharp & Dohme (Singapore)	Recruiting
Singapore, Singapore, 199555
Contact: Nazrin Azli 603-77181748

Sponsors and Collaborators

Merck

Investigators

Study Director:

Medical Monitor

Merck

More Information

No publications provided

Responsible Party:	Merck & Co., Inc. ( Executive Vice President, Clinical and Quantitative Sciences )
Study ID Numbers:	2009_502, MK0663-098
Study First Received:	January 7, 2009
Last Updated:	April 8, 2009
ClinicalTrials.gov Identifier:	NCT00820027 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Anti-Inflammatory Agents
Ibuprofen
Analgesics, Non-Narcotic
Cyclooxygenase Inhibitors
Etoricoxib

Anti-Inflammatory Agents, Non-Steroidal
Pain
Peripheral Nervous System Agents
Analgesics
Antirheumatic Agents

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Ibuprofen
Molecular Mechanisms of Pharmacological Action
Etoricoxib
Physiological Effects of Drugs
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Pharmacologic Actions

Analgesics, Non-Narcotic
Sensory System Agents
Therapeutic Uses
Anti-Inflammatory Agents, Non-Steroidal
Analgesics
Peripheral Nervous System Agents
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on May 06, 2009