Study of MK0663/Etoricoxib in Postorthopedic Knee Replacement Surgery Pain
Information source: Merck
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Postorthopedic Knee Replacement Surgery Pain
Intervention: Comparator: etoricoxib (MK0663) (Drug); Comparator: ibuprofen (Drug); Comparator: placebo (Drug)
Phase: Phase 3
Status: Recruiting
Sponsored by: Merck Official(s) and/or principal investigator(s):
Medical Monitor, Study Director, Affiliation: Merck
Overall contact:
Toll Free Number, Phone: 1-888-577-8839
Summary
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.
Clinical Details
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 design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: 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
Secondary outcome: Overall analgesic effect as measured by pain intensity difference at rest over days 1 through 3 compare to ibuprofen
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Toll Free Number, Phone: 1-888-577-8839
Merck Sharp & Dohme IDEA Inc., Praha 162 00, Czech Republic; Recruiting
Simona Martinkova, Phone: 420-233-010-213
Msd Sharp & Dohme Gmbh, Haar 85540, Germany; Recruiting
Thomas Lang, Phone: 49-89-4561-1536
MSD Magyarorszag Kft., Budapest 1123, Hungary; Recruiting
Geza Szoverffy, Phone: 36-1 888 5325
Merck Sharp & Dohme (I.A.) Corporation, Makati City 1229, Philippines; Recruiting
Cesar "Butch" Recto II, Phone: 632-885-0700
Merck Sharp & Dohme (Singapore), Singapore 199555, Singapore; Recruiting
Nazrin Azli, Phone: 603-77181748
Call for Information, Pasadena, California 91105, United States; Recruiting
Call for Information, Los Angeles, California 90095-7115, United States; Recruiting
Call for Information, Laguna Hills, California 92653, United States; Recruiting
Merck Sharp & Dohme IDEA, Inc., Tallinn, Eesti 11415, Estonia; Recruiting
Andrius Bacevicius, Phone: 370-5-2780-243
Call for Information, Chicago, Illinois 60612, United States; Recruiting
Merck Sharp & Dohme Ilaclari Ltd. Sti, Istinye, Istanbul 34460, Turkey; Recruiting
Meltem Telaferli, Phone: 90 212 365 5354
UAB Merck Sharp & Dohme, Vilnius, Lietuva, Lithuania; Recruiting
Andrius Bacevicius, Phone: 3705 2 780 243
Call for Information, Morristown, New Jersey 07960, United States; Recruiting
Call for Information, Pittsburgh, Pennsylvania 15232, United States; Recruiting
Call for Information, Pittsburgh, Pennsylvania 15215, United States; Recruiting
Call for Information, Philadelphia, Pennsylvania 19107-5092, United States; Recruiting
Call for Information, Altoona, Pennsylvania 16602, United States; Recruiting
Call for Information, Houston, Texas 77054, United States; Recruiting
Call for Information, Houston, Texas 77024, United States; Recruiting
Additional Information
Starting date: December 2008
Ending date: August 2010
Last updated: October 16, 2009
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