A Phase III Randomized, Double-Blind, Placebo- and Active-Comparator-Controlled, Multiple-Dose, Clinical Trial to Study the Safety and Efficacy of MK-0663/Etoricoxib and Ibuprofen in the Treatment of Postorthopedic Knee Replacement Surgery Pain - Phase III study of etoricoxib in Postorthopedic Surgery pai

Conditions: Pain after total knee replacement
MedDRA version: 9.1Level: LLTClassification code 10023477Term: Knee pain

Registration Number: EUCTR2008-003379-28-DE

Lead Sponsor: Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., U.S.A.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 713

Inclusion Criteria

1) Patient is scheduled to have a total knee replacement surgery.
2) Except for the need of orthopaedic surgery, the patient is judged to be in otherwise general good health based on medical history, physical exam, and routine laboratory tests. Patient with chronic health conditions must be stable.
3) Patient is able to tolerate clear liquid and has pain intensity =5 (0-to-10-point Numerical Rating Scale) prior to 4 pm on the day of surgery.
4) Patient is willing to limit alcohol intake to =2 glasses of beer or wine or equivalent per day for the duration of the study and follow up period.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1) Patient is considered morbidly obese, defined as >40 kg/m2.
2) Patient has a history of a significant clinical or laboratory abnormality that in the opinion of the investigator contraindicates the use of NSAID such as ibuprofen or etoricoxib.
3) Patient has clinically significant abnormalities on prestudy clinical laboratory safety tests. As a guide, the following values would be considered clinically significant: WBC <3500/µg, platelets <10000/ µg, AST>1.5 x ULN, ALT > 1.5 x ULN.
4) Patient has uncontrolled hypertension (systolic >165 mmHg and diastolic >95 mmHg).
5) Patient has class II-IV congestive heart failure.
6) Patient has established ischemic heart disease, cerebrovascular disease, or peripheral vascular disease. In countries in which the use of COX-II inhibitors has not been contraindicated in patients with these conditions, patients can otherwise participate (with the exception of those patients who have undergone coronary artery bypass graft surgery, angioplasty, or had a cerebrovascular accident or transient ischemic attack within the past 6 months)