Pain after total knee replacement MedDRA version: 9.1 Level: LLT Classification code 10023477 Term: Knee pain
Conditions
Interventions
Trade Name: ARCOXIA
Product Name: ARCOXIA 60 mg tablets
Pharmaceutical Form: Tablet
INN or Proposed INN: etoricoxib
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number:
Sponsors
Merck & Co., Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
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. 5) Patient is able to tolerate clear liquid and has pain intensity =5 (0-to-10 point NRS) postoperatively prior to 6 PM on the day of surgery. 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
Exclusion criteria: 1) Patient is considered morbidly obese. Morbidly obese is defined as the patient´s weight interferes with the performance of usual and typical vocational/avocational activities and/or is a serious independent health risk, likely to result in medical complications with the next year. 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 1.5 x ULN, ALT > 1.5 x ULN. 4) Patient has in the opinion of the investigator, inadequately controlled hypertension at Visit V1. 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). 7) Patient has used any of the following therapies which could interfere with the evaluation of efficacy, safety, or tolerability: - Postoperative use of any hypnotic agents and tranquilizers (such as lorazepam and diazepam), sedatives (such as phenobarbitol), or muscle relaxants (such as cyclobenzaprine and carisoprodol) are not permitted. - Post operatively, only 5HT3 antagonists (such as ondansetron, granisitron, dolasetron, or tropisetron) or benzamides (such as metoclopramide or alizapride) are permitted for the prevention and treatment of nausea and emesis on Day 1. The use of 5HT3 antagonists or benzamides is permitted only for the treatment of nausea and emesis on Days 2 through 7.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 1. To compare pain intensity measured at rest over Days 1 through 3 in patients treated with etoricoxib (120 mg, 90 mg) or placebo in the treatment of pain following total knee replacement orthopaedic surgery. 2. to compare the total daily dose of morphine used on Days 1 through 3 in patients treated with etoricoxib (120 mg, 90 mg) or placebo in the treatment of pain following total knee replacement orthopaedic surgery.;Secondary Objective: To compare the pain intensity difference measured at rest over days 1 through 3 in patients treated with etoricoxib (120 mg, 90 mg) or ibuprofen 1800 mg (administered as 600 mg every 8 hour) for the treatment of pain following total knee replacement orthopaedic surgery.;Primary end point(s): 1) The average pain intensity (measured at rest) difference over Days 1 through 3 in patients treated with etoricoxib (120 mg, 90 mg) and placebo 2) The average daily dose of morphine over Days 1 through 3 in patients treated with etoricoxib (120 mg, 90 mg) and placebo. | — |
Countries
Bulgaria, Czech Republic, Estonia, Germany, Hungary, Lithuania, Slovenia
Outcome results
None listed