Histerectomía Abdominal Abdominal Hysterectomy MedDRA version: 9.1 Level: LLT Classification code 10021151 Term: Hysterectomy
Conditions
Interventions
Trade Name: ARCOXIA 60 mg comprimidos recubiertos con película
Pharmaceutical Form: Tablet
INN or Proposed INN: ETORICOXIB
Other descriptive name: ETORI
Sponsors
Merck & Co., Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patient is scheduled to have a total abdominal hysterectomy using a transverse or Pfannenstiel incision under general anesthesia. 2) Except for the need of a total abdominal hysterectomy, 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 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
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 etoricoxib. 3) Patient has clinically significant abnormalities on prestudy clinical laboratory safety tests. As a guide, the following values would be considered exclusionary: WBC 1.5 x ULN, ALT > 1.5 x ULN. 4) Patient is having surgery for treatment of chronic pelvic inflammatory disease (PID). 5) Patient has unstable hypertension (systolic>160 mm Hg or diastolic > 90 mm Hg) at Visit 1. Investigators are encouraged to maximize blood pressure control according to local guidelines. Note: Local product labeling should be followed. In countries where the use of etoricoxib is contraindicated in patients with blood pressure values that are persistently elevated above 140/90 mm Hg, this definition should be used. 6) Patient has class II-IV congestive heart failure. 7) 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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine the analgesic effect of etoricoxib (120 mg, 90 mg), administered once daily, compared with placebo, as measured by Pain Intensity at Rest (0 to 10 numeric rating scale [NRS]), averaged over Days 1 to 3 postoperatively;Secondary Objective: 1) To determine the analgesic effect of etoricoxib (120 mg, 90 mg), administered once daily, compared with placebo as measured by a reduction in the average total daily dose of morphine (or morphine equivalent) used over Days 1 to 3 postoperatively. 2) To determine the analgesic effect of etoricoxib (120 mg, 90 mg), administered daily, compared with placebo, as measured by Elicited Pain upon Sitting averaged over Days 1 to 3 postoperatively.;Primary end point(s): 1) The average difference in pain intensity (measured at rest) averaged over Days 1 to 3 in patients treated with etoricoxib (120 mg, 90 mg) and placebo. 2) The average difference in daily dose of morphine over Days 1 to 3 in patients treated with etoricoxib (120 mg, 90 mg) and placebo. 3) The average difference in pain intensity (elicited by the patient sitting from a supine position) averaged over Days 1 to 3 in patients treated with etoricoxib (120 mg, 90 mg) and placebo. | — |
Countries
Austria, Estonia, Hungary, Ireland, Spain, Sweden
Outcome results
None listed