?Ensayo multicéntrico doble ciego controlado con placebo para estudiar la eficacia y la tolerabilidad de MK-0663/etoricoxib en el tratamiento del dolor después de histerectomía abdominal? A Double-Blind, Placebo-Controlled, Multicenter Trial to Study the Efficacy and Tolerability of MK-0663/Etoricoxib in the Treatment of Pain after Abdominal Hysterectomy - Phase III Study of Etoricoxib in Post-Abdominal Hysterectomy Surgery Pai
- Conditions
- Histerectomía Abdominal Abdominal HysterectomyMedDRA version: 9.1 Level: LLT Classification code 10021151 Term: Hysterectomy
- Registration Number
- EUCTR2008-004867-21-ES
- Lead Sponsor
- Merck & Co., Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 396
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
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 <3500/?g, platelets <10000/ ?g, AST>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).
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method