E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Pain after Abdominal Hysterectomy |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10021151 |
E.1.2 | Term | Hysterectomy |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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 |
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E.2.2 | Secondary objectives of the trial |
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. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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.
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E.4 | Principal 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 <3500/μg, platelets <10000/ μg, 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).
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E.5 End points |
E.5.1 | 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. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | Yes |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 2 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 16 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |