A Study of MK0663/Etoricoxib for Post-Abdominal Hysterectomy Surgery Pain (0663-097)(COMPLETED)

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the efficacy and safety of etoricoxib compared to placebo in the treatment of postoperative pain associated with total abdominal hysterectomy.

Official Title
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A Double-Blind, Placebo-Controlled, Multicenter Trial to Study the Efficacy and Tolerability of MK0663/Etoricoxib in the Treatment of Pain After Abdominal Hysterectomy

Conditions
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Acute Pain Following a Total Abdominal Hysterectomy

Intervention / Treatment
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* Drug: etoricoxib (MK0663) 120 mg
* Drug: Comparator: Placebo
* Drug: etoricoxib (MK0663) 90 mg


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients 18 years or older in generally good health who are scheduled to have a total hysterectomy and who are willing to limit alcohol consumption Exclusion Criteria: Patient is allergic to the study drug, other cyclooxygenase-2 (COX-2) inhibitors/nonsteroidal anti-inflammatory drugs (NSAIDS), ibuprofen, morphine, or oxycodone or has hypersensitivity to aspirin or other NSAIDS Patient has uncontrolled high blood pressure Patient has a history of drug and/or alcohol abuse within the last 5 years Patient has taken part in another investigational study within 4 weeks of the start of study Patient is breast-feeding Patient has an active ulcer or inflammatory bowel disease

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Etoricoxib 120 mg<br>etoricoxib (MK0663) 120 mg (2 60 mg tablets) and 1 placebo tablet once daily on Days 1-5. Total treatment is 5 days. | Drug: etoricoxib (MK0663) 120 mg<br>* 120 mg of etoricoxib (MK0663) for a total of 5 days<br>* Other names: Arcoxia;|
| Experimental: Etoricoxib 90 mg<br>etoricoxib (MK0663) 90 mg tablet and 2 placebo tablets once daily on Days 1-5. Total treatment is 5 days. | Drug: etoricoxib (MK0663) 90 mg<br>* 90 mg of etoricoxib (MK0663) for a total of 5 days<br>|
| Placebo Comparator: Placebo<br>Placebo- 3 tablets once daily | Drug: Comparator: Placebo<br>* Placebo tablets once daily on Days 1-5. Total treatment is 5 days.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Average Pain Intensity at Rest Over Days 1 to 3 | Pain intensity at rest was measured on a 0- to 10-point scale: 0=no pain, to 10=pain as bad as you can imagine. | 3 Days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Average Total Daily Dose of Morphine Over Days 1 to 3 |  | 3 days | 
| Average Elicited Pain Upon Sitting Over Days 1 to 3 | Elicited pain upon sitting was measured on a 0- to 10-point scale: 0=no pain, to 10=pain as bad as you can imagine. | 3 days |