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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

430 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-10-31

Study Completion Date

2010-07-31

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.

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Detailed Description

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Conditions

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Acute Pain Following a Total Abdominal Hysterectomy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Etoricoxib 90 mg

etoricoxib (MK0663) 90 mg tablet and 2 placebo tablets once daily on Days 1-5. Total treatment is 5 days.

Group Type EXPERIMENTAL

etoricoxib (MK0663) 90 mg

Intervention Type DRUG

90 mg of etoricoxib (MK0663) for a total of 5 days

Etoricoxib 120 mg

etoricoxib (MK0663) 120 mg (2 60 mg tablets) and 1 placebo tablet once daily on Days 1-5. Total treatment is 5 days.

Group Type EXPERIMENTAL

etoricoxib (MK0663) 120 mg

Intervention Type DRUG

120 mg of etoricoxib (MK0663) for a total of 5 days

Placebo

Placebo- 3 tablets once daily

Group Type PLACEBO_COMPARATOR

Comparator: Placebo

Intervention Type DRUG

Placebo tablets once daily on Days 1-5. Total treatment is 5 days.

Interventions

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etoricoxib (MK0663) 120 mg

120 mg of etoricoxib (MK0663) for a total of 5 days

Intervention Type DRUG

Comparator: Placebo

Placebo tablets once daily on Days 1-5. Total treatment is 5 days.

Intervention Type DRUG

etoricoxib (MK0663) 90 mg

90 mg of etoricoxib (MK0663) for a total of 5 days

Intervention Type DRUG

Other Intervention Names

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Arcoxia

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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No