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

Organon

Status and phase: Completed; Phase 3

Conditions: Acute Pain Following a Total Abdominal Hysterectomy

Treatments: Drug: etoricoxib (MK0663) 90 mg; Drug: Comparator: Placebo; Drug: etoricoxib (MK0663) 120 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT00788710

0663-097

2008_578

Details and patient eligibility

About

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.

Enrollment: 430 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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430 participants in 3 patient groups, including a placebo group

Etoricoxib 120 mg

Experimental group

Description:

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

Treatment:

Drug: etoricoxib (MK0663) 120 mg

Etoricoxib 90 mg

Experimental group

Description:

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

Treatment:

Drug: etoricoxib (MK0663) 90 mg

Placebo

Placebo Comparator group

Description:

Placebo- 3 tablets once daily

Treatment:

Drug: Comparator: Placebo