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

Phase 3

Completed

• Conditions: Acute Pain Following a Total Abdominal Hysterectomy
• Interventions: Drug: etoricoxib (MK0663) 120 mg; Drug: etoricoxib (MK0663) 90 mg

• Registration Number: NCT00788710
• Lead Sponsor: Organon and Co

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-10
• Study First Submitted: 2008-11-05
• Study First Submitted QC: 2008-11-07
• Study First Posted: 2008-11-11
• Primary Completion: 2010-07
• Study Completion: 2010-07
• Results First Submitted: 2011-06-22
• Results First Submitted QC: 2011-06-22
• Results First Posted: 2011-07-22
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-07
• Last Update Posted: 2022-02-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 430

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Etoricoxib 120 mg	etoricoxib (MK0663) 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.
Etoricoxib 90 mg	etoricoxib (MK0663) 90 mg	etoricoxib (MK0663) 90 mg tablet and 2 placebo tablets once daily on Days 1-5. Total treatment is 5 days.

Primary Outcome Measures

Name	Time	Method
Average Pain Intensity at Rest Over Days 1 to 3	3 Days	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.

Secondary Outcome Measures

Name	Time	Method
Average Elicited Pain Upon Sitting Over Days 1 to 3	3 days	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.
Average Total Daily Dose of Morphine Over Days 1 to 3	3 days