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

Acute Pain Following a Total Abdominal Hysterectomy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00788710
• Other study ID #: 0663-097
• Secondary ID: 2008_578
• Status: Completed
• Phase: Phase 3
• Start date: October 2008
• Est. completion date: July 2010

Study information

• Verified date: February 2022
• Source: Organon and Co
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 430
• Est. completion date: July 2010
• Est. primary completion date: July 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Pain
• Acute Pain Following a Total Abdominal Hysterectomy

Intervention

Drug:
• etoricoxib (MK0663) 120 mg
120 mg of etoricoxib (MK0663) for a total of 5 days
• Comparator: Placebo
Placebo tablets once daily on Days 1-5. Total treatment is 5 days.
• etoricoxib (MK0663) 90 mg
90 mg of etoricoxib (MK0663) for a total of 5 days

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Organon and Co

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Average Total Daily Dose of Morphine Over Days 1 to 3		3 days
Secondary	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