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

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

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.

Study Overview

• Status: Completed
• Conditions: Acute Pain Following a Total Abdominal Hysterectomy
• Intervention / Treatment: Drug: etoricoxib (MK0663) 120 mg; Drug: etoricoxib (MK0663) 90 mg; Drug: Comparator: Placebo

• Study Type: Interventional
• Enrollment (Actual): 430
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: etoricoxib (MK0663) 120 mg; 120 mg of etoricoxib (MK0663) for a total of 5 days; Other Names: Arcoxia
Experimental: Etoricoxib 90 mg; 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; 90 mg of etoricoxib (MK0663) for a total of 5 days
Placebo Comparator: Placebo; Placebo- 3 tablets once daily	Drug: Comparator: Placebo; Placebo tablets once daily on Days 1-5. Total treatment is 5 days.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Organon and Co

Publications and helpful links

General Publications

• Viscusi ER, Frenkl TL, Hartrick CT, Rawal N, Kehlet H, Papanicolaou D, Gammaitoni A, Ko AT, Morgan LM, Mehta A, Curtis SP, Peloso PM. Perioperative use of etoricoxib reduces pain and opioid side-effects after total abdominal hysterectomy: a double-blind, randomized, placebo-controlled phase III study. Curr Med Res Opin. 2012 Aug;28(8):1323-35. doi: 10.1185/03007995.2012.707121. Epub 2012 Jul 16.

Study record dates

Study Major Dates

• Study Start: October 1, 2008
• Primary Completion (Actual): July 1, 2010
• Study Completion (Actual): July 1, 2010

Study Registration Dates

• First Submitted: November 5, 2008
• First Submitted That Met QC Criteria: November 7, 2008
• First Posted (Estimate): November 11, 2008

Study Record Updates

• Last Update Posted (Actual): February 9, 2022
• Last Update Submitted That Met QC Criteria: February 7, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Acute Pain; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Cyclooxygenase 2 Inhibitors; Etoricoxib
• Other Study ID Numbers: 0663-097; 2008_578