Back to resultsA Study of MK0663/Etoricoxib for Post-Abdominal Hysterectomy Surgery Pain (0663-097)(COMPLETED)
Primary Purpose
Acute Pain Following a Total Abdominal Hysterectomy
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
etoricoxib (MK0663) 120 mg
Comparator: Placebo
etoricoxib (MK0663) 90 mg
Sponsored by
About this trial
This is an interventional treatment trial for Acute Pain Following a Total Abdominal Hysterectomy
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
Etoricoxib 120 mg
Etoricoxib 90 mg
Placebo
Arm Description
etoricoxib (MK0663) 120 mg (2 60 mg tablets) and 1 placebo tablet once daily on Days 1-5. Total treatment is 5 days.
etoricoxib (MK0663) 90 mg tablet and 2 placebo tablets once daily on Days 1-5. Total treatment is 5 days.
Placebo- 3 tablets once daily
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Average Total Daily Dose of Morphine Over Days 1 to 3
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00788710
Brief Title
A Study of MK0663/Etoricoxib for Post-Abdominal Hysterectomy Surgery Pain (0663-097)(COMPLETED)
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
October 2008 (undefined)
Primary Completion Date
July 2010 (Actual)
Study Completion Date
July 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Organon and Co
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Pain Following a Total Abdominal Hysterectomy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
430 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Etoricoxib 120 mg
Arm Type
Experimental
Arm Description
etoricoxib (MK0663) 120 mg (2 60 mg tablets) and 1 placebo tablet once daily on Days 1-5. Total treatment is 5 days.
Arm Title
Etoricoxib 90 mg
Arm Type
Experimental
Arm Description
etoricoxib (MK0663) 90 mg tablet and 2 placebo tablets once daily on Days 1-5. Total treatment is 5 days.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo- 3 tablets once daily
Intervention Type
Drug
Intervention Name(s)
etoricoxib (MK0663) 120 mg
Other Intervention Name(s)
Arcoxia
Intervention Description
120 mg of etoricoxib (MK0663) for a total of 5 days
Intervention Type
Drug
Intervention Name(s)
Comparator: Placebo
Intervention Description
Placebo tablets once daily on Days 1-5. Total treatment is 5 days.
Intervention Type
Drug
Intervention Name(s)
etoricoxib (MK0663) 90 mg
Intervention Description
90 mg of etoricoxib (MK0663) for a total of 5 days
Primary Outcome Measure Information:
Title
Average Pain Intensity at Rest Over Days 1 to 3
Description
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.
Time Frame
3 Days
Secondary Outcome Measure Information:
Title
Average Total Daily Dose of Morphine Over Days 1 to 3
Time Frame
3 days
Title
Average Elicited Pain Upon Sitting Over Days 1 to 3
Description
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.
Time Frame
3 days
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Monitor
Organizational Affiliation
Merck Sharp & Dohme LLC
Official's Role
Study Director
12. IPD Sharing Statement
Citations:
PubMed Identifier
22738802
Citation
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.
Results Reference
derived
Learn more about this trial
A Study of MK0663/Etoricoxib for Post-Abdominal Hysterectomy Surgery Pain (0663-097)(COMPLETED)
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