Phase 3
N=430
A Study of MK0663/Etoricoxib for Post-Abdominal Hysterectomy Surgery Pain (0663-097)(COMPLETED)
Acute Pain Following a Total Abdominal Hysterectomy
Bottom Line
View on ClinicalTrials.gov: NCT00788710 ↗Enrolled (actual)
430
Serious AEs
4.7%
Results posted
Jul 2011
Primary outcome: Primary: Average Pain Intensity at Rest Over Days 1 to 3 — 2.40; 2.46; 3.26 Score on a scale — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- etoricoxib (MK0663) 120 mg (Drug); Comparator: Placebo (Drug); etoricoxib (MK0663) 90 mg (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Organon and Co
- Primary completion
- Jul 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Average Pain Intensity at Rest Over Days 1 to 3 |
2.40; 2.46; 3.26 | <0.001 sig |
| SECONDARY Average Total Daily Dose of Morphine Over Days 1 to 3 |
5.37; 5.46; 7.75 | <0.001 sig |
| SECONDARY Average Elicited Pain Upon Sitting Over Days 1 to 3 |
3.58; 3.80; 4.71 | <0.001 sig |
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.
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
Data sourced from ClinicalTrials.gov (NCT00788710). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.