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
| Verified date | February 2022 |
| Source | Organon and Co |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| 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 |
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Organon and Co |
| 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 |