Acute Pain Following a Total Abdominal Hysterectomy
Conditions
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.
Interventions
DRUGetoricoxib (MK0663) 120 mg
120 mg of etoricoxib (MK0663) for a total of 5 days
DRUGComparator: Placebo
Placebo tablets once daily on Days 1-5. Total treatment is 5 days.
DRUGetoricoxib (MK0663) 90 mg
90 mg of etoricoxib (MK0663) for a total of 5 days
Sponsors
Organon and Co
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Average Pain Intensity at Rest Over Days 1 to 3 | 3 Days | 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
| Measure | Time frame | Description |
|---|---|---|
| Average Total Daily Dose of Morphine Over Days 1 to 3 | 3 days | — |
| Average Elicited Pain Upon Sitting Over Days 1 to 3 | 3 days | 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. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 144 |
| Etoricoxib 90 mg Etoricoxib (MK0663) 90 mg tablet and 2 placebo tablets once daily on Days 1-5. Total treatment is 5 days. | 142 |
| Placebo Placebo - 3 tablets once daily on Days 1-5. Total treatment is 5 days. | 144 |
| Total | 430 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 1 | 3 | 4 |
| Overall Study | Lack of Efficacy | 0 | 0 | 1 |
| Overall Study | Lost to Follow-up | 0 | 1 | 0 |
| Overall Study | Physician Decision | 2 | 1 | 0 |
| Overall Study | Protocol Violation | 0 | 1 | 1 |
| Overall Study | Withdrawal by Subject | 2 | 2 | 0 |
Baseline characteristics
| Characteristic | Etoricoxib 120 mg | Etoricoxib 90 mg | Placebo | Total |
|---|---|---|---|---|
| Age, Continuous | 46.3 years STANDARD_DEVIATION 6.9 | 47.0 years STANDARD_DEVIATION 7.2 | 45.7 years STANDARD_DEVIATION 7 | 46.3 years STANDARD_DEVIATION 7 |
| Sex: Female, Male Female | 144 Participants | 142 Participants | 144 Participants | 430 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 60 / 144 | 51 / 142 | 65 / 144 |
| serious Total, serious adverse events | 5 / 144 | 5 / 142 | 10 / 144 |
Outcome results
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.
Time frame: 3 Days
Population: Full analysis set population
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Etoricoxib 120 mg | Average Pain Intensity at Rest Over Days 1 to 3 | 2.40 Score on a scale | Standard Error 0.15 |
| Etoricoxib 90 mg | Average Pain Intensity at Rest Over Days 1 to 3 | 2.46 Score on a scale | Standard Error 0.15 |
| Placebo | Average Pain Intensity at Rest Over Days 1 to 3 | 3.26 Score on a scale | Standard Error 0.15 |
p-value: <0.001ANOVA
p-value: <0.001ANOVA
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.
Time frame: 3 days
Population: Full analysis set population
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Etoricoxib 120 mg | Average Elicited Pain Upon Sitting Over Days 1 to 3 | 3.58 Score on a scale | Standard Error 0.17 |
| Etoricoxib 90 mg | Average Elicited Pain Upon Sitting Over Days 1 to 3 | 3.80 Score on a scale | Standard Error 0.17 |
| Placebo | Average Elicited Pain Upon Sitting Over Days 1 to 3 | 4.71 Score on a scale | Standard Error 0.17 |
p-value: <0.001ANOVA
p-value: <0.001ANOVA
Secondary
Average Total Daily Dose of Morphine Over Days 1 to 3
Time frame: 3 days
Population: Full analysis set population
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Etoricoxib 120 mg | Average Total Daily Dose of Morphine Over Days 1 to 3 | 5.37 milligrams (mg) | Standard Error 0.08 |
| Etoricoxib 90 mg | Average Total Daily Dose of Morphine Over Days 1 to 3 | 5.46 milligrams (mg) | Standard Error 0.08 |
| Placebo | Average Total Daily Dose of Morphine Over Days 1 to 3 | 7.75 milligrams (mg) | Standard Error 0.08 |
p-value: <0.001ANOVA
p-value: <0.001ANOVA