Trial Outcomes & Findings for Study of MK-0663/Etoricoxib in Postorthopedic Knee Replacement Surgery Pain (MK-0663-098) (NCT NCT00820027)
NCT ID: NCT00820027
Last Updated: 2022-02-09
Results Overview
The pain intensity difference was measured at rest over Days 1 through 3 in patients treated with etoricoxib (120 mg, 90 mg) compared to placebo for the treatment of pain following total knee replacement orthopedic surgery. Pain intensity difference at rest was measured on a numerical rating scale (NRS) from 0 - 10 points (0=no pain, to 10=pain as bad as you can imagine). Comparison to placebo was conducted in a step-down manner (the 90-mg dose was evaluated only if the null hypotheses for co-primary endpoints \[Pain Intensity Difference (PID) and Morphine\] 120-mg doses were rejected). The primary analyses for change from baseline in average pain intensity at rest over Days 1 to 3 was performed using the longitudinal data analysis (LDA) method with the terms for baseline pain intensity (moderate or severe), type of anesthesia (spinal or general), treatment, day, and the interaction of day by treatment.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
776 participants
Primary outcome timeframe
Baseline and Days 1-3
Results posted on
2022-02-09
Participant Flow
Participant milestones
| Measure |
Etoricoxib 90 mg
Participants received etoricoxib 90 mg once daily, matching placebo to etoricoxib 120 mg once daily, and matching placebo to ibuprofen 600 mg every 8 hours for 7 days.
|
Etoricoxib 120 mg
Participants received etoricoxib 120 mg once daily, matching placebo to etoricoxib 90 mg once daily, and matching placebo to ibuprofen 600 mg every 8 hours for 7 days.
|
Ibuprofen 1800 mg
Participants received ibuprofen 600 mg every 8 hours, matching placebo to etoricoxib 120 mg once daily, and matching placebo to etoricoxib 90 mg once daily for 7 days.
|
Placebo
Participants received matching placebo to etoricoxib 90 mg and matching placebo to etoricoxib 120 mg once daily, and matching placebo to ibuprofen every 8 hours for 7 days.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
224
|
230
|
224
|
98
|
|
Overall Study
COMPLETED
|
198
|
216
|
203
|
85
|
|
Overall Study
NOT COMPLETED
|
26
|
14
|
21
|
13
|
Reasons for withdrawal
| Measure |
Etoricoxib 90 mg
Participants received etoricoxib 90 mg once daily, matching placebo to etoricoxib 120 mg once daily, and matching placebo to ibuprofen 600 mg every 8 hours for 7 days.
|
Etoricoxib 120 mg
Participants received etoricoxib 120 mg once daily, matching placebo to etoricoxib 90 mg once daily, and matching placebo to ibuprofen 600 mg every 8 hours for 7 days.
|
Ibuprofen 1800 mg
Participants received ibuprofen 600 mg every 8 hours, matching placebo to etoricoxib 120 mg once daily, and matching placebo to etoricoxib 90 mg once daily for 7 days.
|
Placebo
Participants received matching placebo to etoricoxib 90 mg and matching placebo to etoricoxib 120 mg once daily, and matching placebo to ibuprofen every 8 hours for 7 days.
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
15
|
8
|
10
|
5
|
|
Overall Study
Lack of Efficacy
|
2
|
1
|
2
|
2
|
|
Overall Study
Physician Decision
|
0
|
1
|
1
|
0
|
|
Overall Study
Protocol Violation
|
3
|
0
|
4
|
0
|
|
Overall Study
Withdrawal by Subject
|
6
|
4
|
4
|
6
|
Baseline Characteristics
Study of MK-0663/Etoricoxib in Postorthopedic Knee Replacement Surgery Pain (MK-0663-098)
Baseline characteristics by cohort
| Measure |
Etoricoxib 90 mg
n=224 Participants
Participants received etoricoxib 90 mg once daily, matching placebo to etoricoxib 120 mg once daily, and matching placebo to ibuprofen 600 mg every 8 hours for 7 days.
|
Etoricoxib 120 mg
n=230 Participants
Participants received etoricoxib 120 mg once daily, matching placebo to etoricoxib 90 mg once daily, and matching placebo to ibuprofen 600 mg every 8 hours for 7 days.
|
Ibuprofen 1800 mg
n=224 Participants
Participants received ibuprofen 600 mg every 8 hours, matching placebo to etoricoxib 120 mg once daily, and matching placebo to etoricoxib 90 mg once daily for 7 days.
|
Placebo
n=98 Participants
Participants received matching placebo to etoricoxib 90 mg and matching placebo to etoricoxib 120 mg once daily, and matching placebo to ibuprofen every 8 hours for 7 days.
|
Total
n=776 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
65.7 years
STANDARD_DEVIATION 8.5 • n=93 Participants
|
64.7 years
STANDARD_DEVIATION 8.1 • n=4 Participants
|
66.0 years
STANDARD_DEVIATION 8.1 • n=27 Participants
|
65.2 years
STANDARD_DEVIATION 7.9 • n=483 Participants
|
65.4 years
STANDARD_DEVIATION 8.2 • n=36 Participants
|
|
Sex: Female, Male
Female
|
134 Participants
n=93 Participants
|
139 Participants
n=4 Participants
|
152 Participants
n=27 Participants
|
56 Participants
n=483 Participants
|
481 Participants
n=36 Participants
|
|
Sex: Female, Male
Male
|
90 Participants
n=93 Participants
|
91 Participants
n=4 Participants
|
72 Participants
n=27 Participants
|
42 Participants
n=483 Participants
|
295 Participants
n=36 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
6 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
10 Participants
n=36 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
218 Participants
n=93 Participants
|
229 Participants
n=4 Participants
|
222 Participants
n=27 Participants
|
97 Participants
n=483 Participants
|
766 Participants
n=36 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
1 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Asian
|
22 Participants
n=93 Participants
|
14 Participants
n=4 Participants
|
20 Participants
n=27 Participants
|
4 Participants
n=483 Participants
|
60 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Black or African American
|
8 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
2 Participants
n=483 Participants
|
14 Participants
n=36 Participants
|
|
Race (NIH/OMB)
White
|
190 Participants
n=93 Participants
|
212 Participants
n=4 Participants
|
199 Participants
n=27 Participants
|
92 Participants
n=483 Participants
|
693 Participants
n=36 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
6 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
2 Participants
n=36 Participants
|
PRIMARY outcome
Timeframe: Baseline and Days 1-3Population: All randomized participants, excluding those who didn't receive at least 1 dose of study treatment, lacked 1 post-randomization measurement, were randomized at a specific site, or received continuous infusion of morphine by patient control analgesia (PCA). Per protocol, the ibuprofen arm was not included in this outcome measure.
The pain intensity difference was measured at rest over Days 1 through 3 in patients treated with etoricoxib (120 mg, 90 mg) compared to placebo for the treatment of pain following total knee replacement orthopedic surgery. Pain intensity difference at rest was measured on a numerical rating scale (NRS) from 0 - 10 points (0=no pain, to 10=pain as bad as you can imagine). Comparison to placebo was conducted in a step-down manner (the 90-mg dose was evaluated only if the null hypotheses for co-primary endpoints \[Pain Intensity Difference (PID) and Morphine\] 120-mg doses were rejected). The primary analyses for change from baseline in average pain intensity at rest over Days 1 to 3 was performed using the longitudinal data analysis (LDA) method with the terms for baseline pain intensity (moderate or severe), type of anesthesia (spinal or general), treatment, day, and the interaction of day by treatment.
Outcome measures
| Measure |
Ibuprofen 1800 mg
n=96 Participants
Participants received ibuprofen 600 mg every 8 hours, matching placebo to etoricoxib 120 mg once daily, and matching placebo to etoricoxib 90 mg once daily for 7 days.
|
Etoricoxib 120 mg
n=224 Participants
Participants received etoricoxib 120 mg once daily, matching placebo to etoricoxib 90 mg once daily, and matching placebo to ibuprofen 600 mg every 8 hours for 7 days.
|
Etoricoxib 90 mg
n=211 Participants
Participants received etoricoxib 90 mg once daily, matching placebo to etoricoxib 120 mg once daily, and matching placebo to ibuprofen 600 mg every 8 hours for 7 days.
|
Placebo
Participants received matching placebo to etoricoxib 90 mg and matching placebo to etoricoxib 120 mg once daily, and matching placebo to ibuprofen every 8 hours for 7 days.
|
|---|---|---|---|---|
|
Average Change From Baseline for Pain Intensity at Rest Over Days 1 to 3 (Etoricoxib vs. Placebo)
|
-3.39 Score on a scale
Interval -3.74 to -3.04
|
-3.87 Score on a scale
Interval -4.11 to -3.64
|
-3.93 Score on a scale
Interval -4.17 to -3.69
|
—
|
PRIMARY outcome
Timeframe: Days 1-3Population: All randomized participants, excluding those who didn't receive at least 1 dose of study treatment, lacked 1 post-randomization measurement, were randomized at a specific site, or received continuous infusion of morphine by PCA. Per protocol, the ibuprofen arm was not included in this outcome measure.
The average total dose of morphine was assessed when participant received etoricoxib 120 milligram(mg)/90 mg compared to placebo. Opioids taken were converted to mg morphine equivalents according to the following conventions: 1 mg morphine sulphate=1 mg morphine,1 mg morphine hydrochloride=1.17 mg morphine. A 5 mg oxycodone tablet=2.5 mg morphine,12.5 mg meperidine =1.67 mg morphine. Least-squares mean back-transformed; estimate obtained from longitudinal analysis of variance (ANOVA) model on log-transformed morphine dose with terms for baseline pain intensity(moderate or severe),type of anesthesia (spinal, general), treatment, day, and the interaction of day by treatment.
Outcome measures
| Measure |
Ibuprofen 1800 mg
n=96 Participants
Participants received ibuprofen 600 mg every 8 hours, matching placebo to etoricoxib 120 mg once daily, and matching placebo to etoricoxib 90 mg once daily for 7 days.
|
Etoricoxib 120 mg
n=225 Participants
Participants received etoricoxib 120 mg once daily, matching placebo to etoricoxib 90 mg once daily, and matching placebo to ibuprofen 600 mg every 8 hours for 7 days.
|
Etoricoxib 90 mg
n=215 Participants
Participants received etoricoxib 90 mg once daily, matching placebo to etoricoxib 120 mg once daily, and matching placebo to ibuprofen 600 mg every 8 hours for 7 days.
|
Placebo
Participants received matching placebo to etoricoxib 90 mg and matching placebo to etoricoxib 120 mg once daily, and matching placebo to ibuprofen every 8 hours for 7 days.
|
|---|---|---|---|---|
|
Average Total Daily Dose of Postoperative Morphine Over Days 1 to 3 (Etoricoxib vs. Placebo)
|
13.40 milligrams (mg)
Interval 11.2 to 16.0
|
9.25 milligrams (mg)
Interval 8.26 to 10.4
|
8.87 milligrams (mg)
Interval 7.88 to 9.97
|
—
|
PRIMARY outcome
Timeframe: Up to 21 daysPopulation: The analysis population consisted of all randomized patients who received at least one dose of study treatment.
An adverse event (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the study product, is also an AE.
Outcome measures
| Measure |
Ibuprofen 1800 mg
n=223 Participants
Participants received ibuprofen 600 mg every 8 hours, matching placebo to etoricoxib 120 mg once daily, and matching placebo to etoricoxib 90 mg once daily for 7 days.
|
Etoricoxib 120 mg
n=230 Participants
Participants received etoricoxib 120 mg once daily, matching placebo to etoricoxib 90 mg once daily, and matching placebo to ibuprofen 600 mg every 8 hours for 7 days.
|
Etoricoxib 90 mg
n=222 Participants
Participants received etoricoxib 90 mg once daily, matching placebo to etoricoxib 120 mg once daily, and matching placebo to ibuprofen 600 mg every 8 hours for 7 days.
|
Placebo
n=98 Participants
Participants received matching placebo to etoricoxib 90 mg and matching placebo to etoricoxib 120 mg once daily, and matching placebo to ibuprofen every 8 hours for 7 days.
|
|---|---|---|---|---|
|
Percentage of Participants With at Least One Adverse Event of Congestive Heart Failure, Pulmonary Edema, or Cardiac Failure
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
0.5 Percentage of Participants
|
0.0 Percentage of Participants
|
PRIMARY outcome
Timeframe: Up to 21 daysPopulation: The analysis population consisted of all randomized patients who received at least one dose of study treatment.
An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the study product, is also an AE. Edema is swelling caused by excess fluid trapped in body tissues.
Outcome measures
| Measure |
Ibuprofen 1800 mg
n=223 Participants
Participants received ibuprofen 600 mg every 8 hours, matching placebo to etoricoxib 120 mg once daily, and matching placebo to etoricoxib 90 mg once daily for 7 days.
|
Etoricoxib 120 mg
n=230 Participants
Participants received etoricoxib 120 mg once daily, matching placebo to etoricoxib 90 mg once daily, and matching placebo to ibuprofen 600 mg every 8 hours for 7 days.
|
Etoricoxib 90 mg
n=222 Participants
Participants received etoricoxib 90 mg once daily, matching placebo to etoricoxib 120 mg once daily, and matching placebo to ibuprofen 600 mg every 8 hours for 7 days.
|
Placebo
n=98 Participants
Participants received matching placebo to etoricoxib 90 mg and matching placebo to etoricoxib 120 mg once daily, and matching placebo to ibuprofen every 8 hours for 7 days.
|
|---|---|---|---|---|
|
Percentage of Participants With at Least One Edema-Related AE
|
1.8 Percentage of Participants
|
1.7 Percentage of Participants
|
0.9 Percentage of Participants
|
4.1 Percentage of Participants
|
PRIMARY outcome
Timeframe: Up to 21 daysPopulation: The analysis population consisted of all randomized patients who received at least one dose of study treatment.
An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the study product, is also an AE.
Outcome measures
| Measure |
Ibuprofen 1800 mg
n=223 Participants
Participants received ibuprofen 600 mg every 8 hours, matching placebo to etoricoxib 120 mg once daily, and matching placebo to etoricoxib 90 mg once daily for 7 days.
|
Etoricoxib 120 mg
n=230 Participants
Participants received etoricoxib 120 mg once daily, matching placebo to etoricoxib 90 mg once daily, and matching placebo to ibuprofen 600 mg every 8 hours for 7 days.
|
Etoricoxib 90 mg
n=222 Participants
Participants received etoricoxib 90 mg once daily, matching placebo to etoricoxib 120 mg once daily, and matching placebo to ibuprofen 600 mg every 8 hours for 7 days.
|
Placebo
n=98 Participants
Participants received matching placebo to etoricoxib 90 mg and matching placebo to etoricoxib 120 mg once daily, and matching placebo to ibuprofen every 8 hours for 7 days.
|
|---|---|---|---|---|
|
Percentage of Participants With at Least One Hypertension-Related AE
|
3.1 Percentage of Participants
|
1.3 Percentage of Participants
|
3.6 Percentage of Participants
|
3.1 Percentage of Participants
|
PRIMARY outcome
Timeframe: Up to 21 daysPopulation: The analysis population consisted of all randomized patients who received at least one dose of study treatment.
An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the study product, is also an AE. Opioid-related AEs include nausea, vomiting, constipation, somnolence, respiratory depression, urinary retention and ileus.
Outcome measures
| Measure |
Ibuprofen 1800 mg
n=223 Participants
Participants received ibuprofen 600 mg every 8 hours, matching placebo to etoricoxib 120 mg once daily, and matching placebo to etoricoxib 90 mg once daily for 7 days.
|
Etoricoxib 120 mg
n=230 Participants
Participants received etoricoxib 120 mg once daily, matching placebo to etoricoxib 90 mg once daily, and matching placebo to ibuprofen 600 mg every 8 hours for 7 days.
|
Etoricoxib 90 mg
n=222 Participants
Participants received etoricoxib 90 mg once daily, matching placebo to etoricoxib 120 mg once daily, and matching placebo to ibuprofen 600 mg every 8 hours for 7 days.
|
Placebo
n=98 Participants
Participants received matching placebo to etoricoxib 90 mg and matching placebo to etoricoxib 120 mg once daily, and matching placebo to ibuprofen every 8 hours for 7 days.
|
|---|---|---|---|---|
|
Percentage of Participants With at Least One Opioid-Related AE
|
36.3 Percentage of Participants
|
36.5 Percentage of Participants
|
34.7 Percentage of Participants
|
41.8 Percentage of Participants
|
PRIMARY outcome
Timeframe: Up to 7 daysPopulation: The analysis population consisted of all randomized patients who received at least one dose of study treatment.
An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the study product, is also an AE.
Outcome measures
| Measure |
Ibuprofen 1800 mg
n=223 Participants
Participants received ibuprofen 600 mg every 8 hours, matching placebo to etoricoxib 120 mg once daily, and matching placebo to etoricoxib 90 mg once daily for 7 days.
|
Etoricoxib 120 mg
n=230 Participants
Participants received etoricoxib 120 mg once daily, matching placebo to etoricoxib 90 mg once daily, and matching placebo to ibuprofen 600 mg every 8 hours for 7 days.
|
Etoricoxib 90 mg
n=222 Participants
Participants received etoricoxib 90 mg once daily, matching placebo to etoricoxib 120 mg once daily, and matching placebo to ibuprofen 600 mg every 8 hours for 7 days.
|
Placebo
n=98 Participants
Participants received matching placebo to etoricoxib 90 mg and matching placebo to etoricoxib 120 mg once daily, and matching placebo to ibuprofen every 8 hours for 7 days.
|
|---|---|---|---|---|
|
Percentage of Participants Who Discontinued Study Drug Due to an AE
|
4.5 Percentage of Participants
|
3.5 Percentage of Participants
|
6.3 Percentage of Participants
|
5.1 Percentage of Participants
|
SECONDARY outcome
Timeframe: Baseline and Days 1-3Population: All randomized participants, excluding those who didn't receive at least 1 dose of study treatment, lacked 1 post-randomization measurement, were randomized at a specific site, or received continuous infusion of morphine by patient control analgesia (PCA). Per protocol, the placebo arm was not included in this outcome measure.
The pain intensity difference was measured at rest over Days 1 through 3 in participants treated with etoricoxib (120 mg, 90 mg) compared to ibuprofen for the treatment of pain following total knee replacement orthopedic surgery. Pain intensity difference at rest was measured on a numerical rating scale (NRS) from 0 - 10 points (0=no pain, to 10=pain as bad as you can imagine). Comparison to ibuprofen was conducted in a step-down manner (the 90-mg dose was evaluated only if the null hypotheses for co-primary endpoints \[Pain Intensity Difference (PID) and morphine\] 120-mg doses were rejected). The primary analyses for change from baseline in average pain intensity at rest over Days 1 to 3 was performed using the longitudinal data analysis (LDA) method with the terms for baseline pain intensity (moderate or severe), type of anesthesia (spinal or general), treatment, day, and the interaction of day by treatment.
Outcome measures
| Measure |
Ibuprofen 1800 mg
n=216 Participants
Participants received ibuprofen 600 mg every 8 hours, matching placebo to etoricoxib 120 mg once daily, and matching placebo to etoricoxib 90 mg once daily for 7 days.
|
Etoricoxib 120 mg
n=224 Participants
Participants received etoricoxib 120 mg once daily, matching placebo to etoricoxib 90 mg once daily, and matching placebo to ibuprofen 600 mg every 8 hours for 7 days.
|
Etoricoxib 90 mg
n=211 Participants
Participants received etoricoxib 90 mg once daily, matching placebo to etoricoxib 120 mg once daily, and matching placebo to ibuprofen 600 mg every 8 hours for 7 days.
|
Placebo
Participants received matching placebo to etoricoxib 90 mg and matching placebo to etoricoxib 120 mg once daily, and matching placebo to ibuprofen every 8 hours for 7 days.
|
|---|---|---|---|---|
|
Average Change From Baseline for Pain Intensity at Rest Over Days 1 to 3 (Etoricoxib vs. Ibuprofen)
|
-3.83 Score on a scale
Interval -4.07 to -3.59
|
-3.87 Score on a scale
Interval -4.11 to -3.64
|
-3.93 Score on a scale
Interval -4.17 to -3.69
|
—
|
SECONDARY outcome
Timeframe: Days 1-3Population: All randomized participants, excluding those who didn't receive at least 1 dose of study treatment, lacked 1 post-randomization measurement, were randomized at a specific site, or received continuous infusion of morphine by patient control analgesia (PCA). Per protocol, the placebo arm was not included in this outcome measure.
The difference in average total daily dose of morphine used over Days 1 through 3 between participants treated with etoricoxib (120 mg, 90 mg) or ibuprofen 1800 mg (administered as 600 mg three times daily, every 8 hours) in the treatment of pain following total knee replacement orthopedic surgery was assessed. Opioids taken were converted to mg morphine equivalents according to the following conventions:1 mg morphine sulphate = 1 mg morphine, 1 mg morphine hydrochloride = 1.17 mg morphine. A 5 mg oxycodone tablet = 2.5 mg morphine,12.5 mg meperidine = 1.67 mg morphine.
Outcome measures
| Measure |
Ibuprofen 1800 mg
n=217 Participants
Participants received ibuprofen 600 mg every 8 hours, matching placebo to etoricoxib 120 mg once daily, and matching placebo to etoricoxib 90 mg once daily for 7 days.
|
Etoricoxib 120 mg
n=225 Participants
Participants received etoricoxib 120 mg once daily, matching placebo to etoricoxib 90 mg once daily, and matching placebo to ibuprofen 600 mg every 8 hours for 7 days.
|
Etoricoxib 90 mg
n=215 Participants
Participants received etoricoxib 90 mg once daily, matching placebo to etoricoxib 120 mg once daily, and matching placebo to ibuprofen 600 mg every 8 hours for 7 days.
|
Placebo
Participants received matching placebo to etoricoxib 90 mg and matching placebo to etoricoxib 120 mg once daily, and matching placebo to ibuprofen every 8 hours for 7 days.
|
|---|---|---|---|---|
|
Average Total Daily Dose of Postoperative Morphine Over Days 1 to 3 (Etoricoxib vs. Ibuprofen)
|
8.82 milligrams (mg)
Interval 7.85 to 9.91
|
9.25 milligrams (mg)
Interval 8.26 to 10.4
|
8.87 milligrams (mg)
Interval 7.88 to 9.97
|
—
|
Adverse Events
Placebo
Serious events: 4 serious events
Other events: 57 other events
Deaths: 0 deaths
Etoricoxib 90 mg
Serious events: 5 serious events
Other events: 110 other events
Deaths: 0 deaths
Etoricoxib 120 mg
Serious events: 4 serious events
Other events: 116 other events
Deaths: 0 deaths
Ibuprofen 1800mg
Serious events: 5 serious events
Other events: 108 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=98 participants at risk
Participants received matching placebo to etoricoxib 90 mg and matching placebo to etoricoxib 120 mg once daily, and matching placebo to ibuprofen every 8 hours for 7 days.
|
Etoricoxib 90 mg
n=222 participants at risk
Participants received etoricoxib 90 mg once daily, matching placebo to etoricoxib 120 mg once daily, and matching placebo to ibuprofen 600 mg every 8 hours for 7 days.
|
Etoricoxib 120 mg
n=230 participants at risk
Participants received etoricoxib 120 mg once daily, matching placebo to etoricoxib 90 mg once daily, and matching placebo to ibuprofen 600 mg every 8 hours for 7 days.
|
Ibuprofen 1800mg
n=223 participants at risk
Participants received ibuprofen 600 mg every 8 hours, matching placebo to etoricoxib 120 mg once daily, and matching placebo to etoricoxib 90 mg once daily for 7 days.
|
|---|---|---|---|---|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/98 • Up to 21 days post surgery
The analysis population consisted of all randomized patients who received at least one dose of study treatment.
|
0.45%
1/222 • Number of events 1 • Up to 21 days post surgery
The analysis population consisted of all randomized patients who received at least one dose of study treatment.
|
0.43%
1/230 • Number of events 1 • Up to 21 days post surgery
The analysis population consisted of all randomized patients who received at least one dose of study treatment.
|
0.00%
0/223 • Up to 21 days post surgery
The analysis population consisted of all randomized patients who received at least one dose of study treatment.
|
|
Cardiac disorders
Cardiac arrest
|
1.0%
1/98 • Number of events 1 • Up to 21 days post surgery
The analysis population consisted of all randomized patients who received at least one dose of study treatment.
|
0.00%
0/222 • Up to 21 days post surgery
The analysis population consisted of all randomized patients who received at least one dose of study treatment.
|
0.00%
0/230 • Up to 21 days post surgery
The analysis population consisted of all randomized patients who received at least one dose of study treatment.
|
0.00%
0/223 • Up to 21 days post surgery
The analysis population consisted of all randomized patients who received at least one dose of study treatment.
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/98 • Up to 21 days post surgery
The analysis population consisted of all randomized patients who received at least one dose of study treatment.
|
0.00%
0/222 • Up to 21 days post surgery
The analysis population consisted of all randomized patients who received at least one dose of study treatment.
|
0.00%
0/230 • Up to 21 days post surgery
The analysis population consisted of all randomized patients who received at least one dose of study treatment.
|
0.45%
1/223 • Number of events 1 • Up to 21 days post surgery
The analysis population consisted of all randomized patients who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/98 • Up to 21 days post surgery
The analysis population consisted of all randomized patients who received at least one dose of study treatment.
|
0.00%
0/222 • Up to 21 days post surgery
The analysis population consisted of all randomized patients who received at least one dose of study treatment.
|
0.43%
1/230 • Number of events 1 • Up to 21 days post surgery
The analysis population consisted of all randomized patients who received at least one dose of study treatment.
|
0.00%
0/223 • Up to 21 days post surgery
The analysis population consisted of all randomized patients who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Peptic ulcer haemorrhage
|
0.00%
0/98 • Up to 21 days post surgery
The analysis population consisted of all randomized patients who received at least one dose of study treatment.
|
0.45%
1/222 • Number of events 1 • Up to 21 days post surgery
The analysis population consisted of all randomized patients who received at least one dose of study treatment.
|
0.00%
0/230 • Up to 21 days post surgery
The analysis population consisted of all randomized patients who received at least one dose of study treatment.
|
0.00%
0/223 • Up to 21 days post surgery
The analysis population consisted of all randomized patients who received at least one dose of study treatment.
|
|
Infections and infestations
Bacterial infection
|
0.00%
0/98 • Up to 21 days post surgery
The analysis population consisted of all randomized patients who received at least one dose of study treatment.
|
0.00%
0/222 • Up to 21 days post surgery
The analysis population consisted of all randomized patients who received at least one dose of study treatment.
|
0.00%
0/230 • Up to 21 days post surgery
The analysis population consisted of all randomized patients who received at least one dose of study treatment.
|
0.45%
1/223 • Number of events 1 • Up to 21 days post surgery
The analysis population consisted of all randomized patients who received at least one dose of study treatment.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/98 • Up to 21 days post surgery
The analysis population consisted of all randomized patients who received at least one dose of study treatment.
|
0.00%
0/222 • Up to 21 days post surgery
The analysis population consisted of all randomized patients who received at least one dose of study treatment.
|
0.00%
0/230 • Up to 21 days post surgery
The analysis population consisted of all randomized patients who received at least one dose of study treatment.
|
0.45%
1/223 • Number of events 1 • Up to 21 days post surgery
The analysis population consisted of all randomized patients who received at least one dose of study treatment.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/98 • Up to 21 days post surgery
The analysis population consisted of all randomized patients who received at least one dose of study treatment.
|
0.00%
0/222 • Up to 21 days post surgery
The analysis population consisted of all randomized patients who received at least one dose of study treatment.
|
0.00%
0/230 • Up to 21 days post surgery
The analysis population consisted of all randomized patients who received at least one dose of study treatment.
|
0.45%
1/223 • Number of events 1 • Up to 21 days post surgery
The analysis population consisted of all randomized patients who received at least one dose of study treatment.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/98 • Up to 21 days post surgery
The analysis population consisted of all randomized patients who received at least one dose of study treatment.
|
0.45%
1/222 • Number of events 1 • Up to 21 days post surgery
The analysis population consisted of all randomized patients who received at least one dose of study treatment.
|
0.00%
0/230 • Up to 21 days post surgery
The analysis population consisted of all randomized patients who received at least one dose of study treatment.
|
0.00%
0/223 • Up to 21 days post surgery
The analysis population consisted of all randomized patients who received at least one dose of study treatment.
|
|
Infections and infestations
Urinary tract infection
|
1.0%
1/98 • Number of events 1 • Up to 21 days post surgery
The analysis population consisted of all randomized patients who received at least one dose of study treatment.
|
0.00%
0/222 • Up to 21 days post surgery
The analysis population consisted of all randomized patients who received at least one dose of study treatment.
|
0.00%
0/230 • Up to 21 days post surgery
The analysis population consisted of all randomized patients who received at least one dose of study treatment.
|
0.00%
0/223 • Up to 21 days post surgery
The analysis population consisted of all randomized patients who received at least one dose of study treatment.
|
|
Infections and infestations
Wound infection
|
0.00%
0/98 • Up to 21 days post surgery
The analysis population consisted of all randomized patients who received at least one dose of study treatment.
|
0.45%
1/222 • Number of events 1 • Up to 21 days post surgery
The analysis population consisted of all randomized patients who received at least one dose of study treatment.
|
0.00%
0/230 • Up to 21 days post surgery
The analysis population consisted of all randomized patients who received at least one dose of study treatment.
|
0.00%
0/223 • Up to 21 days post surgery
The analysis population consisted of all randomized patients who received at least one dose of study treatment.
|
|
Injury, poisoning and procedural complications
Anaemia postoperative
|
1.0%
1/98 • Number of events 1 • Up to 21 days post surgery
The analysis population consisted of all randomized patients who received at least one dose of study treatment.
|
0.00%
0/222 • Up to 21 days post surgery
The analysis population consisted of all randomized patients who received at least one dose of study treatment.
|
0.00%
0/230 • Up to 21 days post surgery
The analysis population consisted of all randomized patients who received at least one dose of study treatment.
|
0.00%
0/223 • Up to 21 days post surgery
The analysis population consisted of all randomized patients who received at least one dose of study treatment.
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.00%
0/98 • Up to 21 days post surgery
The analysis population consisted of all randomized patients who received at least one dose of study treatment.
|
0.00%
0/222 • Up to 21 days post surgery
The analysis population consisted of all randomized patients who received at least one dose of study treatment.
|
0.43%
1/230 • Number of events 1 • Up to 21 days post surgery
The analysis population consisted of all randomized patients who received at least one dose of study treatment.
|
0.00%
0/223 • Up to 21 days post surgery
The analysis population consisted of all randomized patients who received at least one dose of study treatment.
|
|
Nervous system disorders
Transient ischaemic attack
|
1.0%
1/98 • Number of events 1 • Up to 21 days post surgery
The analysis population consisted of all randomized patients who received at least one dose of study treatment.
|
0.00%
0/222 • Up to 21 days post surgery
The analysis population consisted of all randomized patients who received at least one dose of study treatment.
|
0.00%
0/230 • Up to 21 days post surgery
The analysis population consisted of all randomized patients who received at least one dose of study treatment.
|
0.00%
0/223 • Up to 21 days post surgery
The analysis population consisted of all randomized patients who received at least one dose of study treatment.
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/98 • Up to 21 days post surgery
The analysis population consisted of all randomized patients who received at least one dose of study treatment.
|
0.00%
0/222 • Up to 21 days post surgery
The analysis population consisted of all randomized patients who received at least one dose of study treatment.
|
0.00%
0/230 • Up to 21 days post surgery
The analysis population consisted of all randomized patients who received at least one dose of study treatment.
|
0.45%
1/223 • Number of events 1 • Up to 21 days post surgery
The analysis population consisted of all randomized patients who received at least one dose of study treatment.
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
1.0%
1/98 • Number of events 1 • Up to 21 days post surgery
The analysis population consisted of all randomized patients who received at least one dose of study treatment.
|
0.00%
0/222 • Up to 21 days post surgery
The analysis population consisted of all randomized patients who received at least one dose of study treatment.
|
0.00%
0/230 • Up to 21 days post surgery
The analysis population consisted of all randomized patients who received at least one dose of study treatment.
|
0.45%
1/223 • Number of events 1 • Up to 21 days post surgery
The analysis population consisted of all randomized patients who received at least one dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/98 • Up to 21 days post surgery
The analysis population consisted of all randomized patients who received at least one dose of study treatment.
|
0.45%
1/222 • Number of events 1 • Up to 21 days post surgery
The analysis population consisted of all randomized patients who received at least one dose of study treatment.
|
0.43%
1/230 • Number of events 1 • Up to 21 days post surgery
The analysis population consisted of all randomized patients who received at least one dose of study treatment.
|
0.00%
0/223 • Up to 21 days post surgery
The analysis population consisted of all randomized patients who received at least one dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.00%
0/98 • Up to 21 days post surgery
The analysis population consisted of all randomized patients who received at least one dose of study treatment.
|
0.45%
1/222 • Number of events 1 • Up to 21 days post surgery
The analysis population consisted of all randomized patients who received at least one dose of study treatment.
|
0.00%
0/230 • Up to 21 days post surgery
The analysis population consisted of all randomized patients who received at least one dose of study treatment.
|
0.00%
0/223 • Up to 21 days post surgery
The analysis population consisted of all randomized patients who received at least one dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
1.0%
1/98 • Number of events 1 • Up to 21 days post surgery
The analysis population consisted of all randomized patients who received at least one dose of study treatment.
|
0.00%
0/222 • Up to 21 days post surgery
The analysis population consisted of all randomized patients who received at least one dose of study treatment.
|
0.00%
0/230 • Up to 21 days post surgery
The analysis population consisted of all randomized patients who received at least one dose of study treatment.
|
0.00%
0/223 • Up to 21 days post surgery
The analysis population consisted of all randomized patients who received at least one dose of study treatment.
|
Other adverse events
| Measure |
Placebo
n=98 participants at risk
Participants received matching placebo to etoricoxib 90 mg and matching placebo to etoricoxib 120 mg once daily, and matching placebo to ibuprofen every 8 hours for 7 days.
|
Etoricoxib 90 mg
n=222 participants at risk
Participants received etoricoxib 90 mg once daily, matching placebo to etoricoxib 120 mg once daily, and matching placebo to ibuprofen 600 mg every 8 hours for 7 days.
|
Etoricoxib 120 mg
n=230 participants at risk
Participants received etoricoxib 120 mg once daily, matching placebo to etoricoxib 90 mg once daily, and matching placebo to ibuprofen 600 mg every 8 hours for 7 days.
|
Ibuprofen 1800mg
n=223 participants at risk
Participants received ibuprofen 600 mg every 8 hours, matching placebo to etoricoxib 120 mg once daily, and matching placebo to etoricoxib 90 mg once daily for 7 days.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Constipation
|
13.3%
13/98 • Number of events 15 • Up to 21 days post surgery
The analysis population consisted of all randomized patients who received at least one dose of study treatment.
|
11.7%
26/222 • Number of events 27 • Up to 21 days post surgery
The analysis population consisted of all randomized patients who received at least one dose of study treatment.
|
13.9%
32/230 • Number of events 36 • Up to 21 days post surgery
The analysis population consisted of all randomized patients who received at least one dose of study treatment.
|
13.5%
30/223 • Number of events 30 • Up to 21 days post surgery
The analysis population consisted of all randomized patients who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Dyspepsia
|
8.2%
8/98 • Number of events 9 • Up to 21 days post surgery
The analysis population consisted of all randomized patients who received at least one dose of study treatment.
|
2.3%
5/222 • Number of events 5 • Up to 21 days post surgery
The analysis population consisted of all randomized patients who received at least one dose of study treatment.
|
3.9%
9/230 • Number of events 11 • Up to 21 days post surgery
The analysis population consisted of all randomized patients who received at least one dose of study treatment.
|
4.5%
10/223 • Number of events 11 • Up to 21 days post surgery
The analysis population consisted of all randomized patients who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Nausea
|
31.6%
31/98 • Number of events 37 • Up to 21 days post surgery
The analysis population consisted of all randomized patients who received at least one dose of study treatment.
|
22.5%
50/222 • Number of events 63 • Up to 21 days post surgery
The analysis population consisted of all randomized patients who received at least one dose of study treatment.
|
24.3%
56/230 • Number of events 78 • Up to 21 days post surgery
The analysis population consisted of all randomized patients who received at least one dose of study treatment.
|
23.8%
53/223 • Number of events 70 • Up to 21 days post surgery
The analysis population consisted of all randomized patients who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Vomiting
|
13.3%
13/98 • Number of events 15 • Up to 21 days post surgery
The analysis population consisted of all randomized patients who received at least one dose of study treatment.
|
12.2%
27/222 • Number of events 29 • Up to 21 days post surgery
The analysis population consisted of all randomized patients who received at least one dose of study treatment.
|
13.0%
30/230 • Number of events 43 • Up to 21 days post surgery
The analysis population consisted of all randomized patients who received at least one dose of study treatment.
|
14.8%
33/223 • Number of events 37 • Up to 21 days post surgery
The analysis population consisted of all randomized patients who received at least one dose of study treatment.
|
|
General disorders
Pyrexia
|
27.6%
27/98 • Number of events 33 • Up to 21 days post surgery
The analysis population consisted of all randomized patients who received at least one dose of study treatment.
|
5.9%
13/222 • Number of events 13 • Up to 21 days post surgery
The analysis population consisted of all randomized patients who received at least one dose of study treatment.
|
10.9%
25/230 • Number of events 29 • Up to 21 days post surgery
The analysis population consisted of all randomized patients who received at least one dose of study treatment.
|
10.3%
23/223 • Number of events 25 • Up to 21 days post surgery
The analysis population consisted of all randomized patients who received at least one dose of study treatment.
|
|
Nervous system disorders
Dizziness
|
3.1%
3/98 • Number of events 5 • Up to 21 days post surgery
The analysis population consisted of all randomized patients who received at least one dose of study treatment.
|
6.3%
14/222 • Number of events 15 • Up to 21 days post surgery
The analysis population consisted of all randomized patients who received at least one dose of study treatment.
|
6.5%
15/230 • Number of events 23 • Up to 21 days post surgery
The analysis population consisted of all randomized patients who received at least one dose of study treatment.
|
6.3%
14/223 • Number of events 15 • Up to 21 days post surgery
The analysis population consisted of all randomized patients who received at least one dose of study treatment.
|
|
Psychiatric disorders
Insomnia
|
11.2%
11/98 • Number of events 13 • Up to 21 days post surgery
The analysis population consisted of all randomized patients who received at least one dose of study treatment.
|
10.4%
23/222 • Number of events 27 • Up to 21 days post surgery
The analysis population consisted of all randomized patients who received at least one dose of study treatment.
|
9.1%
21/230 • Number of events 26 • Up to 21 days post surgery
The analysis population consisted of all randomized patients who received at least one dose of study treatment.
|
7.6%
17/223 • Number of events 20 • Up to 21 days post surgery
The analysis population consisted of all randomized patients who received at least one dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
4.1%
4/98 • Number of events 7 • Up to 21 days post surgery
The analysis population consisted of all randomized patients who received at least one dose of study treatment.
|
6.3%
14/222 • Number of events 15 • Up to 21 days post surgery
The analysis population consisted of all randomized patients who received at least one dose of study treatment.
|
6.1%
14/230 • Number of events 25 • Up to 21 days post surgery
The analysis population consisted of all randomized patients who received at least one dose of study treatment.
|
4.9%
11/223 • Number of events 12 • Up to 21 days post surgery
The analysis population consisted of all randomized patients who received at least one dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
4.1%
4/98 • Number of events 4 • Up to 21 days post surgery
The analysis population consisted of all randomized patients who received at least one dose of study treatment.
|
8.6%
19/222 • Number of events 19 • Up to 21 days post surgery
The analysis population consisted of all randomized patients who received at least one dose of study treatment.
|
6.5%
15/230 • Number of events 19 • Up to 21 days post surgery
The analysis population consisted of all randomized patients who received at least one dose of study treatment.
|
7.6%
17/223 • Number of events 17 • Up to 21 days post surgery
The analysis population consisted of all randomized patients who received at least one dose of study treatment.
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp.
Phone: 1-800-672-6372
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The SPONSOR must have the opportunity to review all proposed abstracts, manuscripts, or presentations regarding this study 60 days prior to submission for publication/presentation. Any information identified by the SPONSOR as confidential must be deleted prior to submission. SPONSOR review can be expedited to meet publication guidelines.
- Publication restrictions are in place
Restriction type: OTHER