A Phase 3 interventional study of Etoricoxib 90 mg and Etoricoxib 120 mg in Pain, Postoperative, sponsored by Organon and Co. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-02-09.
Sponsored by Organon and Co · Phase 3, Interventional, and Treatment
The purpose of this study was to evaluate the efficacy and safety of Etoricoxib compared to placebo and ibuprofen in the treatment of postoperative pain associated with unilateral total knee replacement surgery. The hypotheses for this study were that the average pain intensity difference (at rest) in participants treated with Etoricoxib (120 mg, 90 mg) is superior to placebo, the average total daily dose of morphine in participants treated with Etoricoxib (120 mg, 90 mg) is less than in participants treated with placebo, and that Etoricoxib (120 mg, 90 mg) will be generally safe and well tolerated by participants treated for pain following total knee replacement orthopedic surgery.
5,093 studies on the registry are indexed under Pain, Postoperative; 1,140 are open to participants now.
This study's enrollment of 776 is above the median of 75 across 4,344 interventional studies indexed under Pain, Postoperative.
Browse Pain, Postoperative studies →Organon and Co is the lead sponsor of 478 studies on the registry; none are open to participants now.
Of its 21 completed or terminated interventional studies of FDA-regulated products, 17 (81%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Drug: Etoricoxib 90 mg · Drug: Matching Placebo for Etoricoxib 120 mg · Drug: Matching Placebo for Ibuprofen · Drug: Morphine · Drug: Oxycodone
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.
Drug: Etoricoxib 120 mg · Drug: Matching Placebo for Etoricoxib 90 mg · Drug: Matching Placebo for Ibuprofen · Drug: Morphine · Drug: Oxycodone
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.
Drug: Ibuprofen 600 mg · Drug: Matching Placebo for Etoricoxib 120 mg · Drug: Matching Placebo for Etoricoxib 90 mg · Drug: Morphine · Drug: Oxycodone
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.
Drug: Matching Placebo for Etoricoxib 120 mg · Drug: Matching Placebo for Etoricoxib 90 mg · Drug: Matching Placebo for Ibuprofen · Drug: Morphine · Drug: Oxycodone
One 90 mg tablet once daily
Also known as: MK-0663
Two 60 mg tablets once daily
Also known as: MK-0663
One tablet three times daily
Two tablets once daily
One tablet once daily
One tablet three times daily
As needed via patient-controlled analgesia (PCA) device or as a bolus intravenous injection
5 mg as needed
Average Change From Baseline for Pain Intensity at Rest Over Days 1 to 3 (Etoricoxib vs. Placebo)
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.
Time frame: Baseline and Days 1-3
Average Total Daily Dose of Postoperative Morphine Over Days 1 to 3 (Etoricoxib vs. Placebo)
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.
Time frame: Days 1-3
Percentage of Participants With at Least One Adverse Event of Congestive Heart Failure, Pulmonary Edema, or Cardiac Failure
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.
Time frame: Up to 21 days
Percentage of Participants With at Least One Edema-Related AE
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.
Time frame: Up to 21 days
Percentage of Participants With at Least One Hypertension-Related AE
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.
Time frame: Up to 21 days
Percentage of Participants With at Least One Opioid-Related AE
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.
Time frame: Up to 21 days
Percentage of Participants Who Discontinued Study Drug Due to an AE
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.
Time frame: Up to 7 days
Average Change From Baseline for Pain Intensity at Rest Over Days 1 to 3 (Etoricoxib vs. Ibuprofen)
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.
Time frame: Baseline and Days 1-3
Average Total Daily Dose of Postoperative Morphine Over Days 1 to 3 (Etoricoxib vs. Ibuprofen)
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.
Time frame: Days 1-3
| Milestone | Etoricoxib 90 mg | Etoricoxib 120 mg | Ibuprofen 1800 mg | Placebo |
|---|---|---|---|---|
| Started | 224 | 230 | 224 | 98 |
| Completed | 198 | 216 | 203 | 85 |
| Not completed | 26 | 14 | 21 | 13 |
| Withdrew: Adverse event | 15 | 8 | 10 | 5 |
| Withdrew: Lack of efficacy | 2 | 1 | 2 | 2 |
| Withdrew: Physician decision | 0 | 1 | 1 | 0 |
| Withdrew: Protocol violation | 3 | 0 | 4 | 0 |
| Withdrew: Withdrawal by subject | 6 | 4 | 4 | 6 |
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.
| Score on a scale | Etoricoxib 90 mg | Etoricoxib 120 mg | Placebo |
|---|---|---|---|
| Average Change From Baseline for Pain Intensity at Rest Over Days 1 to 3 (Etoricoxib vs. Placebo) | -3.93 (-4.17 to -3.69) | -3.87 (-4.11 to -3.64) | -3.39 (-3.74 to -3.04) |
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.
| milligrams (mg) | Etoricoxib 90 mg | Etoricoxib 120 mg | Placebo |
|---|---|---|---|
| Average Total Daily Dose of Postoperative Morphine Over Days 1 to 3 (Etoricoxib vs. Placebo) | 8.87 (7.88 to 9.97) | 9.25 (8.26 to 10.40) | 13.40 (11.20 to 16.00) |
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.
| Percentage of Participants | Etoricoxib 90 mg | Etoricoxib 120 mg | Ibuprofen 1800 mg | Placebo |
|---|---|---|---|---|
| Percentage of Participants With at Least One Adverse Event of Congestive Heart Failure, Pulmonary Edema, or Cardiac Failure | 0.5 | 0.0 | 0.0 | 0.0 |
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.
| Percentage of Participants | Etoricoxib 90 mg | Etoricoxib 120 mg | Ibuprofen 1800 mg | Placebo |
|---|---|---|---|---|
| Percentage of Participants With at Least One Edema-Related AE | 0.9 | 1.7 | 1.8 | 4.1 |
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.
| Percentage of Participants | Etoricoxib 90 mg | Etoricoxib 120 mg | Ibuprofen 1800 mg | Placebo |
|---|---|---|---|---|
| Percentage of Participants With at Least One Hypertension-Related AE | 3.6 | 1.3 | 3.1 | 3.1 |
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.
| Percentage of Participants | Etoricoxib 90 mg | Etoricoxib 120 mg | Ibuprofen 1800 mg | Placebo |
|---|---|---|---|---|
| Percentage of Participants With at Least One Opioid-Related AE | 34.7 | 36.5 | 36.3 | 41.8 |
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.
| Score on a scale | Etoricoxib 90 mg | Etoricoxib 120 mg | Ibuprofen 1800 mg |
|---|---|---|---|
| Average Change From Baseline for Pain Intensity at Rest Over Days 1 to 3 (Etoricoxib vs. Ibuprofen) | -3.93 (-4.17 to -3.69) | -3.87 (-4.11 to -3.64) | -3.83 (-4.07 to -3.59) |
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.
| milligrams (mg) | Etoricoxib 90 mg | Etoricoxib 120 mg | Ibuprofen 1800 mg |
|---|---|---|---|
| Average Total Daily Dose of Postoperative Morphine Over Days 1 to 3 (Etoricoxib vs. Ibuprofen) | 8.87 (7.88 to 9.97) | 9.25 (8.26 to 10.4) | 8.82 (7.85 to 9.91) |
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.
| Percentage of Participants | Etoricoxib 90 mg | Etoricoxib 120 mg | Ibuprofen 1800 mg | Placebo |
|---|---|---|---|---|
| Percentage of Participants Who Discontinued Study Drug Due to an AE | 6.3 | 3.5 | 4.5 | 5.1 |
Collected over Up to 21 days post surgery. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Placebo | 0/98 (0%) | 4/98 (4.1%) | 57/98 (58.2%) |
| Etoricoxib 90 mg | 0/222 (0%) | 5/222 (2.3%) | 110/222 (49.5%) |
| Etoricoxib 120 mg | 0/230 (0%) | 4/230 (1.7%) | 116/230 (50.4%) |
| Ibuprofen 1800mg | 0/223 (0%) | 5/223 (2.2%) | 108/223 (48.4%) |
| Event | Placebo | Etoricoxib 90 mg | Etoricoxib 120 mg | Ibuprofen 1800mg |
|---|---|---|---|---|
| Cardiac arrestCardiac disorders | 1/98 | 0/222 | 0/230 | 0/223 |
| Urinary tract infectionInfections and infestations | 1/98 | 0/222 | 0/230 | 0/223 |
| Anaemia postoperativeInjury, poisoning and procedural complications | 1/98 | 0/222 | 0/230 | 0/223 |
| Transient ischaemic attackNervous system disorders | 1/98 | 0/222 | 0/230 | 0/223 |
| Benign prostatic hyperplasiaReproductive system and breast disorders | 1/98 | 0/222 | 0/230 | 1/223 |
| Respiratory failureRespiratory, thoracic and mediastinal disorders | 1/98 | 0/222 | 0/230 | 0/223 |
| Acute myocardial infarctionCardiac disorders | 0/98 | 1/222 | 1/230 | 0/223 |
| Peptic ulcer haemorrhageGastrointestinal disorders | 0/98 | 1/222 | 0/230 | 0/223 |
| PneumoniaInfections and infestations | 0/98 | 1/222 | 0/230 | 0/223 |
| Wound infectionInfections and infestations | 0/98 | 1/222 | 0/230 | 0/223 |
| Event | Placebo | Etoricoxib 90 mg | Etoricoxib 120 mg | Ibuprofen 1800mg |
|---|---|---|---|---|
| NauseaGastrointestinal disorders | 31/98 | 50/222 | 56/230 | 53/223 |
| PyrexiaGeneral disorders | 27/98 | 13/222 | 25/230 | 23/223 |
| VomitingGastrointestinal disorders | 13/98 | 27/222 | 30/230 | 33/223 |
| ConstipationGastrointestinal disorders | 13/98 | 26/222 | 32/230 | 30/223 |
| InsomniaPsychiatric disorders | 11/98 | 23/222 | 21/230 | 17/223 |
| PruritusSkin and subcutaneous tissue disorders | 4/98 | 19/222 | 15/230 | 17/223 |
| DyspepsiaGastrointestinal disorders | 8/98 | 5/222 | 9/230 | 10/223 |
| DizzinessNervous system disorders | 3/98 | 14/222 | 15/230 | 14/223 |
| HyperhidrosisSkin and subcutaneous tissue disorders | 4/98 | 14/222 | 14/230 | 11/223 |
| Age, Continuous(years) | Etoricoxib 90 mg | Etoricoxib 120 mg | Ibuprofen 1800 mg | Placebo | Total |
|---|---|---|---|---|---|
| Mean | 65.7 ± 8.5 | 64.7 ± 8.1 | 66.0 ± 8.1 | 65.2 ± 7.9 | 65.4 ± 8.2 |
| Sex: Female, Male(Participants) | Etoricoxib 90 mg | Etoricoxib 120 mg | Ibuprofen 1800 mg | Placebo | Total |
|---|---|---|---|---|---|
| Female | 134 | 139 | 152 | 56 | 481 |
| Male | 90 | 91 | 72 | 42 | 295 |
| Ethnicity (NIH/OMB)(Participants) | Etoricoxib 90 mg | Etoricoxib 120 mg | Ibuprofen 1800 mg | Placebo | Total |
|---|---|---|---|---|---|
| Hispanic or Latino | 6 | 1 | 2 | 1 | 10 |
| Not Hispanic or Latino | 218 | 229 | 222 | 97 | 766 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Etoricoxib 90 mg | Etoricoxib 120 mg | Ibuprofen 1800 mg | Placebo | Total |
|---|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 1 | 0 | 1 |
| Asian | 22 | 14 | 20 | 4 | 60 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 | 0 |
| Black or African American | 8 | 2 | 2 | 2 | 14 |
| White | 190 | 212 | 199 | 92 | 693 |
| More than one race | 3 | 1 | 2 | 0 | 6 |
| Unknown or Not Reported | 1 | 1 | 0 | 0 | 2 |
No study locations are listed for this record.
This study is completed, as verified in Feb 2022. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Organon and Co