Pain, PostoperativePhase 3NCT00820027

Study of MK-0663/Etoricoxib in Postorthopedic Knee Replacement Surgery Pain (MK-0663-098)

A Phase 3 study testing Etoricoxib 90 mg, Etoricoxib 120 mg and Ibuprofen 600 mg in people with Pain, Postoperative, run by Organon and Co.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Pain, Postoperative
What is being tested?: Etoricoxib 90 mg, Etoricoxib 120 mg and Ibuprofen 600 mg
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 776 participants
Where: No sites listed yet
Study dates: 15 Dec 2008to 14 Dec 2010
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Is in generally good health and is scheduled to have a total knee replacement

Who cannot join

Is allergic, intolerant to, or has a history of a significant clinical or laboratory adverse experience associated with etoricoxib or other cyclooxygenase-2 (COX-2) inhibitors/non-steroidal anti-inflammatory drugs (NSAIDs), ibuprofen, morphine, or oxycodone, or has hypersensitivity to aspirin, or other NSAIDs
Has uncontrolled hypertension
Is currently a user of any illicit drugs, or has a history of drug or alcohol abuse within the past 5 years

About this study

Official title: A Phase III Randomized, Double-Blind, Placebo- and Active-Comparator-Controlled, Multiple-Dose, Clinical Trial to Study the Safety and Efficacy of MK0663/Etoricoxib and Ibuprofen in the Treatment of Postorthopedic Knee Replacement Surgery Pain

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.

Conditions: Pain, Postoperative
Being tested: Etoricoxib 90 mg, Etoricoxib 120 mg, Ibuprofen 600 mg, Matching Placebo for Etoricoxib 120 mg, Matching Placebo for Etoricoxib 90 mg
Medical subject headings: Pain, Postoperative

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Etoricoxib 90 mgDrug
Also called MK-0663
One 90 mg tablet once daily
Etoricoxib 120 mgDrug
Also called MK-0663
Two 60 mg tablets once daily
Ibuprofen 600 mgDrug
One tablet three times daily
Matching Placebo for Etoricoxib 120 mgDrug
Two tablets once daily
Matching Placebo for Etoricoxib 90 mgDrug
One tablet once daily
Matching Placebo for IbuprofenDrug
One tablet three times daily
MorphineDrug
As needed via patient-controlled analgesia (PCA) device or as a bolus intravenous injection
OxycodoneDrug
5 mg as needed

Study groups in NCT00820027
Study group	Role	What they receive
Etoricoxib 90 mg	Experimental	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. Receives: Drug: Etoricoxib 90 mg; Drug: Matching Placebo for Etoricoxib 120 mg; Drug: Matching Placebo for Ibuprofen; Drug: Morphine; Drug: Oxycodone
Etoricoxib 120 mg	Experimental	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. Receives: Drug: Etoricoxib 120 mg; Drug: Matching Placebo for Etoricoxib 90 mg; Drug: Matching Placebo for Ibuprofen; Drug: Morphine; Drug: Oxycodone
Ibuprofen 1800 mg	Active comparator	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. Receives: Drug: Ibuprofen 600 mg; Drug: Matching Placebo for Etoricoxib 120 mg; Drug: Matching Placebo for Etoricoxib 90 mg; Drug: Morphine; Drug: Oxycodone
Placebo	Placebo comparator	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. Receives: Drug: Matching Placebo for Etoricoxib 120 mg; Drug: Matching Placebo for Etoricoxib 90 mg; Drug: Matching Placebo for Ibuprofen; Drug: Morphine; Drug: Oxycodone

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to 7 days

Secondary outcomes (2)

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.
Measured: 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.
Measured: Days 1-3

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Dec 200814 Dec 2010

First posted9 Jan 2009 (estimated)
Study start15 Dec 2008
Primary completion13 Dec 2010
Study completion14 Dec 2010

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 776 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00820027
Sponsor's protocol ID: 0663-098
Other IDs: 2009_502
Status last verified: Feb 2022
First submitted: 7 Jan 2009
Last updated: 9 Feb 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Rawal N, Viscusi E, Peloso PM, Minkowitz HS, Chen L, Shah S, Mehta A, Chitkara DK, Curtis SP, Papanicolaou DA. Evaluation of etoricoxib in patients undergoing total knee replacement surgery in a double-blind, randomized controlled trial. BMC Musculoskelet Disord. 2013 Oct 24;14:300. doi: 10.1186/1471-2474-14-300.
PubMed 24156640

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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Study at a glance

From the registry record, last updated by the sponsor on 9 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase III Randomized, Double-Blind, Placebo- and Active-Comparator-Controlled, Multiple-Dose, Clinical Trial to Study the Safety and Efficacy of MK0663/Etoricoxib and Ibuprofen in the Treatment of Postorthopedic Knee Replacement Surgery Pain
ClinicalTrials.gov ID: NCT00820027
Acronym / sponsor ID: 0663-098
Conditions: Pain, Postoperative
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 776 participants (actual)
Lead sponsor: Organon and CoIndustry (pharma, biotech, devices)
Study start: 15 Dec 2008 (actual)
Primary completion: 13 Dec 2010 (actual)
Study completion: 14 Dec 2010 (actual)
First posted: 9 Jan 2009 (estimated)
Results: Posted 7 Apr 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 4

Arm	Type	Receives
Etoricoxib 90 mg	Experimental	Drug: Etoricoxib 90 mg, Drug: Matching Placebo for Etoricoxib 120 mg, Drug: Matching Placebo for Ibuprofen, Drug: Morphine, Drug: OxycodoneParticipants 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	Experimental	Drug: Etoricoxib 120 mg, Drug: Matching Placebo for Etoricoxib 90 mg, Drug: Matching Placebo for Ibuprofen, Drug: Morphine, Drug: OxycodoneParticipants 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	Active comparator	Drug: Ibuprofen 600 mg, Drug: Matching Placebo for Etoricoxib 120 mg, Drug: Matching Placebo for Etoricoxib 90 mg, Drug: Morphine, Drug: OxycodoneParticipants 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	Placebo comparator	Drug: Matching Placebo for Etoricoxib 120 mg, Drug: Matching Placebo for Etoricoxib 90 mg, Drug: Matching Placebo for Ibuprofen, Drug: Morphine, Drug: OxycodoneParticipants 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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

Is in generally good health and is scheduled to have a total knee replacement

Key exclusion criteria (3 listed)

Is allergic, intolerant to, or has a history of a significant clinical or laboratory adverse experience associated with etoricoxib or other cyclooxygenase-2 (COX-2) inhibitors/non-steroidal anti-inflammatory drugs (NSAIDs), ibuprofen, morphine, or oxycodone, or has hypersensitivity to aspirin, or other NSAIDs
Has uncontrolled hypertension
Is currently a user of any illicit drugs, or has a history of drug or alcohol abuse within the past 5 years

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Etoricoxib 90 mgAlso: MK-0663One 90 mg tablet once daily	Drug	Etoricoxib 90 mg
Etoricoxib 120 mgAlso: MK-0663Two 60 mg tablets once daily	Drug	Etoricoxib 120 mg
Ibuprofen 600 mgOne tablet three times daily	Drug	Ibuprofen 1800 mg
Matching Placebo for Etoricoxib 120 mgTwo tablets once daily	Drug	Etoricoxib 90 mg, Ibuprofen 1800 mg, Placebo
Matching Placebo for Etoricoxib 90 mgOne tablet once daily	Drug	Etoricoxib 120 mg, Ibuprofen 1800 mg, Placebo
Matching Placebo for IbuprofenOne tablet three times daily	Drug	Etoricoxib 120 mg, Etoricoxib 90 mg, Placebo
MorphineAs needed via patient-controlled analgesia (PCA) device or as a bolus intravenous injection	Drug	Etoricoxib 120 mg, Etoricoxib 90 mg, Ibuprofen 1800 mg, Placebo
Oxycodone5 mg as needed	Drug	Etoricoxib 120 mg, Etoricoxib 90 mg, Ibuprofen 1800 mg, Placebo

Primary outcome

Average Change From Baseline for Pain Intensity at Rest Over Days 1 to 3 (Etoricoxib vs. Placebo)
Time frame: Baseline and Days 1-3
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.
Average Total Daily Dose of Postoperative Morphine Over Days 1 to 3 (Etoricoxib vs. Placebo)
Time frame: Days 1-3
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.
Percentage of Participants With at Least One Adverse Event of Congestive Heart Failure, Pulmonary Edema, or Cardiac Failure
Time frame: Up to 21 days
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 With at Least One Edema-Related AE
Time frame: Up to 21 days
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 With at Least One Hypertension-Related AE
Time frame: Up to 21 days
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 With at Least One Opioid-Related AE
Time frame: Up to 21 days
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 Who Discontinued Study Drug Due to an AE
Time frame: Up to 7 days
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.

2 secondary outcomes

Average Change From Baseline for Pain Intensity at Rest Over Days 1 to 3 (Etoricoxib vs. Ibuprofen)
Time frame: Baseline and Days 1-3
Average Total Daily Dose of Postoperative Morphine Over Days 1 to 3 (Etoricoxib vs. Ibuprofen)
Time frame: Days 1-3

Results and safety

Results posted to the registry on 7 Apr 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Etoricoxib 90 mg	224	198
Etoricoxib 120 mg	230	216
Ibuprofen 1800 mg	224	203
Placebo	98	85

Primary outcome: Average Change From Baseline for Pain Intensity at Rest Over Days 1 to 3 (Etoricoxib vs. Placebo)

Time frame: Baseline and Days 1-3. Least squares mean (95% Confidence Interval). Unit: Score on a scale

Measure	Etoricoxib 90 mg n = 211	Etoricoxib 120 mg n = 224	Placebo n = 96
Value	-3.93 (-4.17 to -3.69)	-3.87 (-4.11 to -3.64)	-3.39 (-3.74 to -3.04)

Etoricoxib 120 mg vs Placebo: Difference in Least Squares Mean: -0.49 (95% CI -0.89 to -0.08), p = 0.018, longitudinal data analysis (LDA)
Etoricoxib 90 mg vs Placebo: Difference in Least Squares Mean: -0.54 (95% CI -0.95 to -0.14), p = 0.009, LDA

Population analysed: 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.

Primary outcome: Average Total Daily Dose of Postoperative Morphine Over Days 1 to 3 (Etoricoxib vs. Placebo)

Time frame: Days 1-3. Geometric least squares mean (95% Confidence Interval). Unit: milligrams (mg)

Measure	Etoricoxib 90 mg n = 215	Etoricoxib 120 mg n = 225	Placebo n = 96
Value	8.87 (7.88 to 9.97)	9.25 (8.26 to 10.40)	13.40 (11.20 to 16.00)

Etoricoxib 120 mg vs Placebo: Between-Treatment Ratio: 0.69 (95% CI 0.56 to 0.85), p <0.001, ANOVA
Etoricoxib 90 mg vs Placebo: Between-Treatment Ratio: 0.66 (95% CI 0.54 to 0.82), p <0.001, ANOVA

Population analysed: 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.

Primary outcome: Percentage of Participants With at Least One Adverse Event of Congestive Heart Failure, Pulmonary Edema, or Cardiac Failure

Time frame: Up to 21 days. Number. Unit: Percentage of Participants

Measure	Etoricoxib 90 mg n = 222	Etoricoxib 120 mg n = 230	Ibuprofen 1800 mg n = 223	Placebo n = 98
Value	0.5	0.0	0.0	0.0

Etoricoxib 90 mg vs Placebo: Difference in Percent: 0.5 (95% CI -3.3 to 2.5), p = 0.506, Miettinen & Nurminen
Etoricoxib 120 mg vs Placebo: Difference in Percent: 0.0 (95% CI -3.8 to 1.7), p >0.999, Miettinen & Nurminen
Ibuprofen 1800 mg vs Placebo: Difference in Percent: 0.0 (95% CI -3.8 to 1.7), p >0.999, Miettinen & Nurminen

Population analysed: The analysis population consisted of all randomized patients who received at least one dose of study treatment.

Primary outcome: Percentage of Participants With at Least One Edema-Related AE

Time frame: Up to 21 days. Number. Unit: Percentage of Participants

Measure	Etoricoxib 90 mg n = 222	Etoricoxib 120 mg n = 230	Ibuprofen 1800 mg n = 223	Placebo n = 98
Value	0.9	1.7	1.8	4.1

Etoricoxib 90 mg vs Placebo: Difference in Percent: -3.2 (95% CI -9.2 to 0.1), p = 0.054, Miettinen & Nurminen
Etoricoxib 120 mg vs Placebo: Difference in Percent: -2.3 (95% CI -8.4 to 1.2), p = 0.209, Miettinen & Nurminen
Ibuprofen 1800 mg vs Placebo: Difference in Percent: -2.3 (95% CI -8.4 to 1.3), p = 0.227, Miettinen & Nurminen

Population analysed: The analysis population consisted of all randomized patients who received at least one dose of study treatment.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to 21 days post surgery. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	4 of 98 (4.1%)	57 of 98 (58.2%)	0 of 98
Etoricoxib 90 mg	5 of 222 (2.3%)	110 of 222 (49.5%)	0 of 222
Etoricoxib 120 mg	4 of 230 (1.7%)	116 of 230 (50.4%)	0 of 230
Ibuprofen 1800mg	5 of 223 (2.2%)	108 of 223 (48.4%)	0 of 223

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 24156640Rawal N, Viscusi E, Peloso PM, Minkowitz HS, Chen L, Shah S, Mehta A, Chitkara DK, Curtis SP, Papanicolaou DA. Evaluation of etoricoxib in patients undergoing total knee replacement surgery in a double-blind, randomized controlled trial. BMC Musculoskelet Disord. 2013 Oct 24;14:300. doi: 10.1186/1471-2474-14-300.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Medical Director study director

Merck Sharp & Dohme LLC

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Etoricoxib 90 mg, Etoricoxib 120 mg and Ibuprofen 600 mg in people with Pain, Postoperative, run by Organon and Co.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 7 Apr 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Average Change From Baseline for Pain Intensity at Rest Over Days 1 to 3 (Etoricoxib vs. Placebo) (time frame: Baseline and Days 1-3). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00820027, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2022.