Completed

Etoricoxib and Ibuprofen for Postoperative Knee Replacement Surgery Pain

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Study Aim

This study aims to evaluate the effectiveness of Etoricoxib and Ibuprofen in managing pain after knee replacement surgery, comparing it to a placebo, by measuring pain intensity at rest and total daily morphine dose over the first three days post-surgery, and monitoring any adverse events related to the treatment.

What is being tested

Etoricoxib 90 mg

+ Matching Placebo for Etoricoxib 120 mg

+ Matching Placebo for Ibuprofen

Drug
Who is being recruted

Neurologic Manifestations+4

+ Pain

+ Pain, Postoperative

Over 18 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Placebo-ControlledPhase 3
Interventional
Study Start: December 2008
See protocol details

Summary

Principal SponsorOrganon and Co
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: December 15, 2008

Actual date on which the first participant was enrolled.

This clinical trial aims to assess the safety and effectiveness of a drug called Etoricoxib in managing pain after knee replacement surgery. The study involves individuals who have undergone a unilateral total knee replacement and compares the results of Etoricoxib treatment to a placebo (a pill with no active medicine) and another pain relief medication, ibuprofen. The main goals are to see if Etoricoxib can reduce pain more effectively than a placebo and if it requires less additional pain medication, like morphine. It's important to find effective pain management strategies after such surgeries to improve patient recovery and comfort. During the trial, participants' pain levels will be measured at rest over the first three days after surgery, using a scale from 0 to 10. The total daily dose of morphine needed for pain relief will also be recorded. Safety is a key focus, with the study monitoring for any side effects related to heart failure, fluid retention (edema), high blood pressure (hypertension), and opioid use. The study also keeps track of any participants who stop using the study drug due to adverse effects.

Official TitleA 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
NCT00820027
Principal SponsorOrganon and Co
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

776 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Neurologic ManifestationsPainPain, PostoperativePathologic ProcessesPostoperative ComplicationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Criteria

Inclusion Criteria: \- Is in generally good health and is scheduled to have a total knee replacement Exclusion Criteria: * 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

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

4 intervention groups are designated in this study

25% chance of being blinded to the placebo group

Treatment Groups

Group I

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.

Group II

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.

Group III

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.

Group IV

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.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
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CompletedNo study centers