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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

776 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-12-15

Study Completion Date

2010-12-14

Brief Summary

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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.

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Detailed Description

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Conditions

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Pain, Postoperative

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Ibuprofen 600 mg

Intervention Type DRUG

One tablet three times daily

Matching Placebo for Etoricoxib 120 mg

Intervention Type DRUG

Two tablets once daily

Matching Placebo for Etoricoxib 90 mg

Intervention Type DRUG

One tablet once daily

Morphine

Intervention Type DRUG

As needed via patient-controlled analgesia (PCA) device or as a bolus intravenous injection

Oxycodone

Intervention Type DRUG

5 mg as needed

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.

Group Type PLACEBO_COMPARATOR

Matching Placebo for Etoricoxib 120 mg

Intervention Type DRUG

Two tablets once daily

Matching Placebo for Etoricoxib 90 mg

Intervention Type DRUG

One tablet once daily

Matching Placebo for Ibuprofen

Intervention Type DRUG

One tablet three times daily

Morphine

Intervention Type DRUG

As needed via patient-controlled analgesia (PCA) device or as a bolus intravenous injection

Oxycodone

Intervention Type DRUG

5 mg as needed

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.

Group Type EXPERIMENTAL

Etoricoxib 90 mg

Intervention Type DRUG

One 90 mg tablet once daily

Matching Placebo for Etoricoxib 120 mg

Intervention Type DRUG

Two tablets once daily

Matching Placebo for Ibuprofen

Intervention Type DRUG

One tablet three times daily

Morphine

Intervention Type DRUG

As needed via patient-controlled analgesia (PCA) device or as a bolus intravenous injection

Oxycodone

Intervention Type DRUG

5 mg as needed

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.

Group Type EXPERIMENTAL

Etoricoxib 120 mg

Intervention Type DRUG

Two 60 mg tablets once daily

Matching Placebo for Etoricoxib 90 mg

Intervention Type DRUG

One tablet once daily

Matching Placebo for Ibuprofen

Intervention Type DRUG

One tablet three times daily

Morphine

Intervention Type DRUG

As needed via patient-controlled analgesia (PCA) device or as a bolus intravenous injection

Oxycodone

Intervention Type DRUG

5 mg as needed

Interventions

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Etoricoxib 90 mg

One 90 mg tablet once daily

Intervention Type DRUG

Etoricoxib 120 mg

Two 60 mg tablets once daily

Intervention Type DRUG

Ibuprofen 600 mg

One tablet three times daily

Intervention Type DRUG

Matching Placebo for Etoricoxib 120 mg

Two tablets once daily

Intervention Type DRUG

Matching Placebo for Etoricoxib 90 mg

One tablet once daily

Intervention Type DRUG

Matching Placebo for Ibuprofen

One tablet three times daily

Intervention Type DRUG

Morphine

As needed via patient-controlled analgesia (PCA) device or as a bolus intravenous injection

Intervention Type DRUG

Oxycodone

5 mg as needed

Intervention Type DRUG

Other Intervention Names

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MK-0663 MK-0663

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No