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

Organon

Status and phase: Completed; Phase 3

Conditions: Pain, Postoperative

Treatments: Drug: Oxycodone; Drug: Ibuprofen 600 mg; Drug: Morphine; Drug: Etoricoxib 120 mg; Drug: Matching Placebo for Etoricoxib 90 mg; Drug: Matching Placebo for Ibuprofen; Drug: Matching Placebo for Etoricoxib 120 mg; Drug: Etoricoxib 90 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT00820027

2009_502 (Other Identifier)

0663-098

Details and patient eligibility

About

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.

Enrollment: 776 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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776 participants in 4 patient groups, including a placebo group

Etoricoxib 90 mg

Experimental group

Description:

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.

Treatment:

Drug: Etoricoxib 90 mg

Drug: Matching Placebo for Ibuprofen

Drug: Oxycodone

Drug: Morphine

Drug: Matching Placebo for Etoricoxib 120 mg

Etoricoxib 120 mg

Experimental group

Description:

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.

Treatment:

Drug: Matching Placebo for Ibuprofen

Drug: Matching Placebo for Etoricoxib 90 mg

Drug: Oxycodone

Drug: Etoricoxib 120 mg

Drug: Morphine

Ibuprofen 1800 mg

Active Comparator group

Description:

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.

Treatment:

Drug: Matching Placebo for Etoricoxib 90 mg

Drug: Ibuprofen 600 mg

Drug: Oxycodone

Drug: Morphine

Drug: Matching Placebo for Etoricoxib 120 mg

Placebo

Placebo Comparator group

Description:

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.

Treatment:

Drug: Matching Placebo for Ibuprofen

Drug: Matching Placebo for Etoricoxib 90 mg

Drug: Oxycodone

Drug: Morphine

Drug: Matching Placebo for Etoricoxib 120 mg