Effect of Rofecoxib and a Narcotic Analgesic to Treat Pain Following Arthroscopic Surgery (0966-179)(COMPLETED)

Phase 3

Completed

• Conditions: Pain, Postoperative Arthroscopy

• Registration Number: NCT00390260
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief Summary

Study the effect of rofecoxib 50 mg compared to both placebo, and hydrocodone 7.5 mg with acetaminophen 750 mg, to treat moderate to severe pain following arthroscopic knee surgery.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2002-02
• Primary Completion: 2003-02
• Study Completion: 2003-02
• Study First Submitted: 2006-10-18
• Study First Submitted QC: 2006-10-18
• Study First Posted: 2006-10-19
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-31
• Last Update Posted: 2017-02-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 420

Inclusion Criteria

• Elective outpatient arthroscopic knee surgery expected to last <= 90 minutes using general anesthesia
• Patients must experience moderate to severe pain following surgery
• Patient must be in general good health as judged by the primary investigator

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Exclusion Criteria

• Osteoarthritis; rheumatoid arthritis
• Allergy/sensitivity to aspirin, ibuprofen, indomethacin, other NSAIDs, COX-2 inhibitors (e.g., rofecoxib, celecoxib), hydrocodone, acetaminophen
• Asthma associated with nasal polyps
• Any arthroscopic knee surgery in the past 6 months

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Total Pain Relief over 6 hours following a single oral dose compared to placebo.	6 hours

Secondary Outcome Measures

Name	Time	Method
Total Pain Relief over 6 hours following a single oral dose compared to hydrocodone + acetaminophen.	6 hours