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...
Date First Received: October 18, 2006
Last Updated: October 9, 2007
Verified by: Merck, October 2007
Clinical Trial Phase: Phase 3 | Start Date: February 2002
Overall Status: Completed
Estimated Enrollment: 420
Brief Summary
Official Title: “Randomized, Double-Blind, Placebo-Controlled Trial of the Effect of Rofecoxib 50 mg and Hydrocodone 7.5 mg With Acetaminophen 750 mg in Patients With Postoperative Arthroscopic Pain”
Condition Keyword(s):
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.
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Intervention(s) in this Clinical Trial
- Drug: MK0966 / Duration of Treatment: 1 Days
- Drug: Comparator: acetaminophen (+) hydrocodone bitartrate / Duration of Treatment: 1 Days
- Drug: Comparator: placebo (unspecified) / Duration of Treatment: 1 Days
Outcome Measures for this Clinical Trial
Primary Measures
- Total Pain Relief over 6 hours following a single oral dose compared to placebo.
- Time Frame: 6 hours
- Time Frame: 6 hours
Secondary Measures
- Total Pain Relief over 6 hours following a single oral dose compared to hydrocodone + acetaminophen.
- Time Frame: 6 hours
- Time Frame: 6 hours
Criteria for Participation in this Clinical Trial
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
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
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 18 Years
Maximum Age for this Clinical Trial: 60 Years
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Sponsor Information
Lead Sponsor: Merck
Overall Clinical Trial Officials and Contacts
Medical Monitor Study Director Merck
Related Publications
References
Chelly JE, Nissen CW, Rodgers AJ, Smugar SS, Tershakovec AM. The efficacy of rofecoxib 50 mg and hydrocodone/acetaminophen 7.5/750 mg in patients with post-arthroscopic pain. Curr Med Res Opin. 2007 Jan;23(1):195-206.
Additional Information
Information obtained from ClinicalTrials.gov on October 10, 2008
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00390260
Study ID Number: 2006_535
ClinicalTrials.gov Identifier: NCT00390260
Health Authority: United States: Food and Drug Administration
Clinical Trials Authorship and Review
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