Effect of Rofecoxib and a Narcotic Analgesic to Treat Pain Following Arthroscopic Surgery.
Information source: Merck
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Pain, Postoperative Arthroscopy.
Intervention: 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 (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Merck Official(s) and/or principal investigator(s):
Medical Monitor, Study Director, Affiliation: Merck
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.
Clinical Details
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
Study design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Total Pain Relief over 6 hours following a single oral dose compared to placebo.
Secondary outcome: Total Pain Relief over 6 hours following a single oral dose compared to hydrocodone + acetaminophen.
Eligibility
Minimum age: 18 Years.
Maximum age: 60 Years.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Additional Information
Related publications: 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.
Starting date: February 2002
Last updated: October 9, 2007
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