Effect of Rofecoxib and a Narcotic Analgesic to Treat Pain Following Arthroscopic Surgery.

Verified by: Merck, October 2007
First Received: October 18, 2006 | Last Updated: October 9, 2007 | Phase: Phase 3 | Start Date: February 2002
Overall Status: Completed | Estimated Enrollment: 420
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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...

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”

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: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

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

Secondary Measures

  • Total Pain Relief over 6 hours following a single oral dose compared to hydrocodone + acetaminophen.
    • 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 Investigator Information

Lead Investigator: Merck Industry

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 February 09, 2012

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

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