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

Pain, Postoperative Arthroscopy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00390260
• Other study ID #: 0966-179
• Secondary ID: 2006_535
• Status: Completed
• Phase: Phase 3
• First received: October 18, 2006
• Last updated: January 31, 2017
• Start date: February 2002
• Est. completion date: February 2003

Study information

• Verified date: January 2017
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 420
• Est. completion date: February 2003
• Est. primary completion date: February 2003
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Pain, Postoperative
• Pain, Postoperative Arthroscopy

Intervention

Drug:
• MK0966 / Duration of Treatment: 1 Days

• Comparator: acetaminophen (+) hydrocodone bitartrate / Duration of Treatment: 1 Days

• Comparator: placebo (unspecified) / Duration of Treatment: 1 Days

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total Pain Relief over 6 hours following a single oral dose compared to placebo.		6 hours
Secondary	Total Pain Relief over 6 hours following a single oral dose compared to hydrocodone + acetaminophen.		6 hours