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

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 3

Conditions: Pain, Postoperative Arthroscopy

Treatments: Drug: Comparator: placebo (unspecified) / Duration of Treatment: 1 Days; Drug: Comparator: acetaminophen (+) hydrocodone bitartrate / Duration of Treatment: 1 Days; Drug: MK0966 / Duration of Treatment: 1 Days

Study type: Interventional

Funder types: Industry

Identifiers

NCT00390260

2006_535

0966-179

Details and patient eligibility

About

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.

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind