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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

420 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-02-28

Study Completion Date

2003-02-28

Brief Summary

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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.

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Detailed Description

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Conditions

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Pain, Postoperative Arthroscopy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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MK0966 / Duration of Treatment: 1 Days

Intervention Type DRUG

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

Intervention Type DRUG

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

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No