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

This study has been completed.

First Received: October 18, 2006 Last Updated: October 9, 2007 History of Changes

Sponsor:	Merck
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00390260

Purpose

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.

Condition	Intervention	Phase
Pain, Postoperative Arthroscopy.	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	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
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

Resource links provided by NLM:

MedlinePlus related topics: Surgery

Drug Information available for: Acetaminophen Rofecoxib CT 2584 Hydrocodone Hydrocodone bitartrate Hycodan

U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:

Total Pain Relief over 6 hours following a single oral dose compared to placebo. [ Time Frame: 6 hours ]

Secondary Outcome Measures:

Total Pain Relief over 6 hours following a single oral dose compared to hydrocodone + acetaminophen. [ Time Frame: 6 hours ]

Estimated Enrollment:	420
Study Start Date:	February 2002

Eligibility

Ages Eligible for Study:	18 Years to 60 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00390260

Sponsors and Collaborators

Merck

Investigators

Study Director:

Medical Monitor

Merck

More Information

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.

Study ID Numbers:	2006_535
Study First Received:	October 18, 2006
Last Updated:	October 9, 2007
ClinicalTrials.gov Identifier:	NCT00390260 History of Changes
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Respiratory System Agents
Physiological Effects of Drugs
Central Nervous System Depressants
Pain
Narcotics
Pharmacologic Actions
Signs and Symptoms
Pathologic Processes
Postoperative Complications
Analgesics, Non-Narcotic

Sensory System Agents
Therapeutic Uses
Hydrocodone
Analgesics
Peripheral Nervous System Agents
Antitussive Agents
Central Nervous System Agents
Analgesics, Opioid
Pain, Postoperative
Acetaminophen

ClinicalTrials.gov processed this record on February 08, 2010