A Study of Two Approved Drugs in the Treatment of Postoperative Dental Pain - Full Text View

Sponsor:	Merck
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00092326

Purpose

The purpose of this study is to compare the safety and effectiveness of two approved drugs in the treatment of pain following dental surgery.

Condition	Intervention	Phase
Postoperative Pain	Drug: MK0966, rofecoxib Drug: Comparator: oxycodone with acetaminophen, placebo	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Randomized, Double-Blind, Placebo- and Active-Comparator-Controlled Study to Evaluate the Efficacy of Rofecoxib and a Dosing Regimen of Oxycodone With Acetaminophen Over 24 Hours in Patients With Postoperative Dental Pain

Resource links provided by NLM:

MedlinePlus related topics: Surgery

Drug Information available for: Oxycodone Acetaminophen Rofecoxib CT 2584 Oxycodone hydrochloride

U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:

Post-op dental pain over 6 hours as measured by pain intensity/relief scores, patient global assessment, and time to perceptible/meaningful pain relief.

Secondary Outcome Measures:

Time to onset of analgesic effect, peak analgesic effect, and/or duration of analgesic effect over 24 hours.

Estimated Enrollment:	270
Study Start Date:	June 2002

Detailed Description:

The duration of treatment is 24 hours.

Eligibility

Ages Eligible for Study:	16 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Impaction of a molar tooth requiring removal

Exclusion Criteria:

Any known allergy to the study drugs

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00092326

Sponsors and Collaborators

Merck

Investigators

Study Director:

Medical Monitor

Merck

More Information

Publications:

Desjardins PJ, Black PM, Daniels SE, Bird SR, Petruschke RA, Chang DJ, Smugar SS, Tershakovec AM. A double-blind randomized controlled trial of rofecoxib and multidose oxycodone/acetaminophen in dental impaction pain. J Oral Maxillofac Surg. 2007 Aug;65(8):1624-32. No abstract available.

Responsible Party:	Merck & Co., Inc. ( Executive Vice President, Clinical and Quantitative Sciences )
Study ID Numbers:	2004_068, MK0966-183
Study First Received:	September 22, 2004
Last Updated:	April 20, 2009
ClinicalTrials.gov Identifier:	NCT00092326 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Merck:

dental surgery
molar removal

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Oxycodone
Pain
Cyclooxygenase 2 Inhibitors
Signs and Symptoms
Pathologic Processes
Sensory System Agents
Therapeutic Uses
Anti-Inflammatory Agents, Non-Steroidal
Analgesics
Acetaminophen

Pain, Postoperative
Analgesics, Opioid
Cyclooxygenase Inhibitors
Central Nervous System Depressants
Narcotics
Enzyme Inhibitors
Pharmacologic Actions
Postoperative Complications
Analgesics, Non-Narcotic
Rofecoxib
Peripheral Nervous System Agents
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on November 27, 2009