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

Sponsored by:	Merck
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00092313

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 and acetaminophen	Phase III

Drug Information available for: Rofecoxib Oxycodone Oxycodone hydrochloride Acetaminophen

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, 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

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:

Known allergy to the study drugs

Contacts and Locations

No Contacts or Locations Provided

More Information

Publications:

Chang DJ, Desjardins PJ, Bird SR, Black P, Chen E, Petruschke RA, Geba GP. Comparison of rofecoxib and a multidose oxycodone/ acetaminophen regimen for the treatment of acute pain following oral surgery: a randomized controlled trial. Curr Med Res Opin. 2004 Jun;20(6):939-49.

Study ID Numbers:	2004_067
Study First Received:	September 22, 2004
Last Updated:	May 17, 2006
ClinicalTrials.gov Identifier:	NCT00092313
Health Authority:	United States: Food and Drug Administration

Keywords provided by Merck:

dental surgery
molar removal

Study placed in the following topic categories:

Signs and Symptoms
Postoperative Complications
Toothache
Oxycodone

Rofecoxib
Pain
Acetaminophen
Pain, Postoperative

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Molecular Mechanisms of Pharmacological Action
Cyclooxygenase Inhibitors
Physiological Effects of Drugs
Central Nervous System Depressants
Enzyme Inhibitors
Narcotics
Cyclooxygenase 2 Inhibitors
Pharmacologic Actions
Pathologic Processes

Analgesics, Non-Narcotic
Sensory System Agents
Therapeutic Uses
Anti-Inflammatory Agents, Non-Steroidal
Analgesics
Peripheral Nervous System Agents
Antirheumatic Agents
Central Nervous System Agents
Analgesics, Opioid

ClinicalTrials.gov processed this record on January 14, 2009