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

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

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:

Any known allergy to the study drugs

Contacts and Locations

No Contacts or Locations Provided

More Information

Study ID Numbers:	2004_068
First Received:	September 22, 2004
Last Updated:	May 17, 2006
ClinicalTrials.gov Identifier:	NCT00092326
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 November 30, 2008

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