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”

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

Study Type: Interventional

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

The duration of treatment is 24 hours.

Intervention(s) in this Clinical Trial

• Drug: MK0966, rofecoxib
• Drug: Comparator: oxycodone with acetaminophen, placebo

Primary 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 Measures

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

Inclusion Criteria:

• Impaction of a molar tooth requiring removal

Exclusion Criteria:

• Any known allergy to the study drugs

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 16 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Merck

Information obtained from ClinicalTrials.gov on August 08, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00092326

Study ID Number: 2004_068

ClinicalTrials.gov Identifier: NCT00092326

Health Authority: United States: Food and Drug Administration