A Study of Two Approved Drugs in the Treatment of 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...

Date First Received: September 22, 2004

Last Updated: April 20, 2009

Verified by: Merck, April 2009

Clinical Trial Phase: Phase 3 | Start Date: June 2002

Overall Status: Completed

Estimated Enrollment: 270

Brief Summary

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”

Condition Keyword(s):

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 (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Detailed Clinical Trial Description

The duration of treatment is 24 hours.

Intervention(s) in this Clinical Trial

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

Outcome Measures for this Clinical Trial

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.

Criteria for Participation in this Clinical Trial

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

Clinical Trial Sponsor Information

Lead Sponsor: Merck

Overall Clinical Trial Officials and Contacts

Medical Monitor Study Director Merck  

Related Publications

References

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.

Additional Information

Information obtained from ClinicalTrials.gov on July 02, 2009

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

Clinical Trials Authorship and Review

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