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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