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: May 17, 2006
Verified by: Merck, October 2005
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):
Intervention(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, 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 and acetaminophen
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:
- 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
Related Publications
References
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.
Additional Information
Information obtained from ClinicalTrials.gov on October 10, 2008
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00092313
Study ID Number: 2004_067
ClinicalTrials.gov Identifier: NCT00092313
Health Authority: United States: Food and Drug Administration
Clinical Trials Authorship and Review
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