A Study of Two Approved Drugs in the Treatment of Postoperative Dental Pain
Information source: Merck
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Postoperative Pain
Intervention: MK0966, rofecoxib (Drug); Comparator: oxycodone and acetaminophen (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Merck
Summary
The purpose of this study is to compare the safety and effectiveness of two approved drugs in
the treatment of pain following dental surgery.
Clinical Details
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
Study design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: 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: Time to onset of analgesic effect, peak analgesic effect, and/or duration of analgesic effect over 24 hours.
Detailed description:
The duration of treatment is 24 hours.
Eligibility
Minimum age: 16 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Impaction of a molar tooth requiring removal
Exclusion Criteria:
- Known allergy to the study drugs
Locations and Contacts
Additional Information
Related publications: 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.
Starting date: June 2002
Last updated: May 17, 2006
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