A Study of Two Approved Drugs in the Treatment of Postoperative Dental Pain - Tabular View

Tracking Information
First Received Date ^ICMJE	September 22, 2004
Last Updated Date	May 17, 2006
Start Date ^ICMJE	June 2002
Primary Completion Date
Current Primary Outcome Measures ^ICMJE (submitted: February 28, 2006)	Post-op dental pain over 6 hours as measured by pain intensity/relief scores, patient global assessment, and time to perceptible/meaningful pain relief.
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00092313 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: February 28, 2006)	Time to onset of analgesic effect, peak analgesic effect, and/or duration of analgesic effect over 24 hours.
Original Secondary Outcome Measures ^ICMJE	Same as current

Descriptive Information
Brief Title ^ICMJE	A Study of Two Approved Drugs in the Treatment of Postoperative Dental Pain
Official Title ^ICMJE	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
Brief 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.
Detailed Description	The duration of treatment is 24 hours.
Study Phase	Phase III
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Condition ^ICMJE	Postoperative Pain
Intervention ^ICMJE	Drug: MK0966, rofecoxib Drug: Comparator: oxycodone and acetaminophen
Study Arms / Comparison Groups
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.
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	270
Completion Date
Primary Completion Date
Eligibility Criteria ^ICMJE	Inclusion Criteria: Impaction of a molar tooth requiring removal Exclusion Criteria: Known allergy to the study drugs
Gender	Both
Ages	16 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE

Administrative Information
NCT ID ^ICMJE	NCT00092313
Responsible Party
Study ID Numbers ^ICMJE	2004_067
Study Sponsor ^ICMJE	Merck
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	Merck
Verification Date	October 2005
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP