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

April 20, 2009

Start Date ^ICMJE

June 2002

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

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 NCT00092326 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Condition ^ICMJE

Postoperative Pain

Intervention ^ICMJE

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

Study Arms / Comparison Groups

Publications *

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.

* 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:

Any known allergy to the study drugs

Gender

Both

Ages

16 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Administrative Information

NCT ID ^ICMJE

NCT00092326

Responsible Party

Executive Vice President, Clinical and Quantitative Sciences, Merck & Co., Inc.

Study ID Numbers ^ICMJE

2004_068, MK0966-183

Study Sponsor ^ICMJE

Merck

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Medical Monitor

Merck

Information Provided By

Merck

Verification Date

April 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP