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

Merck Sharp & Dohme LLC0 sites269 target enrollmentJune 2002

ConditionsPostoperative Pain

DrugsMK0966, rofecoxib Comparator: oxycodone with acetaminophen, placebo

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Postoperative Pain
Sponsor: Merck Sharp & Dohme LLC
Enrollment: 269
Primary Endpoint: Post-op dental pain over 6 hours as measured by pain intensity/relief scores, patient global assessment, and time to perceptible/meaningful pain relief.
Status: Completed
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

June 2002

End Date

September 2002

Last Updated

10 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Merck Sharp & Dohme LLC

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Impaction of a molar tooth requiring removal

Exclusion Criteria

•Any known allergy to the study drugs

Outcomes

Primary Outcomes

Post-op dental pain over 6 hours as measured by pain intensity/relief scores, patient global assessment, and time to perceptible/meaningful pain relief.