A Study of Two Approved Drugs in the Treatment of Postoperative Dental Pain (0966-183)

Phase 3

Completed

• Conditions: Postoperative Pain

• Registration Number: NCT00092326
• Lead Sponsor: Merck Sharp & Dohme LLC

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 Timeline

• Study Start: 2002-06
• Primary Completion: 2002-09
• Study Completion: 2002-09
• Study First Submitted: 2004-09-22
• Study First Submitted QC: 2004-09-24
• Study First Posted: 2004-09-27
• Status Verified: 2016-02
• Last Update Submitted: 2016-02-19
• Last Update Posted: 2016-02-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 269

Inclusion Criteria

• Impaction of a molar tooth requiring removal

Exclusion Criteria

• Any known allergy to the study drugs

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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 Measures

Name	Time	Method
Time to onset of analgesic effect, peak analgesic effect, and/or duration of analgesic effect over 24 hours.