A Study of Two Approved Drugs in the Treatment of Postoperative Dental Pain (0966-181)(COMPLETED)

Phase 3

Completed

• Conditions: Postoperative Pain

• Registration Number: NCT00092300
• 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 1 day.

Study Timeline

• Study Start: 2002-05
• Primary Completion: 2002-09
• Study First Submitted: 2004-09-22
• Study First Submitted QC: 2004-09-27
• Study First Posted: 2004-09-28
• Status Verified: 2015-07
• Last Update Submitted: 2015-07-31
• Last Update Posted: 2015-08-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 450

Inclusion Criteria

• Impaction of a molar tooth requiring removal

Exclusion Criteria

• Known allergies to the study drug

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Overall analgesic effect over 12 hours.

Secondary Outcome Measures

Name	Time	Method
Safety and tolerability.
Time to onset of analgesic, peak analgesic and duration of analgesic effects.
Overall analgesic, time to onset of analgesic, peak analgesic, and duration analgesic effects
Overall analgesic effect over 8 hours.