A Study to Evaluate the Safety and Efficacy of an Investigational Drug in the Treatment of Postoperative Dental Pain (MK-2295-005)

Phase 2

Completed

• Conditions: Tooth Extraction; Pain, Postoperative

• Registration Number: NCT00387140
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief Summary

This study is being conducted to evaluate the safety and tolerability of the drug and to evaluate its efficacy compared to placebo and to ibuprofen in the treatment of postoperative dental pain in male patients.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2006-10
• Study First Submitted: 2006-10-09
• Study First Submitted QC: 2006-10-09
• Study First Posted: 2006-10-12
• Primary Completion: 2007-05
• Study Completion: 2007-05
• Status Verified: 2015-10
• Last Update Submitted: 2015-10-30
• Last Update Posted: 2015-11-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 89

Inclusion Criteria

• Patients in generally good health who are scheduled to have two or more third molars removed, at least one of which is partially or completely embedded in bone and is a mandibular impaction

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Exclusion Criteria

• Patient has a temperature of 37.5C or greater prior to dosing
• Patient has participated in another clinical study within the last 4 weeks

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Peak analgesic response, safety, and tolerability	Over 24 Hours

Secondary Outcome Measures

Name	Time	Method
Onset of analgesia, duration of analgesia	Over 24 Hours