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

Pain, Postoperative Clinical Trial

Official title:

A Randomized Double-blind, Placebo-and Active Comparator-Controlled 2-Part Study to Evaluate the Efficacy of MK2295 in Patients With Postoperative Dental Pain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00387140
• Other study ID #: 2295-005
• Secondary ID: MK2295-0052006_5
• Status: Completed
• Phase: Phase 2
• First received: October 9, 2006
• Last updated: October 30, 2015
• Start date: October 2006
• Est. completion date: May 2007

Study information

• Verified date: October 2015
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 89
• Est. completion date: May 2007
• Est. primary completion date: May 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 45 Years

Eligibility

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

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain, Postoperative
• Tooth Extraction
• Toothache

Intervention

Drug:
• MK2295

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Peak analgesic response, safety, and tolerability		Over 24 Hours	Yes
Secondary	Onset of analgesia, duration of analgesia		Over 24 Hours	No