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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00387140
Recruitment Status : Completed
First Posted : October 12, 2006
Last Update Posted : November 2, 2015
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

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.

Condition or disease Intervention/treatment Phase
Pain, Postoperative Tooth Extraction Drug: MK2295 Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 89 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Study Start Date : October 2006
Actual Primary Completion Date : May 2007
Actual Study Completion Date : May 2007

Primary Outcome Measures :
  1. Peak analgesic response, safety, and tolerability [ Time Frame: Over 24 Hours ]

Secondary Outcome Measures :
  1. Onset of analgesia, duration of analgesia [ Time Frame: Over 24 Hours ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00387140

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Study Director: Medical Monitor Merck Sharp & Dohme Corp.

Responsible Party: Merck Sharp & Dohme Corp. Identifier: NCT00387140     History of Changes
Other Study ID Numbers: 2295-005
First Posted: October 12, 2006    Key Record Dates
Last Update Posted: November 2, 2015
Last Verified: October 2015

Keywords provided by Merck Sharp & Dohme Corp.:
Dental Pain, Postoperative

Additional relevant MeSH terms:
Pain, Postoperative
Neurologic Manifestations
Nervous System Diseases
Postoperative Complications
Pathologic Processes
Signs and Symptoms
Tooth Diseases
Stomatognathic Diseases
Facial Pain