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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00387140
First received: October 9, 2006
Last updated: November 12, 2014
Last verified: November 2014
  Purpose

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 Intervention Phase
Pain, Postoperative
Tooth Extraction
Drug: MK2295
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Peak analgesic response, safety, and tolerability [ Time Frame: Over 24 Hours ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Onset of analgesia, duration of analgesia [ Time Frame: Over 24 Hours ] [ Designated as safety issue: No ]

Enrollment: 89
Study Start Date: October 2006
Study Completion Date: May 2007
Primary Completion Date: May 2007 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: MK2295
    Other Name: MK2295
  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00387140

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

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00387140     History of Changes
Other Study ID Numbers: 2295-005, MK2295-005, 2006_518
Study First Received: October 9, 2006
Last Updated: November 12, 2014
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Pain, Postoperative
Toothache
Facial Pain
Pain
Pathologic Processes
Postoperative Complications
Signs and Symptoms
Stomatognathic Diseases
Tooth Diseases

ClinicalTrials.gov processed this record on November 25, 2014