Back to resultsA Study to Evaluate the Efficacy of MK0719 in the Prevention of Postoperative Dental Pain (0719-002)
Primary Purpose
Pain, Postoperative
Status
Terminated
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
MK0719
Sponsored by
About this trial
This is an interventional prevention trial for Pain, Postoperative focused on measuring Postoperative Dental Pain
Eligibility Criteria
Inclusion Criteria :
- Patients in generally good health who are scheduled to have 2 or more third molars removed, at least 1 of which is partially or completely embedded in bone and is a mandibular impaction
Exclusion Criteria :
- Patient has a history of any illness or condition that, in the opinion of the investigator, might confound the results of the study or pose additional risk to the patient
Sites / Locations
Outcomes
Primary Outcome Measures
Proprietary Information - Exploratory (Non-Confirmatory) Trial
Secondary Outcome Measures
Proprietary Information - Exploratory (Non-Confirmatory) Trial
Full Information
NCT ID
NCT00424424
First Posted
January 18, 2007
Last Updated
October 30, 2015
Sponsor
Merck Sharp & Dohme LLC
1. Study Identification
Unique Protocol Identification Number
NCT00424424
Brief Title
A Study to Evaluate the Efficacy of MK0719 in the Prevention of Postoperative Dental Pain (0719-002)
Official Title
Proprietary Information - Exploratory (Non-Confirmatory) Trial
Study Type
Interventional
2. Study Status
Record Verification Date
October 2015
Overall Recruitment Status
Terminated
Study Start Date
August 2006 (undefined)
Primary Completion Date
January 2007 (Actual)
Study Completion Date
January 2007 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Merck Sharp & Dohme LLC
4. Oversight
5. Study Description
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 prevention of postoperative dental pain in male patients.
This is an early phase trial and some specific protocol information is proprietary and not publicly available at this time. (Full information is available to trial participants).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative
Keywords
Postoperative Dental Pain
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
Double
Allocation
Randomized
Enrollment
81 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
MK0719
Primary Outcome Measure Information:
Title
Proprietary Information - Exploratory (Non-Confirmatory) Trial
Secondary Outcome Measure Information:
Title
Proprietary Information - Exploratory (Non-Confirmatory) Trial
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria :
Patients in generally good health who are scheduled to have 2 or more third molars removed, at least 1 of which is partially or completely embedded in bone and is a mandibular impaction
Exclusion Criteria :
Patient has a history of any illness or condition that, in the opinion of the investigator, might confound the results of the study or pose additional risk to the patient
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Monitor
Organizational Affiliation
Merck Sharp & Dohme LLC
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
A Study to Evaluate the Efficacy of MK0719 in the Prevention of Postoperative Dental Pain (0719-002)
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