Back to resultsA Study to Evaluate the Safety and Efficacy of an Investigational Drug in the Treatment of Postoperative Dental Pain (MK-2295-005)
Primary Purpose
Pain, Postoperative, Tooth Extraction
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
MK2295
Sponsored by
About this trial
This is an interventional treatment trial for Pain, Postoperative focused on measuring Dental Pain, Postoperative
Eligibility 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
Sites / Locations
Outcomes
Primary Outcome Measures
Peak analgesic response, safety, and tolerability
Secondary Outcome Measures
Onset of analgesia, duration of analgesia
Full Information
NCT ID
NCT00387140
First Posted
October 9, 2006
Last Updated
October 30, 2015
Sponsor
Merck Sharp & Dohme LLC
1. Study Identification
Unique Protocol Identification Number
NCT00387140
Brief Title
A Study to Evaluate the Safety and Efficacy of an Investigational Drug in the Treatment of Postoperative Dental Pain (MK-2295-005)
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 Type
Interventional
2. Study Status
Record Verification Date
October 2015
Overall Recruitment Status
Completed
Study Start Date
October 2006 (undefined)
Primary Completion Date
May 2007 (Actual)
Study Completion Date
May 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 treatment of postoperative dental pain in male patients.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative, Tooth Extraction
Keywords
Dental Pain, Postoperative
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
89 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
MK2295
Primary Outcome Measure Information:
Title
Peak analgesic response, safety, and tolerability
Time Frame
Over 24 Hours
Secondary Outcome Measure Information:
Title
Onset of analgesia, duration of analgesia
Time Frame
Over 24 Hours
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
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 Safety and Efficacy of an Investigational Drug in the Treatment of Postoperative Dental Pain (MK-2295-005)
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