A Study to Evaluate the Safety and Efficacy of an Investigational Drug in the Treatment of Postoperative Dental Pain
This study has been completed.
Information provided by:
Merck Sharp & Dohme Corp.
First received: October 9, 2006
Last updated: May 15, 2008
Last verified: May 2008
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.
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
||A Randomized Double-Blind, Placebo-and Active Comparator-Controlled 2-Part Study to Evaluate the Efficacy of MK2295 in Patients With Postoperative Dental Pain
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 ]
| Study Start Date:
| Primary Completion Date:
||December 2007 (Final data collection date for primary outcome measure)
Other Name: MK2295
|Ages Eligible for Study:
||18 Years to 45 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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
- Patient has a temperature of 37.5C or greater prior to dosing
- Patient has participated in another clinical study within the last 4 weeks
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
Merck Sharp & Dohme Corp.
||Merck Sharp & Dohme Corp.
No publications provided
||Executive Vice President, Clinical and Quantitative Sciences, Merck & Co., Inc.
History of Changes
|Other Study ID Numbers:
|Study First Received:
||October 9, 2006
||May 15, 2008
||United States: Food and Drug Administration
Keywords provided by Merck Sharp & Dohme Corp.:
Dental Pain, Postoperative
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on October 21, 2014
Signs and Symptoms