Status:
TERMINATED
Efficacy Of Pf-04531083 In Treating Post-Surgical Dental Pain
Lead Sponsor:
Pfizer
Conditions:
Post-surgical Dental Pain
Eligibility:
MALE
18-55 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to evaluate the overall pain relief of a single dose of PF-04531083 against placebo following third molar extraction.
Eligibility Criteria
Inclusion
- Oral surgical procedure having removed 2 third molars (unilateral).
- Pre-dose pain intensity score (100 mm Visual Analog Scale \[VAS\]) \>50 mm within 5 hours of oral surgery.
- Pre-dose pain intensity score of moderate or within 5 hours of oral surgery.
Exclusion
- Presence or history of any significant hepatic, renal, endocrine, cardiovascular, neurological (including subjects with a history of frequent moderate to severe headaches or subjects with episodic migraines more than twice per month), psychiatric, gastrointestinal, pulmonary, hematologic, or metabolic disorder.
- Prior use of any type of analgesic or NSAID within five half-lives of that drug or less before taking the first dose of study medication, except for anesthesia for the procedure.
- Recent history of chronic analgesic or tranquilizer dependency.
- Active dental infection at the time of surgery.
- Any significant oral surgery complication at the time of surgery or in the immediate postoperative period or dental surgery lasting \> 30 minutes.
- Subjects who are smokers.
Key Trial Info
Start Date :
October 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2012
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT01512160
Start Date
October 1 2011
End Date
May 1 2012
Last Update
June 28 2013
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Pfizer Investigational Site
Austin, Texas, United States, 78744