Efficacy Of PF-05089771 In Treating Postoperative Dental Pain

A Randomized, Double-blind, Double-dummy, Parallel Group, Placebo Controlled Study Assessing The Efficacy Of Single Doses Of Pf-05089771 For The Treatment Of Postoperative Dental Pain Using Ibuprofen 400 Mg As Positive Control

The objective of this study is to evaluate the overall pain relief of a single dose of PF-05089771 against placebo following third molar extraction.

Inclusion Criteria:

• Oral surgery having removed 2 unilateral third molar teeth.
• Pre-dose pain intensity score (100 mm VAS [VAS]) of at least 50mm within 5 hours of oral surgery
• Pre-dose pain intensity score of moderate or severe within 5 hours of oral surgery

Exclusion Criteria:

• Presence or known history of any clinically significant hematological, hepatic, renal, endocrine, cardiovascular, neurological, psychiatric, gastrointestinal, pulmonary, allergic (including known drug hypersensitivities or allergies, but excluding untreated asymptomatic seasonal allergy) or any metabolic disorder that may increase risk associated with study participation, investigational drug administration or may interfere with interpretation of study results.
• Prior use of any type of analgesic or NSAID within 5-half lives of that drug or less before taking the first dose of study medication, except for anesthesia for the procedure.
• Active dental infection at the time of surgery.
• Recent (within the previous 12 months) history of chronic analgesic or tranquiliser dependency.
• Any significant oral surgery complication at the time of surgery or in the immediate postoperative period, or oral surgery that has lasted more than 30 minutes (time from first incision to last suture placement).

Subjects who smoke more than 1 pack (20 cigarettes) per day, more than 3 cigars per day or use smokeless tobacco on a daily basis are excluded from the study.