Efficacy Of PF-05089771 In Treating Postoperative Dental Pain

• Drug: PF-05089771
  A single dose of PF-05089771 1600 mg oral solution administered once to the subject on Day 1 postoperatively
• Other: Placebo
  Placebo tablets for ibuprofen: 2 X 200 mg placebo tablets administered orally once to the subject on Day 1 postoperatively
• Drug: PF-05089771
  A single dose of PF-05089771 450 mg oral solution administered once to the subject on Day 1 postoperatively
• Drug: PF-05089771
  A single dose of PF-05089771 150 mg oral solution administered once to the subject on Day 1 postoperatively
• Drug: Ibuprofen
  2 X 200 mg tablets of ibuprofen administered orally once to the subject on Day 1 postoperatively
• Other: Placebo
  Placebo solution for PF-05089771: A single dose of Placebo solution administered once to the subject on Day 1 postoperatively
• Other: Placebo
  Placebo solution for PF-05089771:A single dose of Placebo solution administered once to the subject on Day 1 postoperatively
• Other: Placebo
  Placebo tablets for Ibuprofen: 2 X 200 mg placebo tablets administered orally once to the subject on Day 1 postoperatively

• Experimental: PF-05089771 1600 mg
  Interventions:

  • Drug: PF-05089771
  • Other: Placebo
• Experimental: PF-05089771 450 mg
  Interventions:

  • Drug: PF-05089771
  • Other: Placebo
• Experimental: PF-05089771 150 mg
  Interventions:

  • Drug: PF-05089771
  • Other: Placebo
• Active Comparator: Ibuprofen 400 mg
  Interventions:

  • Drug: Ibuprofen
  • Other: Placebo
• Placebo Comparator: Placebo
  Interventions:

  • Other: Placebo
  • Other: Placebo

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.