Efficacy Of Pf-04531083 In Treating Post-Surgical Dental Pain

• Drug: PF-04531083
  2000 mg oral solution
• Other: Placebo
  Placebo tablets for Ibuprofen
• Drug: PF-04531083
  1000 mg oral solution
• Drug: Ibuprofen
  2 x 200 mg tablets
• Other: Placebo
  Placebo solution for PF-04531083

• Experimental: PF-04531083 2000 mg
  Interventions:

  • Drug: PF-04531083
  • Other: Placebo
• Experimental: PF-04531083 1000 mg
  Interventions:

  • Drug: PF-04531083
  • Other: Placebo
• Active Comparator: Ibuprofen 400 mg
  Interventions:

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

  • Other: Placebo
  • Other: Placebo

Inclusion Criteria:

• 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 Criteria:

• 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.