Efficacy Of PF-05089771 In Treating Postoperative Dental Pain
Condition: Postoperative Dental Pain
MeSH terms: Toothache
Intervention: PF-05089771; Placebo; PF-05089771; Placebo; PF-05089771; Placebo; Ibuprofen; Placebo; Placebo; Placebo
Intervention description: A single dose of PF-05089771 1600 mg oral solution administered once to the subject on Day 1 postoperatively; Placebo tablets for ibuprofen: 2 X 200 mg placebo tablets administered orally once to the subject on Day 1 postoperatively; A single dose of PF-05089771 450 mg oral solution administered once to the subject on Day 1 postoperatively; Placebo tablets for ibuprofen: 2 X 200 mg placebo tablets administered orally once to the subject on Day 1 postoperatively; A single dose of PF-05089771 150 mg oral solution administered once to the subject on Day 1 postoperatively; Placebo tablets for ibuprofen: 2 X 200 mg placebo tablets administered orally once to the subject on Day 1 postoperatively; 2 X 200 mg tablets of ibuprofen administered orally once to the subject on Day 1 postoperatively; Placebo solution for PF-05089771: A single dose of Placebo solution administered once to the subject on Day 1 postoperatively; Placebo solution for PF-05089771:A single dose of Placebo solution administered once to the subject on Day 1 postoperatively; Placebo tablets for Ibuprofen: 2 X 200 mg placebo tablets administered orally once to the subject on Day 1 postoperatively
Intervention MeSH terms: Ibuprofen
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 235.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: No
Keywords: Postoperative dental pain

Summary:

      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.
    

Eligibility criteria:

        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.