- 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
- Pre-dose pain intensity score of moderate or severe within 5 hours of oral surgery
- 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
- Active dental infection at the time of surgery.
- Recent (within the previous 12 months) history of chronic analgesic or tranquiliser
- 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.