Multiple Dose Dental Pain Study Of Ibuprofen Extended Release

A Multiple Dose Dental Pain Study Of An Ibuprofen 600 Mg Extended Release Caplet

The study hypothesis is that single and multiple doses of ibuprofen 600 mg ER caplets provide analgesic efficacy superior to placebo over 12-hour dosing intervals.

Inclusion Criteria:

• Males and females 16 to 40 years of age
• Subjects who undergo surgical removal of at least two third molars
• One of which must be a partial or full bony mandibular impaction
• Subjects must have at least moderate baseline pain (a score of 2 on the categorical pain severity rating scale) confirmed by a score of at least 50 mm on the 100-mm visual analog scale-pain severity rating scale (VAS-PSR)

Exclusion Criteria:

• Acute localized dental infection at the time of surgery that could confound the post-surgical evaluation
• Presence or history of any significant organ disease
• Use of prescription or OTC first generation antihistamines
• Females who are pregnant, lactating or of childbearing potential and not using a medically approved method to prevent pregnancy