Study Evaluating A Novel Ibuprofen Formulation In The Treatment Of Dental Pain

• Drug: Novel Ibuprofen
  
  Single-dose of novel ibuprofen (equal to 400 mg ibuprofen)
• Drug: Standard Ibuprofen
  
  Single-dose of standard ibuprofen (400mg)
• Drug: Placebo
  
  Single-dose of placebo

• Experimental: Treatment A
  
  Intervention: Drug: Novel Ibuprofen
• Active Comparator: Treatment B
  
  Intervention: Drug: Standard Ibuprofen
• Active Comparator: Treatment C
  
  Intervention: Drug: Standard Ibuprofen
• Placebo Comparator: Treatment D
  
  Intervention: Drug: Placebo

Inclusion Criteria:

• Normal, healthy males and females 16 to 40 years of age
• Outpatients who have moderate to severe post-operative pain (confirmed by a Visual Analog Scale-Pain Severity Rating [VAS-PSR] score of at least 50 mm on a 100 mm VAS-PSR) following surgical extraction of two or more third molars, at least one of which must be a partial or complete bony mandibular impaction
• Use of only the following pre-operative medication(s)/anesthetic(s): topical benzocaine, a short acting parenteral (local) anesthetic (mepivacaine or lidocaine) with or without vasoconstrictor and/or nitrous oxide

Exclusion Criteria:

• Pregnancy or breast-feeding
• Alcohol or substance abuse
• Any serious medical or psychiatric disorder
• History of stomach ulcers, stomach bleed, or other bleeding disorders
• Use of a prescription or over-the-counter drug with which administration of ibuprofen or any other non-steroidal anti-inflammatory drug, acetaminophen, or hydrocodone is contraindicated (including: opioids, antipsychotics, antianxiety agents, or other central nervous system depressants[including alcohol])