Study Evaluating A Novel Ibuprofen Formulation In Episodic Tension-Type Headache

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

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

Inclusion Criteria:

• Males and females at least 18 years to 65 years of age
• A diagnosis of an episodic tension-type headache, as defined by the International Headache Society
• A history of episodic tension-type headache with the following characteristics: 4 headache episodes per month for the last 6 months of moderately severe intensity; headache generally lasts more than 3 hours if left untreated; adequate headache relief is generally obtained with over-the-counter (OTC) doses of OTC analgesics

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