Placebo and Active Controlled, Double Dummy Study to Compare Efficacy of Aspirin and Ibuprofen in Treatment of Episodic Tension-type Headache

Inclusion criteria

• Ambulatory male or female, 18 to 65 years of age
• Normal blood pressure
• Patients suffering from episodic tension-type headache
• Headache lasting from 30 minutes to 7 days
• Headache had at least two of the following characteristics:

Bilateral location. Pressing/tightening (non-pulsating). Mild or moderate intensity. Not aggravated by routine physical activity such as walking or climbing stairs.

• Both of the following: No nausea or vomiting. No more than one of photophobia or phonophobia.

Exclusion criteria

• Other headaches, including migraine, that required medical treatment
• Hypersensitivity to acetylsalicylic acid, salicylates, ibuprofen or other non-steroidal anti-inflammatory drugs (NSAIDs)
• Serious physical illness especially uncontrolled disorders of kidney, liver, lung, heart or brain function, neurological disorders or severe chronic or terminal disease
• Mental illness, including depression
• Needed or were using or likely to need or use any of the prohibited concomitant medications: antidepressants, oxicams
• Pregnant or lactating women, or sexually active women of child-bearing potential unless using effective contraception
• Participating in any other clinical study or had done within the previous 4 weeks
• Had been previously enrolled in this study