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