Placebo and Active Controlled, Double Dummy Study to Compare Efficacy of Aspirin and Ibuprofen in Treatment of Episodic Tension-type Headache
Placebo and Active Controlled, Double Dummy Study to Compare Efficacy of Aspirin and Ibuprofen in Treatment of Episodic Tension-type Headache
The purpose of this study is to determine the efficacy and tolerability of 500 mg and 1000 mg
 Aspirin® (study medication) by comparing it to placebo (the control group without active
 substance) or 200 mg or 400 mg Ibuprofen (study medication) in treating the symptoms of
 episodic tension-type headache. The study is designed to develop a treatment method against
 episodic tension-type headache which will have more advantages for patients than the methods
 that are currently available.
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