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

• Headache pain relief measured serially on a categorical scale [ Time Frame: Until 4 hours post dose ] [ Designated as safety issue: No ]
• Measuring the functional ability on conducting everydays activity on a 4 point categorical scale [ Time Frame: 2 and 24 hours post dose ] [ Designated as safety issue: No ]
• Global assessment of pain therapy [ Time Frame: 24 hours post dose ] [ Designated as safety issue: No ]
• Safety - assessment of adverse events [ Time Frame: Up to 10 weeks after screening ] [ Designated as safety issue: Yes ]

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.

• Headache
• Tension-Type Headache
• Tension-Type Headache (Episodic)

• Drug: Acetylsalicylic acid (Aspirin, BAYE4465)
  Acetylsalicylic acid 500 mg orally, single dose, 1 tablet; in addition, 1 Placebo tablet of Acetylsalicylic acid, and 2 Placebo tablets of Ibuprofen
• Drug: Acetylsalicylic acid (Aspirin, BAYE4465)
  Acetylsalicylic acid 2 x 500 mg orally, single dose, 2 tablets; in addition, 2 Placebo tablets of Ibuprofen
• Drug: Ibuprofen
  Ibuprofen 200 mg orally, single dose, 1 tablet; in addition, 1 Placebo tablet of Ibuprofen, and 2 Placebo tablets of Acetylsalicylic Acid
• Drug: Ibuprofen
  Ibuprofen 2 x 200 mg orally, single dose, 2 tablets; in addition, 2 Placebo tablets of Acetylsalicylic Acid
• Drug: Placebo
  2 Placebo tablets of Acetylsalicylic Acid, and 2 Placebo tablets of Ibuprofen, orally, single dose

• Active Comparator: Arm 1
  Intervention: Drug: Acetylsalicylic acid (Aspirin, BAYE4465)
• Experimental: Arm 2
  Intervention: Drug: Acetylsalicylic acid (Aspirin, BAYE4465)
• Active Comparator: Arm 3
  Intervention: Drug: Ibuprofen
• Active Comparator: Arm 4
  Intervention: Drug: Ibuprofen
• Placebo Comparator: Arm 5
  Intervention: Drug: Placebo

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