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

Study Overview
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Brief Summary
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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.

Official Title
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A Multicentre Randomised Parallel-groups Double-blind Double-dummy Single-dose Study to Compare Acetylsalicylic Acid 500 mg and 1,000 mg With Ibuprofen 200 mg and 400 mg and Placebo for Tolerability and Efficacy in the Treatment of Episodic Tension-type Headache

Conditions
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Headache, Tension-Type Headache, Tension-Type Headache (Episodic)

Intervention / Treatment
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* Drug: Acetylsalicylic acid (Aspirin, BAYE4465)
* Drug: Acetylsalicylic acid (Aspirin, BAYE4465)
* Drug: Ibuprofen
* Drug: Ibuprofen
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Arm 1<br> | Drug: Acetylsalicylic acid (Aspirin, BAYE4465)<br>* Acetylsalicylic acid 500 mg orally, single dose, 1 tablet; in addition, 1 Placebo tablet of Acetylsalicylic acid, and 2 Placebo tablets of Ibuprofen<br>|
| Experimental: Arm 2<br> | Drug: Acetylsalicylic acid (Aspirin, BAYE4465)<br>* Acetylsalicylic acid 2 x 500 mg orally, single dose, 2 tablets; in addition, 2 Placebo tablets of Ibuprofen<br>|
| Active Comparator: Arm 3<br> | Drug: Ibuprofen<br>* Ibuprofen 200 mg orally, single dose, 1 tablet; in addition, 1 Placebo tablet of Ibuprofen, and 2 Placebo tablets of Acetylsalicylic Acid<br>|
| Active Comparator: Arm 4<br> | Drug: Ibuprofen<br>* Ibuprofen 2 x 200 mg orally, single dose, 2 tablets; in addition, 2 Placebo tablets of Acetylsalicylic Acid<br>|
| Placebo Comparator: Arm 5<br> | Drug: Placebo<br>* 2 Placebo tablets of Acetylsalicylic Acid, and 2 Placebo tablets of Ibuprofen, orally, single dose<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of subjects with total or meaningful headache relief at 2 hours after intake of study medication |  | 2 hours post dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Headache pain relief measured serially on a categorical scale |  | Until 4 hours post dose | 
| Measuring the functional ability on conducting everydays activity on a 4 point categorical scale |  | 2 and 24 hours post dose | 
| Global assessment of pain therapy |  | 24 hours post dose | 
| Safety - assessment of adverse events |  | Up to 10 weeks after screening |