Headache, Tension-Type Headache, Tension-Type Headache (Episodic)
Conditions
Brief summary
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.
Interventions
Acetylsalicylic acid 500 mg orally, single dose, 1 tablet; in addition, 1 Placebo tablet of Acetylsalicylic acid, and 2 Placebo tablets of Ibuprofen
DRUGIbuprofen
Ibuprofen 200 mg orally, single dose, 1 tablet; in addition, 1 Placebo tablet of Ibuprofen, and 2 Placebo tablets of Acetylsalicylic Acid
DRUGPlacebo
2 Placebo tablets of Acetylsalicylic Acid, and 2 Placebo tablets of Ibuprofen, orally, single dose
Sponsors
Bayer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of subjects with total or meaningful headache relief at 2 hours after intake of study medication | 2 hours post dose |
Secondary
| Measure | 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 |
Countries
United Kingdom
Outcome results
None listed