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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
1,115
Acetylsalicylic acid 500 mg orally, single dose, 1 tablet; in addition, 1 Placebo tablet of Acetylsalicylic acid, and 2 Placebo tablets of Ibuprofen
Acetylsalicylic acid 2 x 500 mg orally, single dose, 2 tablets; in addition, 2 Placebo tablets of Ibuprofen
Ibuprofen 200 mg orally, single dose, 1 tablet; in addition, 1 Placebo tablet of Ibuprofen, and 2 Placebo tablets of Acetylsalicylic Acid
Ibuprofen 2 x 200 mg orally, single dose, 2 tablets; in addition, 2 Placebo tablets of Acetylsalicylic Acid
2 Placebo tablets of Acetylsalicylic Acid, and 2 Placebo tablets of Ibuprofen, orally, single dose
Unnamed facility
Reading, Berkshire, United Kingdom
Unnamed facility
Manchester, Greater Manchester, United Kingdom
Unnamed facility
Chorley, Lancashire, United Kingdom
Unnamed facility
Wigan, Lancashire, United Kingdom
Unnamed facility
Liverpool, Merseyside, United Kingdom
Unnamed facility
Liverpool, Merseyside, United Kingdom
Unnamed facility
Cardiff, South Glamorgan, United Kingdom
Unnamed facility
Glasgow, Strathclyde, United Kingdom
Unnamed facility
Birmingham, West Midlands, United Kingdom
Unnamed facility
Coventry, West Midlands, United Kingdom
...and 1 more locations
Percentage of subjects with total or meaningful headache relief at 2 hours after intake of study medication
Time frame: 2 hours post dose
Headache pain relief measured serially on a categorical scale
Time frame: Until 4 hours post dose
Measuring the functional ability on conducting everydays activity on a 4 point categorical scale
Time frame: 2 and 24 hours post dose
Global assessment of pain therapy
Time frame: 24 hours post dose
Safety - assessment of adverse events
Time frame: Up to 10 weeks after screening
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.