A Phase 4 interventional study of Acetylsalicylic acid (Aspirin, BAYE4465) and Acetylsalicylic acid (Aspirin, BAYE4465) in Headache, Tension-Type Headache and Tension-Type Headache (Episodic), sponsored by Bayer. Completed at 11 sites in United Kingdom. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2014-12-25.
Sponsored by Bayer · Phase 4, Interventional, and Treatment
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.
144 studies on the registry are indexed under Tension-Type Headache; 41 are open to participants now.
This study's enrollment of 1,115 is above the median of 60 across 109 interventional studies indexed under Tension-Type Headache.
Browse Tension-Type Headache studies →Bayer is the lead sponsor of 1,643 studies on the registry; 57 are open to participants now.
Of its 209 completed or terminated interventional studies of FDA-regulated products, 129 (62%) have results posted.
Counted across the registry records on this site, refreshed daily.
Bilateral location. Pressing/tightening (non-pulsating). Mild or moderate intensity. Not aggravated by routine physical activity such as walking or climbing stairs.
Exclusion Criteria:
Drug: Acetylsalicylic acid (Aspirin, BAYE4465)
Drug: Acetylsalicylic acid (Aspirin, BAYE4465)
Drug: Ibuprofen
Drug: Ibuprofen
Drug: Placebo
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
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 study is completed, as verified in Dec 2014. You cannot join it, but the record below documents what was studied.
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