The main purpose of this study is to compare the efficacy and safety of aspirin, acetaminophen and caffeine (AAC) with sumatriptan and placebo in the acute treatment of migraine.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
752
2 tablets each containing Aspirin (250mg), acetaminophen (250mg) and caffeine (65mg)
100 mg Sumatriptan
placebo
Unnamed facility
Anaheim, California, United States
Unnamed facility
San Francisco, California, United States
Unnamed facility
Percent of Subjects Who Are Pain Free at 2 Hours.
Subjects assessed severity of pain on a 4 point scale (0=none, …, 3=severe) at set time points after dosing through 4 hours. Subjects who indicated severity of pain=none at 2 hours were considered pain free at 2 hours
Time frame: 2 hours
Percent of Subjects Who Are Free of Nausea at 2 Hours.
Subjects assessed severity of relevant symptom on a 4 point scale (0=none, …, 3=severe) at set time points after dosing through 4 hours. Subjects who indicated severity of relevant symptom=none at 2 hours were considered relevant symptom free at 2 hours
Time frame: 2 hours
Percent of Subjects Who Are Free of Phonophobia at 2 Hours.
Subjects assessed severity of relevant symptom on a 4 point scale (0=none, …, 3=severe) at set time points after dosing through 4 hours. Subjects who indicated severity of relevant symptom=none at 2 hours were considered relevant symptom free at 2 hours
Time frame: 2 hours
Percent of Subjects Who Are Free of Photophobia at 2 Hours.
Subjects assessed severity of relevant symptom on a 4 point scale (0=none, …, 3=severe) at set time points after dosing through 4 hours. Subjects who indicated severity of relevant symptom=none at 2 hours were considered relevant symptom free at 2 hours
Time frame: 2 hours
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Clearwater, Florida, United States
Unnamed facility
DeLand, Florida, United States
Unnamed facility
Jacksonville, Florida, United States
Unnamed facility
Miami, Florida, United States
Unnamed facility
Pembroke Pines, Florida, United States
Unnamed facility
West Palm Beach, Florida, United States
Unnamed facility
Chicago, Illinois, United States
Unnamed facility
Ann Arbor, Michigan, United States
...and 10 more locations