Conditions: Pain, Migraine
Keywords: Pain, Migraine
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 752
Healthy volunteers: no

Brief summary:
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.

Detailed description:

Arms:
arm 1: AAC: 2 tablets, each containing acetaminophen 250 mg, aspiring 250 mg, caffeine 65 mg and 1 placebo tablet matching sumatriptan 100 mg tablets arm 2: 1 tablet containing sumatriptan 100 mg and 2 placebo tablets matching acetaminophen 250 mg, aspirin 250 mg and caffeine 65 mg tablets arm 3: 1 placebo tablet matching sumatriptan 100mg and 2 placebo tablets matching acetaminophen 250 mg, aspirin 250 mg and caffeine 65 mg tablets

Interventions: intervention 1: Aspirin, acetaminophen and caffeine intervention 2: Sumatriptan intervention 3: Placebo
Intervention descriptions: intervention 1: 2 tablets each containing Aspirin (250mg), acetaminophen (250mg) and caffeine (65mg) intervention 2: 100 mg Sumatriptan intervention 3: placebo

Protocol document: