A Multi-center, Randomized, Double-blind, Parallel-group Single-dose, Placebo-controlled Study Comparing the Efficacy and Safety of Acetaminophen, Aspirin and Caffeine With Sumatriptan in the Acute Treatment of Migraine.

NCT01248468 Phase 4 COMPLETED Results posted

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.

Details

Lead sponsor	Novartis
Phase	Phase 4
Status	COMPLETED
Enrolment	752
Start date	2010-11
Completion	2011-03

Conditions

• Pain, Migraine

Interventions

• Aspirin, acetaminophen and caffeine
• Sumatriptan
• Placebo

Primary outcomes

• Percent of Subjects Who Are Pain Free at 2 Hours. — 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

Countries

United States