drugset / Trial / NCT01172405

Efficacy and Safety Study to Compare Ibuprofen + Caffeine With Ibuprofen Alone in the Treatment of Headache

NCT01172405

RandomizedParallel-groupTriple-blindTreatment

Summary

Based on established therapeutic effect of ibuprofen in the treatment of headache attacks, and the action of caffeine in promoting better results when combined with treatments of first choice in the treatment of headache, this study is designed to: * evaluate the efficacy of therapy with ibuprofen + caffeine in headache patients compared to ibuprofen alone; * evaluate the tolerability of the association ibuprofen + caffeine compared to ibuprofen alone. The hypothesis is that the association is superior to treatment with ibuprofen alone in terms of efficacy, while maintaining good tolerability.

Timeline

Start
2010-10
Primary completion
2012-10
Completion
2012-10

Drugs

EvaluationDrugModalityDoseRoute
Subject Caffeine Small molecule 200 mg
Subject Ibuprofen Small molecule 400 mg

Indications