drugset / Trial / NCT01172405
Efficacy and Safety Study to Compare Ibuprofen + Caffeine With Ibuprofen Alone in the Treatment of Headache
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Caffeine | Small molecule | 200 mg | — |
| Subject | Ibuprofen | Small molecule | 400 mg | — |