NCT01172405

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

A Clinical Multicenter, Phase III, Randomized, Double-blind, Prospective and Comparative Trial to Evaluate the Efficacy and Safety of the Combination of Ibuprofen + Caffeine in the Treatment of Headache Attacks, Compared to Ibuprofen Alone.

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 144 (estimated)
• Sponsor: Mantecorp Industria Quimica e Farmaceutica Ltd. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Headache

Interventions

Type	Name	Description
DRUG	Ibuprofen plus caffeine	One or two tablets of ibuprofen 400 mg + caffeine 200 mg when presenting headache.
DRUG	Ibuprofen	One or two tablets of ibuprofen 400 mg when presenting headache.

Timeline

• Start date: 2010-10-01
• Primary completion: 2012-10-01
• Completion: 2012-10-01
• First posted: 2010-07-29
• Last updated: 2010-07-29