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

Headache Clinical Trial

Official title:
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.

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01172405
Study type Interventional
Source Mantecorp Industria Quimica e Farmaceutica Ltd.
Contact Claudia Domingues
Phone +551151885237
Email cdomingues@mantecorp.com
Status Not yet recruiting
Phase Phase 3
Start date October 2010
Completion date October 2012
View Details
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