Efficacy and Safety Study to Compare Ibuprofen + Caffeine With Ibuprofen Alone in the Treatment of Headache
Recruitment status was: Not yet recruiting
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
|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.|
- Efficacy of study treatment compared with control to relieve headache symptoms. [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]The evaluation of efficacy will be determined based on comparison of the intensity of headache before and after initiation of treatment, using the Functional Disabling Scale. The opinion of the investigator will be established based on the Likert scale and duration of symptoms after the treatment will be checked as a measure of comparison between treatments in the study.
- Tolerability of study treatment compared with control to relieve headache symptoms. [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]Tolerability will be assessed by the investigator through the number of adverse events definitely related to study medication. This relationship will be defined by applying the Naranjo algorithm.
|Study Start Date:||October 2010|
|Estimated Study Completion Date:||October 2012|
|Estimated Primary Completion Date:||October 2012 (Final data collection date for primary outcome measure)|
Experimental: Ibuprofen + Caffeine
72 patients treated with one or two tablets of ibuprofen 400 mg + caffeine 200 mg when presenting headache.
Drug: Ibuprofen plus caffeine
One or two tablets of ibuprofen 400 mg + caffeine 200 mg when presenting headache.
Active Comparator: Ibuprofen
72 patients treated with one or two tablets of ibuprofen 400 mg when presenting headache.
One or two tablets of ibuprofen 400 mg when presenting headache.
Other Name: DALSY
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