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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:
The hypothesis is that the association is superior to treatment with ibuprofen alone in terms of efficacy, while maintaining good tolerability.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ibuprofen + Caffeine | Experimental | 72 patients treated with one or two tablets of ibuprofen 400 mg + caffeine 200 mg when presenting headache. |
|
| Ibuprofen | Active Comparator | 72 patients treated with one or two tablets of ibuprofen 400 mg when presenting headache. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ibuprofen plus caffeine | Drug | One or two tablets of ibuprofen 400 mg + caffeine 200 mg when presenting headache. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy of study treatment compared with control to relieve headache symptoms. | 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. | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Tolerability of study treatment compared with control to relieve headache symptoms. | 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. | 4 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Claudia Domingues | Contact | +551151885237 | cdomingues@mantecorp.com |
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| ID | Term |
|---|---|
| D006261 | Headache |
| D008881 | Migraine Disorders |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D007052 | Ibuprofen |
| D002110 | Caffeine |
| ID | Term |
|---|---|
| D010666 | Phenylpropionates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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| Ibuprofen | Drug | One or two tablets of ibuprofen 400 mg when presenting headache. |
|
|
| D051270 | Headache Disorders, Primary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014970 |
| Xanthines |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D011688 | Purinones |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |