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| ID | Type | Description | Link |
|---|---|---|---|
| Version 2 |
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This study aims is to evaluate, two hours after a single administration, the rate of sustained response produced by the association Geolab consisting of acetylsalicylic acid, sodium bicarbonate and anhydrous citric acid - oral powder, with the active comparator acetylsalicylic acid (Aspirin ® -- Bayer) - a simple tablet for the treatment of acute pain in patients with mild to moderate CTTE, using for both the visual analog scale pain - VAS.
The secondary objectives of the study are to evaluate:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test | Experimental | Administration of GeoLab Association (acetylsalicylic acid, sodium bicarbonate and citric acid) |
|
| Comparator | Active Comparator | Acetylsalicylic acid - (Aspirin - Bayer) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Association: acetylsalicylic acid (500mg), sodium bicarbonate (1625) and citric acid (965) | Drug | 1 tablet in an episody of headache |
|
| Measure | Description | Time Frame |
|---|---|---|
| The primary efficacy endpoint is the rate of sustained response (percentage of subjects who have no pain) two hours after the drug administration. | 0, 30, 60, 90 and 120 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| • Reduction of associated symptoms (photophobia, phonophobia, nausea, vomiting); • Symptoms stomach before and after treatment • Change in gastric pH after administration; • Incidence of administration of rescue medications; • Change in pain | 30, 60, 90 and 120 minutes after administration |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| alexandre Frederico, physician | Contact | 55 19 3829-3822 | dr.alexandre@alclinica.com.br |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lal Clinica Pesquisa E Desenvolvimento Ltda | Valinhos | São Paulo | 13270000 | Brazil |
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| Aspirin - Bayer | Drug | 1 tablet in an episody of headache (Aspirin 500mg) |
|
| ID | Term |
|---|---|
| D017693 | Sodium Bicarbonate |
| D019343 | Citric Acid |
| D001241 | Aspirin |
| ID | Term |
|---|---|
| D001639 | Bicarbonates |
| D002254 | Carbonates |
| D002255 | Carbonic Acid |
| D017554 | Carbon Compounds, Inorganic |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |
| D002951 | Citrates |
| D014233 | Tricarboxylic Acids |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D012459 | Salicylates |
| D062385 | Hydroxybenzoates |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
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