Efficacy and Safety Clinical Trial of the Combination of Acetylsalicylic Acid, Sodium Bicarbonate and Citric Acid, Produced by Geolab Pharmaceutical Industries Ltd., Compared to Acetylsalicylic Acid (Aspirin ® - Bayer) in Patients With Episodic Tension-t

2014-08-27 03:18:02 | BioPortfolio


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:

- Modification of gastric pH after administration of drugs by measuring with gastroesophageal pH Monitor, comparing the results between the groups;

- The incidence of administration of rescue medications, through the accounts of patients and researchers, comparing the results between the groups;

- The percentage of improvement in time 30, 60, 90 and 120 minutes after administration, using the visual analog scale (VAS), comparing the results between the groups;

- Evaluate the gastric symptoms before and after treatment by clinical investigation of patients, comparing the results between the groups;

- Evaluate the change in associated symptoms (photophobia, phonophobia, nausea, vomiting), using 4-point scale (0 - absent 1 - mild 2 - moderate 3 - severe), comparing the results between the groups;

- Assess the quantitative and qualitative parameters related to adverse reactions, comparing the results between the groups.

Study Design

Allocation: Randomized, Control: Active Control, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Treatment of Episodic Tension Headache


Association: acetylsalicylic acid (500mg), sodium bicarbonate (1625) and citric acid (965), Aspirin - Bayer


Lal Clinica Pesquisa E Desenvolvimento Ltda


Not yet recruiting


L.A.L Clinica Pesquisa e Desenvolvimento Ltda.

Results (where available)

View Results


Published on BioPortfolio: 2014-08-27T03:18:02-0400

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Medical and Biotech [MESH] Definitions

Bicarbonate transporters that move BICARBONATE IONS in exchange of CHLORIDE IONS or SODIUM IONS across membranes. They regulate acid-base HOMEOSTASIS, cell volume and intracellular pH. Members include CHLORIDE-BICARBONATE ANTIPORTERS (SLC4A1, 2, 3, and 9); SODIUM-COUPLED BICARBONATE TRANSPORTERS (SLC4A4 and 5, 7, 8 and 10); and a sodium borate cotransporter (SLC4A11 protein).

Proteins that cotransport sodium ions and bicarbonate ions across cellular membranes.

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Membrane proteins that allow the exchange of chloride ions for bicarbonate ions across the cellular membrane. The action of specific antiporters in this class serve important functions such as allowing the efficient exchange of bicarbonate across red blood cell membranes as they passage through capillaries and the reabsorption of bicarbonate ions by the kidney.

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