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
Summary
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.
Description
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
Conditions
Treatment of Episodic Tension Headache
Intervention
Association: acetylsalicylic acid (500mg), sodium bicarbonate (1625) and citric acid (965), Aspirin - Bayer
Location
Lal Clinica Pesquisa E Desenvolvimento Ltda
Valinhos
SP
Brazil
13270000
Status
Not yet recruiting
Source
L.A.L Clinica Pesquisa e Desenvolvimento Ltda.
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT01012349
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Sodium-bicarbonate Symporters
Proteins that cotransport sodium ions and bicarbonate ions across cellular membranes.
Citric Acid
A key intermediate in metabolism. It is an acid compound found in citrus fruits. The salts of citric acid (citrates) can be used as anticoagulants due to their calcium chelating ability.
Chloride-bicarbonate Antiporters
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.
Fumarate Hydratase
An enzyme that catalyzes the reversible hydration of fumaric acid to yield L-malic acid. It is one of the citric acid cycle enzymes. EC 4.2.1.2.
Oxaloacetic Acids
A class of ketodicarboxylic acids derived from oxalic acid. Oxaloacetic acid is an intermediate in the citric acid cycle and is converted to ASPARTIC ACID by a transamination reaction.
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