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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

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)

View Results

Links

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

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