NCT01012349

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-type Headache.

• Status: Unknown
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 152 (estimated)
• Sponsor: Azidus Brasil · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Treatment of Episodic Tension Headache

Interventions

Type	Name	Description
DRUG	Association: acetylsalicylic acid (500mg), sodium bicarbonate (1625) and citric acid (965)	1 tablet in an episody of headache
DRUG	Aspirin - Bayer	1 tablet in an episody of headache (Aspirin 500mg)

Timeline

• Start date: 2011-02-01
• Primary completion: 2011-05-01
• Completion: 2011-08-01
• First posted: 2009-11-13
• Last updated: 2011-01-28

Locations

1 site across 1 country: Brazil