drugset / Trial / 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.

NCT01012349

Phase 2/3 Unknown 152 enrolled Azidus Brasil
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2011-02
Primary completion
2011-05
Completion
2011-08

Drugs

EvaluationDrugModalityDoseRoute
Subject Aspirin Small molecule 500 mg Oral
Subject citric acid Unknown 965 unknown Oral
Subject sodium bicarbonate Diagnostic / imaging agent 1625 unknown Oral

Indications

No indication recorded.