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 Ten

• Status: Unknown status
• Trial end date: 2011-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Azidus Brasil
• Treatments: Aspirin; Citric Acid; Sodium Citrate

Criteria

Inclusion Criteria:

• Agreed to participate in the study expressed by signing the two copies of the informed consent and informed consent (IC) after approved by the IRB;

• Minimum age of 18 years;

• Clinical history of TTH, according to the criteria of the International Classification of Headache of the International Headache Society, in face of crisis.

Exclusion Criteria:

• Headache, migraine

• Chronic Tension-Type Headache (CTTH)

• Altered mental status

• Vital signs changed

• established or suspected pregnancy and lactation

• History of allergy to components of study drugs

• Current treatment with methotrexate

• Current treatment with Antinauseants

• Current treatment with anticoagulants such as heparin or coumarin-derivative

• gastric or duodenal disorders, chronic or recurrent active

• Liver and kidney disease severe

• Use of medications that have drug interactions with AAS