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.

Azidus

Status and phase: Unknown; Phase 3; Phase 2

Conditions: Treatment of Episodic Tension Headache

Treatments: Drug: Aspirin - Bayer; Drug: Association: acetylsalicylic acid (500mg), sodium bicarbonate (1625) and citric acid (965)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01012349

Version 2

AASGEO0809

Details and patient eligibility

About

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.

Full 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.

Enrollment: 152 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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152 participants in 2 patient groups

Test

Experimental group

Description:

Administration of GeoLab Association (acetylsalicylic acid, sodium bicarbonate and citric acid)

Treatment:

Drug: Association: acetylsalicylic acid (500mg), sodium bicarbonate (1625) and citric acid (965)

Comparator

Active Comparator group

Description:

Acetylsalicylic acid - (Aspirin - Bayer)

Treatment:

Drug: Aspirin - Bayer