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.

NCT ID: NCT01012349

Last Updated: 2011-01-28

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 152 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-02-28
• Study Completion Date: 2011-08-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Test

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

Group Type: EXPERIMENTAL

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

Intervention Type: DRUG

1 tablet in an episody of headache

Comparator

Acetylsalicylic acid - (Aspirin - Bayer)

Group Type: ACTIVE_COMPARATOR

Aspirin - Bayer

Intervention Type: DRUG

1 tablet in an episody of headache (Aspirin 500mg)

Interventions

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

1 tablet in an episody of headache

Intervention Type: DRUG

Aspirin - Bayer

1 tablet in an episody of headache (Aspirin 500mg)

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Azidus Brasil

INDUSTRY

Sponsor Role: lead

Responsible Party

LAL Clinica Pesquisa e Desenvolvimento Ltda

Locations

Lal Clinica Pesquisa E Desenvolvimento Ltda

Valinhos, São Paulo, Brazil

Countries

Brazil

Central Contacts

alexandre Frederico, physician

Role: CONTACT

dr.alexandre@alclinica.com.br

55 19 3829-3822

Facility Contacts

Alexandre Frederico, Physician

Role: primary

dr.alexandre@alclinica.com.br

55 19 3829-3822

Other Identifiers

Version 2

Identifier Type: -

Identifier Source: secondary_id

AASGEO0809

Identifier Type: -

Identifier Source: org_study_id