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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.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01012349
Recruitment Status : Unknown
Verified October 2010 by Azidus Brasil.
Recruitment status was:  Not yet recruiting
First Posted : November 13, 2009
Last Update Posted : January 28, 2011
Information provided by:
Azidus Brasil

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.

Condition or disease Intervention/treatment Phase
Treatment of Episodic Tension Headache Drug: Association: acetylsalicylic acid (500mg), sodium bicarbonate (1625) and citric acid (965) Drug: Aspirin - Bayer Phase 2 Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 152 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : February 2011
Estimated Primary Completion Date : May 2011
Estimated Study Completion Date : August 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Headache

Arm Intervention/treatment
Experimental: Test
Administration of GeoLab Association (acetylsalicylic acid, sodium bicarbonate and citric acid)
Drug: Association: acetylsalicylic acid (500mg), sodium bicarbonate (1625) and citric acid (965)
1 tablet in an episody of headache

Active Comparator: Comparator
Acetylsalicylic acid - (Aspirin - Bayer)
Drug: Aspirin - Bayer
1 tablet in an episody of headache (Aspirin 500mg)

Primary Outcome Measures :
  1. The primary efficacy endpoint is the rate of sustained response (percentage of subjects who have no pain) two hours after the drug administration. [ Time Frame: 0, 30, 60, 90 and 120 minutes ]

Secondary Outcome Measures :
  1. • Reduction of associated symptoms (photophobia, phonophobia, nausea, vomiting); • Symptoms stomach before and after treatment • Change in gastric pH after administration; • Incidence of administration of rescue medications; • Change in pain [ Time Frame: 30, 60, 90 and 120 minutes after administration ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01012349

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Contact: alexandre Frederico, physician 55 19 3829-3822

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Lal Clinica Pesquisa E Desenvolvimento Ltda Not yet recruiting
Valinhos, SP, Brazil, 13270000
Contact: Alexandre Frederico, Physician    55 19 3829-3822   
Sponsors and Collaborators
Azidus Brasil

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Responsible Party: Alexandre Frederico, LAL Clinica Pesquisa e Desenvolvimento Ltda Identifier: NCT01012349     History of Changes
Other Study ID Numbers: AASGEO0809
Version 2
First Posted: November 13, 2009    Key Record Dates
Last Update Posted: January 28, 2011
Last Verified: October 2010

Additional relevant MeSH terms:
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Tension-Type Headache
Neurologic Manifestations
Signs and Symptoms
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Sodium Citrate
Citric Acid
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Calcium Chelating Agents