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 recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2010 by L.A.L Clinica Pesquisa e Desenvolvimento Ltda..
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
L.A.L Clinica Pesquisa e Desenvolvimento Ltda.
ClinicalTrials.gov Identifier:
NCT01012349
First received: November 12, 2009
Last updated: January 27, 2011
Last verified: October 2010
  Purpose

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 Intervention 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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by L.A.L Clinica Pesquisa e Desenvolvimento Ltda.:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • • 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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 152
Study Start Date: February 2011
Estimated Study Completion Date: August 2011
Estimated Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01012349

Contacts
Contact: alexandre Frederico, physician 55 19 3829-3822 dr.alexandre@alclinica.com.br

Locations
Brazil
Lal Clinica Pesquisa E Desenvolvimento Ltda Not yet recruiting
Valinhos, SP, Brazil, 13270000
Contact: Alexandre Frederico, Physician    55 19 3829-3822    dr.alexandre@alclinica.com.br   
Sponsors and Collaborators
L.A.L Clinica Pesquisa e Desenvolvimento Ltda.
  More Information

No publications provided

Responsible Party: Alexandre Frederico, LAL Clinica Pesquisa e Desenvolvimento Ltda
ClinicalTrials.gov Identifier: NCT01012349     History of Changes
Other Study ID Numbers: AASGEO0809, Version 2
Study First Received: November 12, 2009
Last Updated: January 27, 2011
Health Authority: Brazil: National Health Surveillance Agency

Additional relevant MeSH terms:
Tension-Type Headache
Headache
Brain Diseases
Central Nervous System Diseases
Headache Disorders
Headache Disorders, Primary
Nervous System Diseases
Neurologic Manifestations
Pain
Signs and Symptoms
Aspirin
Citric Acid
Analgesics
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Anticoagulants
Antipyretics
Antirheumatic Agents
Cardiovascular Agents
Central Nervous System Agents
Chelating Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Fibrin Modulating Agents
Fibrinolytic Agents
Hematologic Agents
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 23, 2014