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.

January 27, 2011 updated by: Azidus Brasil
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

152

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Brazil
    • SP
      • Valinhos, SP, Brazil, 13270000
        • LAL Clínica Pesquisa e Desenvolvimento Ltda
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
0, 30, 60, 90 and 120 minutes

Secondary Outcome Measures

Outcome Measure
Time Frame
• 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
30, 60, 90 and 120 minutes after administration

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Azidus Brasil

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2011

Primary Completion (Anticipated)

May 1, 2011

Study Completion (Anticipated)

August 1, 2011

Study Registration Dates

First Submitted

November 12, 2009

First Submitted That Met QC Criteria

November 12, 2009

First Posted (Estimate)

November 13, 2009

Study Record Updates

Last Update Posted (Estimate)

January 28, 2011

Last Update Submitted That Met QC Criteria

January 27, 2011

Last Verified

October 1, 2010

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AASGEO0809
  • Version 2

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Treatment of Episodic Tension Headache

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

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Estonia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe