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.

Treatment of Episodic Tension Headache Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01012349
• Other study ID #: AASGEO0809
• Secondary ID: Version 2
• Status: Not yet recruiting
• Phase: Phase 2/Phase 3
• First received: November 12, 2009
• Last updated: January 27, 2011
• Start date: February 2011
• Est. completion date: August 2011

Study information

• Verified date: October 2010
• Source: L.A.L Clinica Pesquisa e Desenvolvimento Ltda.
• Contact: alexandre Frederico, physician
• Phone: 55 19 3829-3822
• Email: dr.alexandre[@]alclinica.com.br
• Is FDA regulated: No
• Health authority: Brazil: National Health Surveillance Agency
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 152
• Est. completion date: August 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Headache
• Tension-Type Headache
• Treatment of Episodic Tension Headache

Intervention

Drug:
• Association: acetylsalicylic acid (500mg), sodium bicarbonate (1625) and citric acid (965)
1 tablet in an episody of headache
• Aspirin - Bayer
1 tablet in an episody of headache (Aspirin 500mg)

Locations

Country	Name	City	State
Brazil	Lal Clinica Pesquisa E Desenvolvimento Ltda	Valinhos	SP

Sponsors (1)

Lead Sponsor	Collaborator
L.A.L Clinica Pesquisa e Desenvolvimento Ltda.

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary efficacy endpoint is the rate of sustained response (percentage of subjects who have no pain) two hours after the drug administration.		0, 30, 60, 90 and 120 minutes	No
Secondary	• 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		30, 60, 90 and 120 minutes after administration	Yes