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.

Sponsor

Azidus Brasil (Industry)

Overall Status

Unknown status

CT.gov ID

NCT01012349

Collaborator

(none)

152

Enrollment

Location

Arms

5.9

Duration (Months)

25.6

Patients Per Site Per Month

Study Details

Study Description

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

152 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Study Start Date :

Feb 1, 2011

Anticipated Primary Completion Date :

May 1, 2011

Anticipated Study Completion Date :

Aug 1, 2011

Arms and Interventions

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)

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)

Outcome Measures

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. [0, 30, 60, 90 and 120 minutes]

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 [30, 60, 90 and 120 minutes after administration]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Lal Clinica Pesquisa E Desenvolvimento Ltda	Valinhos	SP	Brazil	13270000

Sponsors and Collaborators

Azidus Brasil

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

, ,

ClinicalTrials.gov Identifier:

NCT01012349

Other Study ID Numbers:

AASGEO0809
Version 2

First Posted:

Nov 13, 2009

Last Update Posted:

Jan 28, 2011

Last Verified:

Oct 1, 2010

Additional relevant MeSH terms:

Tension-Type Headache

Study Results

No Results Posted as of Jan 28, 2011