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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.

NCT01012349 · Status: UNKNOWN · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 152

Last updated 2011-01-28

No results posted yet for this study

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.

Conditions

  • Treatment of Episodic Tension Headache

Interventions

DRUG

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

1 tablet in an episody of headache

DRUG

Aspirin - Bayer

1 tablet in an episody of headache (Aspirin 500mg)

Sponsors & Collaborators

  • Azidus Brasil

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-02-28
Primary Completion
2011-05-31
Completion
2011-08-31

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01012349 on ClinicalTrials.gov