Treatment of Episodic Tension Headache
Conditions
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.
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.
Interventions
DRUGAssociation: acetylsalicylic acid (500mg), sodium bicarbonate (1625) and citric acid (965)
1 tablet in an episody of headache
DRUGAspirin - Bayer
1 tablet in an episody of headache (Aspirin 500mg)
Sponsors
Azidus Brasil
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| 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. | 0, 30, 60, 90 and 120 minutes |
Secondary
| 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 | 30, 60, 90 and 120 minutes after administration |
Countries
Brazil
Contacts
Primary Contactalexandre Frederico, physician
Outcome results
None listed