Clinical trial NCT01012349: 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.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Treatment of Episodic Tension Headache
Lead sponsor: Azidus Brasil
Sponsor class: INDUSTRY
First posted: 2009-11-13
Enrollment: 152
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: The primary efficacy endpoint is the rate of sustained response (percentage of subjects who have no pain) two hours after the drug administration.
timeFrame: 0, 30, 60, 90 and 120 minutes
Secondary outcomes:
measure: • 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
timeFrame: 30, 60, 90 and 120 minutes after administration
Other outcomes:
Locations:
city: Valinhos
country: Brazil
facility: Lal Clinica Pesquisa E Desenvolvimento Ltda
state: SP
Study officials:
References: