Treatment of Episodic Tension Headache Clinical Trial
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.
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment