* Evaluation of the non inferiority of Meclin (meclizine) versus Dramin (Dimenhydrinate) to treat the symptoms of acute vertigo from peripheral origin after up to 4 weeks of treatment; * Evaluation of impact on quality of life in vertigo; * Compare the intensity of daytime sleepiness in the two treatment groups; * Compare the efficacy of drugs in relieving each of the 10 symptoms that make up the VS; * Compare the duration of treatment in both treatment groups; * Compare Adehence; * Compare the level of satisfaction from each group from the investigators and the subjects; * Adverse events;
It is a prospective interventional study arms parallel , active -controlled , non-inferiority . Participants selected for the study should be of both sexes , aged over 18 years and less than 65, which meet all the inclusion criteria and did not fit any exclusion criteria , and agree to all the purposes of the study. Participants are divided into two according to the randomization treatment groups 1:1. The study should take no longer than 30 days to be completed with the amount of 6 visits (7±2 days): V0 radomization; V1, V2, V3 andV4(FV) are Evaluation visits and One Follow up visit 7±2 days after the Final Visit.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
292
25 mg, 3 times per day up to 30 days
50 mg, 3 times per day up to 30 days
Clinilive
Maringá, Paraná, Brazil
Alergoalpha
Barueri, São Paulo, Brazil
Pesquisare Saude S/S Ltda
Santo André, São Paulo, Brazil
ISPEM
São José dos Campos, São Paulo, Brazil
Irmandade da Santa Casa de Misericórdia de São Paulo
São Paulo, São Paulo, Brazil
Clinica de Alergia MarttiAntila
Sorocaba, São Paulo, Brazil
CCBR SP
São Paulo, Brazil
Vertigo Score (VS)
Evaluation of non inferiority by measuring 10 symptoms of vertigo : distasia and instability when walking ; totter ; spinning sensation; tendency to fall; Continuous floating feeling ; floating sensation to change position ; floating sensation to bow down ; floating sensation when standing up ; floating sensation traveling on any means of transport; floating sensation with head movement ; floating sensation with eye movement. Each symptom is graduated in a semi -quantitative 5-point scale : 0 = no symptoms ; 1 = mild symptoms ; 2 = moderate symptoms ; 3 = strong symptoms ; 4 = very strong symptoms in all visits that the subject accomplishes.
Time frame: up to 30 days
Quality of Life Questionnaire DHI - Dizziness Handicap Inventory, validated for the Brazilian population
Evaluation of life quality
Time frame: up to 30 days
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