non inferiority of meclin® (meclizine chlorhydrate) versus dramin® (dimenhydrinate) in control of acute vertigo symptoms from peripheral origin

Conditions: Vertigo, Peripheral

Summary: * 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.

Eligibility criteria:
inclusion criteria: * men and women aged over 18 years and less than 65; * presence of vertigo episodes of vestibular origin (peripheral ) of moderate intensity , strong or very strong according to the vs range ; * participants who are able to swallow tablets / capsules; * participants able to understand the guidance and care of this study and cooperative ; * participants with the requisite understanding, in accordance with good clinical practice research document of the americas. exclusion criteria: * use of meclizine or dimenidrynate in the actual event or in the past 15 days; * use of alcohol in the past 48 hours; * presence of vomiting which prevent the ingestion of tablets; * pregnancy or breastfeeding; * presence of clinical condition that determines contraindication to the active substances : convulsions , suspected intracranial compressive processes , closed-angle glaucoma , prostatic adenoma with urinary disorders , liver diseases , endocrine , renal, and / or uncontrolled cardiovascular , parkinson's disease, porphyria, know history of hipersensibility to the actives or excipients from the study medications; * malignancies history , even if no evidence of active disease for less than five years . those without active disease for more than five years may be included; * uncontrolled systemic arterial hypertension ( \> 140/90 mmhg ); * decompensated diabetes mellitus (blood glucose at any time \> 200 mg / dl ); * participants with asthma or chronic obstructive pulmonary disease; * participants making use of antihistamines with anti-vertigo effect ( betahistine, meclizine , diphenidol ) , drugs with antagonist calcium channel action ( cinnarizine , flunarizine ) , anticholinergic drugs ( metoclopramide , dimenhydrinate , meclizine , diphenidol , scopolamine, ondansetron, granisetron ) , antiseizure drugs ( diazepam , clonazepam , carbamazepine ) and other central nervous system depressants; * participants with central origin vertigo or non-vestibular; * participants with positional benign positional paroxysmal vertigo (bppv).

Keywords: vertigo, meclizine, dimenhydrinate, peripheral origin