Non Inferiority of Meclin® (Meclizine Chlorhydrate) Versus Dramin® (Dimenhydrinate) in Control of Acute Vertigo Symptoms From Peripheral Origin

" National, Phase III, Radomized, Double-Blind, Double -Dummy, Controlled, Parallel to Evaluate Non Inferiority of Meclin® (Meclizine Chlorhydrate) Versus Dramin® (Dimenhydrinate) Soft Gel Capsules in the Control of Acute Vertigo Symphtoms From Peripheral Origin"

• 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.

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).