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

Study Overview
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Brief Summary
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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;

Detailed Description
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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.

Official Title
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 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

Conditions
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Vertigo, Peripheral

Intervention / Treatment
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* Drug: Meclizine
* Drug: Dimenhydrinate


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Meclizine<br>Meclizine 25 mg, tablets | Drug: Meclizine<br>* 25 mg, 3 times per day up to 30 days<br>* Other names: Meclin;|
| Active Comparator: Dimenhydrinate<br>Dimenhydrinate 50 mg, soft Capsgel | Drug: Dimenhydrinate<br>* 50 mg, 3 times per day up to 30 days<br>* Other names: Dramin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | up to 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Life Questionnaire DHI - Dizziness Handicap Inventory, validated for the Brazilian population | Evaluation of life quality | up to 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Vertigo, Meclizine, dimenhydrinate, Peripheral Origin