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COMPLETED

NCT02112578

PHASE3

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

Sponsor: Apsen Farmaceutica S.A.

View on ClinicalTrials.gov

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;

Official title: " 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"

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

292

Start Date

2016-11-01

Completion Date

2017-12-01

Last Updated

2026-09-08

Healthy Volunteers

Conditions

Vertigo, Peripheral

Interventions

DRUG

Meclizine

25 mg, 3 times per day up to 30 days

DRUG

Dimenhydrinate

50 mg, 3 times per day up to 30 days

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).

Locations (7)

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

CCBR SP

São Paulo, São Paulo, Brazil

Irmandade da Santa Casa de Misericórdia de São Paulo