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

Last updated: February 7, 2023
Sponsor: Apsen Farmaceutica S.A.
Overall Status: Completed

Phase

3

Condition

Low Blood Pressure (Hypotension)

Dizzy/fainting Spells

Treatment

N/A

Clinical Study ID

NCT02112578
APS 002/2013
BRA15APS002-2015
U1111-1149-6768
  • Ages 18-65
  • All Genders

Study 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;

Eligibility Criteria

Inclusion

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 ClinicalPractice Research Document of the Americas.

Exclusion

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 activesubstances : convulsions , suspected intracranial compressive processes , closed-angleglaucoma , prostatic adenoma with urinary disorders , liver diseases , endocrine ,renal, and / or uncontrolled cardiovascular , Parkinson's disease, porphyria, knowhistory 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).

Study Design

Total Participants: 292
Study Start date:
November 01, 2016
Estimated Completion Date:
December 01, 2017

Study Description

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.

Connect with a study center

  • IPO - Parana Otorhinolaryngology Institute

    Curitiba, Parana 80610-010
    Brazil

    Site Not Available

  • Clinilive

    Maringá, Paraná
    Brazil

    Site Not Available

  • Irmandade da Santa Casa de Misericórdia de São Paulo

    São Paulo, SP
    Brazil

    Site Not Available

  • Alergoalpha

    Barueri, São Paulo 06454010
    Brazil

    Site Not Available

  • Pesquisare Saude S/S Ltda

    Santo André, São Paulo 09080110
    Brazil

    Site Not Available

  • Clinica de Alergia MarttiAntila

    Sorocaba, São Paulo 18040425
    Brazil

    Site Not Available

  • ISPEM

    São José dos Campos, São Paulo 12243280
    Brazil

    Site Not Available

  • CCBR SP

    São Paulo, 04063001
    Brazil

    Site Not Available

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