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

NCT ID: NCT02112578

Last Updated: 2023-02-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 292 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-11-01
• Study Completion Date: 2017-12-01

Brief 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;

Detailed 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.

Conditions

Vertigo, Peripheral

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Meclizine

Meclizine 25 mg, tablets

Group Type: EXPERIMENTAL

Meclizine

Intervention Type: DRUG

25 mg, 3 times per day up to 30 days

Dimenhydrinate

Dimenhydrinate 50 mg, soft Capsgel

Group Type: ACTIVE_COMPARATOR

Dimenhydrinate

Intervention Type: DRUG

50 mg, 3 times per day up to 30 days

Interventions

Meclizine

25 mg, 3 times per day up to 30 days

Intervention Type: DRUG

Dimenhydrinate

50 mg, 3 times per day up to 30 days

Intervention Type: DRUG

Other Intervention Names

Meclin; Dramin

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Apsen Farmaceutica S.A.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Norton Sayeg, PhD

Role: PRINCIPAL_INVESTIGATOR

CCBR SP

Locations

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

Irmandade da Santa Casa de Misericórdia de São Paulo

São Paulo, São Paulo, Brazil

Clinica de Alergia MarttiAntila

Sorocaba, São Paulo, Brazil

CCBR SP

São Paulo, , Brazil

Countries

Brazil

Other Identifiers

BRA15APS002-2015

Identifier Type: OTHER

Identifier Source: secondary_id

U1111-1149-6768

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

APS 002/2013

Identifier Type: -

Identifier Source: org_study_id