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

NCT02112578 | Completed Phase 3

• 3 other identifiers: APS 002/2013BRA15APS002-2015U1111-1149-6768
• Study Type: interventional
• Target: 292
• Locations: 1 country
• Sites: 7

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;

Conditions

Vertigo, Peripheral

Keywords

Vertigo, Meclizine, dimenhydrinate, Peripheral Origin

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Quality of Life Questionnaire DHI - Dizziness Handicap Inventory, validated for the Brazilian population

  up to 30 days

Other Outcomes (8)

• Stanford and Epworth Sleepiness Scale

  up to 30 days

• Variation of the intensity of each of the 10 symptoms

  up to 30 days

• Duration of treatment (days from V0)

  up to 30 days

Study Arms (2)

Meclizine

EXPERIMENTAL

Meclizine 25 mg, tablets

Drug: Meclizine

Dimenhydrinate

ACTIVE COMPARATOR

Dimenhydrinate 50 mg, soft Capsgel

Drug: Dimenhydrinate

Interventions

Meclizine DRUG

25 mg, 3 times per day up to 30 days

Also known as: Meclin

Meclizine

Dimenhydrinate DRUG

50 mg, 3 times per day up to 30 days

Also known as: Dramin

Dimenhydrinate

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Apsen Farmaceutica S.A.: lead

Study Sites (7)

Clinilive

Maringá, Paraná, Brazil

Location

Alergoalpha

Barueri, São Paulo, 06454010, Brazil

Location

Pesquisare Saude S/S Ltda

Santo André, São Paulo, 09080110, Brazil

Location

ISPEM

São José dos Campos, São Paulo, 12243280, Brazil

Location

Irmandade da Santa Casa de Misericórdia de São Paulo

São Paulo, São Paulo, Brazil

Location

Clinica de Alergia MarttiAntila

Sorocaba, São Paulo, 18040425, Brazil

Location

CCBR SP

São Paulo, 04063001, Brazil

Location

MeSH Terms

Conditions

Vertigo

Interventions

Meclizine; Dimenhydrinate

Condition Hierarchy (Ancestors)

Vestibular Diseases; Labyrinth Diseases; Ear Diseases; Otorhinolaryngologic Diseases; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Benzhydryl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Diphenhydramine; Ethylamines; Amines; Theophylline; Xanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Drug Combinations; Pharmaceutical Preparations

Study Officials

• Norton Sayeg, PhD

  CCBR SP

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 10, 2014
• First Posted: April 14, 2014
• Study Start: November 1, 2016
• Primary Completion: April 1, 2017
• Study Completion: December 1, 2017
• Last Updated: February 8, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

BR (7)