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

Phase 3

Completed

• Conditions: Vertigo, Peripheral
• Interventions: Drug: Meclizine; Drug: Dimenhydrinate

• Registration Number: NCT02112578
• Lead Sponsor: Apsen Farmaceutica S.A.

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.

Study Timeline

• Study First Submitted: 2014-04-10
• Study First Submitted QC: 2014-04-10
• Study First Posted: 2014-04-14
• Study Start: 2016-11-01
• Primary Completion: 2017-04-01
• Study Completion: 2017-12-01
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-07
• Last Update Posted: 2023-02-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 292

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Meclizine	Meclizine	Meclizine 25 mg, tablets
Dimenhydrinate	Dimenhydrinate	Dimenhydrinate 50 mg, soft Capsgel

Primary Outcome Measures

Name	Time	Method
Vertigo Score (VS)	up to 30 days	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.

Secondary Outcome Measures

Name	Time	Method
Quality of Life Questionnaire DHI - Dizziness Handicap Inventory, validated for the Brazilian population	up to 30 days	Evaluation of life quality

Trial Locations

Locations (7)

Clinica de Alergia MarttiAntila; 🇧🇷 Sorocaba, São Paulo, Brazil

ISPEM; 🇧🇷 São José dos Campos, São Paulo, Brazil

Clinilive; 🇧🇷 Maringá, Paraná, Brazil

Irmandade da Santa Casa de Misericórdia de São Paulo; 🇧🇷 São Paulo, SP, Brazil

Alergoalpha; 🇧🇷 Barueri, São Paulo, Brazil

Pesquisare Saude S/S Ltda; 🇧🇷 Santo André, São Paulo, Brazil

CCBR SP; 🇧🇷 São Paulo, Brazil