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

" 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"

• 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;

Study Overview

• Status: Completed
• Conditions: Vertigo, Peripheral
• Intervention / Treatment: Drug: Meclizine; Drug: Dimenhydrinate

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 Type: Interventional
• Enrollment (Actual): 292
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Thainá Moraes, BSc; Phone Number: 55 11 5645-5150; Email: thaina.moraes@apsen.com.br

Study Locations

• Brazil
  • São Paulo, Brazil, 04063001
    • CCBR SP
  • Paraná
    • Maringá, Paraná, Brazil
      • Clinilive
  • SP
    • São Paulo, SP, Brazil
      • Irmandade Da Santa Casa De Misericordia De Sao Paulo
  • São Paulo
    • Barueri, São Paulo, Brazil, 06454010
      • Alergoalpha
    • Santo André, São Paulo, Brazil, 09080110
      • Pesquisare Saude S/S Ltda
    • Sorocaba, São Paulo, Brazil, 18040425
      • Clinica de Alergia MarttiAntila
    • São José dos Campos, São Paulo, Brazil, 12243280
      • ISPEM

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Meclizine; Meclizine 25 mg, tablets	Drug: Meclizine; 25 mg, 3 times per day up to 30 days; Other Names: Meclin
ACTIVE_COMPARATOR: Dimenhydrinate; Dimenhydrinate 50 mg, soft Capsgel	Drug: Dimenhydrinate; 50 mg, 3 times per day up to 30 days; Other Names: Dramin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of Life Questionnaire DHI - Dizziness Handicap Inventory, validated for the Brazilian population	Evaluation of life quality	up to 30 days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Stanford and Epworth Sleepiness Scale	Evaluation of somnolence (baseline measurement)	up to 30 days
Variation of the intensity of each of the 10 symptoms	Evaluation of the variation of the intensity of each of the 10 symptoms that make up VS, along the visits	up to 30 days
Duration of treatment (days from V0)	Evaluation of the duration of tratement from each group	up to 30 days
Adherence rate to treatment	Evaluation of adherence rate from each group throughout the study	up to 30 days
Visual analogue scale (VAS) for subjects and for investigators	For the subjective assessment of the participant and investigator's research on the treatment applied in 1,2,3 visits and final (VF);	up to 30 days
Participants Percentage with any symptoms classified as moderate (score ≥2)	Evaluation of participants percentage with any symptoms classified as moderate on the VS Scale on the follow-up visit, held 7 ± 2 days after the final inspection (VF). through the study.	Since last Visit
Analysis of Adverse Events	Evaluation of any Adverse Event ou Serious Adverse Event recorded after the signing of the Informed Consent ( IC) and until the end of the study	After the signature of SICF
Clinical and Physical findings	Evaluation of any changes in clinical / physical assessment findings since baseline	After the signature of SICF

Collaborators and Investigators

• Sponsor: Apsen Farmaceutica S.A.

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 1, 2016
• Primary Completion (ACTUAL): April 1, 2017
• Study Completion (ACTUAL): December 1, 2017

Study Registration Dates

• First Submitted: April 10, 2014
• First Submitted That Met QC Criteria: April 10, 2014
• First Posted (ESTIMATE): April 14, 2014

Study Record Updates

• Last Update Posted (ACTUAL): February 8, 2023
• Last Update Submitted That Met QC Criteria: February 7, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: Vertigo, Meclizine, dimenhydrinate, Peripheral Origin
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Otorhinolaryngologic Diseases; Labyrinth Diseases; Ear Diseases; Vestibular Diseases; Sensation Disorders; Vertigo; Dizziness; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Antiemetics; Gastrointestinal Agents; Anti-Allergic Agents; Histamine H1 Antagonists; Histamine Antagonists; Histamine Agents; Meclizine; Dimenhydrinate
• Other Study ID Numbers: APS 002/2013; BRA15APS002-2015 (OTHER: Apsen); U1111-1149-6768 (OTHER_GRANT: World Health Organization)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO