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

Primary Purpose

Vertigo, Peripheral

Status
Completed
Phase
Phase 3
Locations
Brazil
Study Type
Interventional
Intervention
Meclizine
Dimenhydrinate
Sponsored by
Apsen Farmaceutica S.A.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Vertigo, Peripheral focused on measuring Vertigo, Meclizine, dimenhydrinate, Peripheral Origin

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Clinilive
  • Irmandade da Santa Casa de Misericórdia de São Paulo
  • Alergoalpha
  • Pesquisare Saude S/S Ltda
  • Clinica de Alergia MarttiAntila
  • ISPEM
  • CCBR SP

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Meclizine

Dimenhydrinate

Arm Description

Meclizine 25 mg, tablets

Dimenhydrinate 50 mg, soft Capsgel

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Quality of Life Questionnaire DHI - Dizziness Handicap Inventory, validated for the Brazilian population
Evaluation of life quality

Full Information

First Posted
April 10, 2014
Last Updated
February 7, 2023
Sponsor
Apsen Farmaceutica S.A.
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1. Study Identification

Unique Protocol Identification Number
NCT02112578
Brief Title
Non Inferiority of Meclin® (Meclizine Chlorhydrate) Versus Dramin® (Dimenhydrinate) in Control of Acute Vertigo Symptoms From Peripheral Origin
Official Title
" 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"
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
November 1, 2016 (Actual)
Primary Completion Date
April 1, 2017 (Actual)
Study Completion Date
December 1, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Apsen Farmaceutica S.A.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vertigo, Peripheral
Keywords
Vertigo, Meclizine, dimenhydrinate, Peripheral Origin

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
292 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Meclizine
Arm Type
Experimental
Arm Description
Meclizine 25 mg, tablets
Arm Title
Dimenhydrinate
Arm Type
Active Comparator
Arm Description
Dimenhydrinate 50 mg, soft Capsgel
Intervention Type
Drug
Intervention Name(s)
Meclizine
Other Intervention Name(s)
Meclin
Intervention Description
25 mg, 3 times per day up to 30 days
Intervention Type
Drug
Intervention Name(s)
Dimenhydrinate
Other Intervention Name(s)
Dramin
Intervention Description
50 mg, 3 times per day up to 30 days
Primary Outcome Measure Information:
Title
Vertigo Score (VS)
Description
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.
Time Frame
up to 30 days
Secondary Outcome Measure Information:
Title
Quality of Life Questionnaire DHI - Dizziness Handicap Inventory, validated for the Brazilian population
Description
Evaluation of life quality
Time Frame
up to 30 days
Other Pre-specified Outcome Measures:
Title
Stanford and Epworth Sleepiness Scale
Description
Evaluation of somnolence (baseline measurement)
Time Frame
up to 30 days
Title
Variation of the intensity of each of the 10 symptoms
Description
Evaluation of the variation of the intensity of each of the 10 symptoms that make up VS, along the visits
Time Frame
up to 30 days
Title
Duration of treatment (days from V0)
Description
Evaluation of the duration of tratement from each group
Time Frame
up to 30 days
Title
Adherence rate to treatment
Description
Evaluation of adherence rate from each group throughout the study
Time Frame
up to 30 days
Title
Visual analogue scale (VAS) for subjects and for investigators
Description
For the subjective assessment of the participant and investigator's research on the treatment applied in 1,2,3 visits and final (VF);
Time Frame
up to 30 days
Title
Participants Percentage with any symptoms classified as moderate (score ≥2)
Description
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.
Time Frame
Since last Visit
Title
Analysis of Adverse Events
Description
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
Time Frame
After the signature of SICF
Title
Clinical and Physical findings
Description
Evaluation of any changes in clinical / physical assessment findings since baseline
Time Frame
After the signature of SICF

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Norton Sayeg, PhD
Organizational Affiliation
CCBR SP
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clinilive
City
Maringá
State/Province
Paraná
Country
Brazil
Facility Name
Irmandade da Santa Casa de Misericórdia de São Paulo
City
São Paulo
State/Province
SP
Country
Brazil
Facility Name
Alergoalpha
City
Barueri
State/Province
São Paulo
ZIP/Postal Code
06454010
Country
Brazil
Facility Name
Pesquisare Saude S/S Ltda
City
Santo André
State/Province
São Paulo
ZIP/Postal Code
09080110
Country
Brazil
Facility Name
Clinica de Alergia MarttiAntila
City
Sorocaba
State/Province
São Paulo
ZIP/Postal Code
18040425
Country
Brazil
Facility Name
ISPEM
City
São José dos Campos
State/Province
São Paulo
ZIP/Postal Code
12243280
Country
Brazil
Facility Name
CCBR SP
City
São Paulo
ZIP/Postal Code
04063001
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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