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

Vertigo, Peripheral Clinical Trial

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"

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02112578
• Other study ID #: APS 002/2013
• Secondary ID: BRA15APS002-2015
• Status: Completed
• Phase: Phase 3
• Start date: November 1, 2016
• Est. completion date: December 1, 2017

Study information

• Verified date: February 2023
• Source: Apsen Farmaceutica S.A.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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;

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 292
• Est. completion date: December 1, 2017
• Est. primary completion date: April 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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).

Related Conditions & MeSH terms

• Dizziness
• Vertigo
• Vertigo, Peripheral

Intervention

Drug:
• Meclizine
25 mg, 3 times per day up to 30 days
• Dimenhydrinate
50 mg, 3 times per day up to 30 days

Locations

Country	Name	City	State
Brazil	Alergoalpha	Barueri	São Paulo
Brazil	Clinilive	Maringá	Paraná
Brazil	Pesquisare Saude S/S Ltda	Santo André	São Paulo
Brazil	ISPEM	São José dos Campos	São Paulo
Brazil	CCBR SP	São Paulo
Brazil	Irmandade da Santa Casa de Misericórdia de São Paulo	São Paulo	SP
Brazil	Clinica de Alergia MarttiAntila	Sorocaba	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Apsen Farmaceutica S.A.

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Stanford and Epworth Sleepiness Scale	Evaluation of somnolence (baseline measurement)	up to 30 days
Other	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
Other	Duration of treatment (days from V0)	Evaluation of the duration of tratement from each group	up to 30 days
Other	Adherence rate to treatment	Evaluation of adherence rate from each group throughout the study	up to 30 days
Other	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
Other	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
Other	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
Other	Clinical and Physical findings	Evaluation of any changes in clinical / physical assessment findings since baseline	After the signature of SICF
Primary	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	Quality of Life Questionnaire DHI - Dizziness Handicap Inventory, validated for the Brazilian population	Evaluation of life quality	up to 30 days