Clinical trial NCT02112578: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Vertigo, Peripheral
Keywords: Vertigo, Meclizine, dimenhydrinate, Peripheral Origin
Lead sponsor: Apsen Farmaceutica S.A.
Sponsor class: INDUSTRY
First posted: 2014-04-14
Enrollment: 292
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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).

Primary outcomes:
measure: Vertigo Score (VS)
timeFrame: up to 30 days
Secondary outcomes:
measure: Quality of Life Questionnaire DHI - Dizziness Handicap Inventory, validated for the Brazilian population
timeFrame: up to 30 days
Other outcomes:
measure: Stanford and Epworth Sleepiness Scale
timeFrame: up to 30 days
measure: Variation of the intensity of each of the 10 symptoms
timeFrame: up to 30 days
measure: Duration of treatment (days from V0)
timeFrame: up to 30 days
measure: Adherence rate to treatment
timeFrame: up to 30 days
measure: Visual analogue scale (VAS) for subjects and for investigators
timeFrame: up to 30 days
measure: Participants Percentage with any symptoms classified as moderate (score ≥2)
timeFrame: Since last Visit
measure: Analysis of Adverse Events
timeFrame: After the signature of SICF
measure: Clinical and Physical findings
timeFrame: After the signature of SICF
Locations:
city: Maringá
country: Brazil
facility: Clinilive
state: Paraná
city: São Paulo
country: Brazil
facility: Irmandade da Santa Casa de Misericórdia de São Paulo
state: SP
city: Barueri
country: Brazil
facility: Alergoalpha
state: São Paulo
city: Santo André
country: Brazil
facility: Pesquisare Saude S/S Ltda
state: São Paulo
city: Sorocaba
country: Brazil
facility: Clinica de Alergia MarttiAntila
state: São Paulo
city: São José dos Campos
country: Brazil
facility: ISPEM
state: São Paulo
city: São Paulo
country: Brazil
facility: CCBR SP
Study officials:
affiliation: CCBR SP
name: Norton Sayeg, PhD
role: PRINCIPAL_INVESTIGATOR
References: