Vertigo, Peripheral | Non Inferiority of Meclin® (Meclizine Chlorhydrate) Versus Dramin® (Dimenhydrinate) in Control of Acute Vertigo Symptoms From Peripheral Origin
Vertigo, Peripheral research study
What is the primary objective of this study?
- 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;
Who is eligible to participate?
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).
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:Meclizine25 mg, 3 times per day up to 30 days
Drug:Dimenhydrinate50 mg, 3 times per day up to 30 days
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
MeclizineMeclizine 25 mg, tablets
DimenhydrinateDimenhydrinate 50 mg, soft Capsgel
Start Date: November 2016
Completed Date: December 2017
Phase: Phase 3
Primary Outcome: Vertigo Score (VS)
Secondary Outcome: Quality of Life Questionnaire DHI - Dizziness Handicap Inventory, validated for the Brazilian population
Study sponsors, principal investigator, and references
Principal Investigator: Norton Sayeg, PhD
Lead Sponsor: Apsen Farmaceutica S.A.