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

• Status: Unknown status
• Trial end date: 2017-12-01
• Target enrollment: 0
• Participant gender: All

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;

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Apsen Farmaceutica S.A.
• Treatments: Dimenhydrinate; Meclizine

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).