Vertigo
Conditions
Interventions
Gropup 1 - 100 people will receive the drug meclizine hydrocloride(Meclin®) 25mg and should be taken the same as follows: 1 tablet every 8 hours for a maximum of 16 days and at least 14 days.Group 2 -
Drug
Sponsors
Universidade Federal de São Paulo - UNIFESP/EPM
Apsen Farmacêutica S/A
Eligibility
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: Men and Woman aged above 18 years with presence of dizziness / vertigo of vestibular origin symptons , due to peripheral vestibular disorders, with dizziness / vertigo of vestibular origin symptoms, show moderate intensity on in 5-points Likert scale of: absent, mild , moderate , severe and very severe, if woman, negative Beta hcg and who present normal or controlled blood pressure;
Exclusion criteria
Exclusion criteria: Used meclizine or dimenidrynate in 15 days; Used alcohol in 48 hours; Pregnancy or breastfeeding; Presence of vomiting which prevent the ingestion of tablets; 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; Participants with bladder neck obstruction or symptomatic prostatic hyperplasia : anticholinergic effects of Meclizine may precipitate urinary retention; a known sensitivity to hydrochloride, meclizine or dimenhydrinate; Presence of malignant carcinomas or not remitted for more than 5 years;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Increasing the effectiveness of treatment, reducing the intensity of vertigo symptoms at visit 1, evaluated using the Mean Score of Vertigo (MVS) between 0-4 corresponding to the categories None, Mild, Moderate, Strong, Very Strong, respectively. The primary hypothesis is the non-inferiority of Meclizine hydrochloride with respect to the reduction of Dimenhydrinate MVS V1 to V2. | — |
Secondary
| Measure | Time frame |
|---|---|
| Improvement on quality of life assessed by the Brazilian version of the Dizziness Handicap Inventory (DHI) and reduced sleepiness assessed by the Stanford Sleepiness scales and Epworth | — |
Countries
Brazil
Contacts
Public ContactCarina Sotoriva Ribeiro Lovato
Apsen Farmacêutica S/A
Outcome results
None listed