Efficacy and tolerability of Meclin® (meclizine hydrochloride) in Acute vertigo (a type of dizziness) and other types of dizzy spells identified by Otorhinolaryngologist

Phase 3

• Conditions: H81.4; H81.1; Vertigo; C09.218.568.900.883; dizziness.; C10.597.751.237; C09.218.568.217.500

• Registration Number: RBR-3pyzt5
• Lead Sponsor: niversidade Federal de São Paulo - UNIFESP/EPM

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-03-10
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: Not specified
• Target Recruitment: Not specified

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

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;

Study & Design

• Study Type: Intervention
• Study Design: Not specified