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

• Register: REBEC
• Last refreshed on: 29 May 2023
• Main ID: RBR-3pyzt5
• Date of registration: 10/03/2015
• Prospective Registration: Yes
• Primary sponsor: Universidade Federal de São Paulo - UNIFESP/EPM
• Public title: Efficacy and tolerability of Meclin® (meclizine hydrochloride) in Acute vertigo (a type of dizziness) and other types of dizzy spells identified by Otorhinolaryngologist
• Scientific title: Eficacy and tolerability of Meclin®(Meclizine Chlorhydrate) in acute vertigo
• Date of first enrolment: 23/03/2015
• Recruitment status: Not yet recruiting
• URL: http://ensaiosclinicos.gov.br/rg/RBR-3pyzt5
• Study type: Intervention
• Study design: A clinical trial of efficacy and tolerability, randomized, controlled, parallel, double-blind, two-arm, phase 3
• Phase: 3

Countries of recruitment

Brazil

Contacts

• Name: Carina Sotoriva Ribeiro Lovato
• Affiliation: Apsen Farmacêutica S/A

• Name: Carina Sotoriva Ribeiro Lovato
• Affiliation: Apsen Farmacêutica S/A

Key inclusion & exclusion 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: 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;

Age minimum: 18Y
Age maximum: 75Y
Gender: -

Health Condition(s) or Problem(s) studied

C09.218.568.217.500

C09.218.568.900.883

H81.1

H81.4

C10.597.751.237

Vertigo; dizziness.

Intervention(s)

Drug

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 - 100 people will receive the drug dimenhydrinate (Dramin®) 50mg and should be taken the same follows: 1 tablete every 8 hours for a maximum of 16 days and at least 14 days.

E05.337.425

N02.421.668.438

Primary Outcome(s)

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 Outcome(s)

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

Source(s) of Monetary Support

Apsen Farmacêutica S/A

Secondary Sponsor(s)

Apsen Farmacêutica S/A