Eficacy and Tolerability of MECLIN� (Meclizine Chlorhydrate) in Acute Vertigo and Manifestations Neurovegetative

Condition(s) targeted: Vertigo; Vestibular Disease

Intervention: Meclizine (Drug); Dimenhydrinate (Drug)

Phase: Phase 3

Status: Not yet recruiting

Sponsored by: Apsen Farmaceutica S.A.

Official(s) and/or principal investigator(s):
Fernando Ganança, PhD, Principal Investigator, Affiliation: Federal University of São Paulo

Overall contact:
Cristiane Lima, Phone: 55 11 5644-8200, Ext: 8269, Email: cristiane.lima@apsen.com.br

- Evaluation of the efficacy and tolerability of Meclin (meclizine) versus Dramin

(Dimenhydrinate) to treat the symptoms of vertigo;

- Evaluation of impact on quality of life in vertigo;

- Evaluation of drowsiness caused by antihistamines used in the study;

- Adverse event;

Official title: Eficacy and Tolerability of MECLIN® (Meclizine Chlorhydrate) in Acute Vertigo and Manifestations Neurovegetative

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: Media Vertigo score (MVS)

Secondary outcome: Dizziness Handicap Inventory (Brazilian version)

Detailed description:

- The study duration will be 15 days (visit 1, visit 2, and visit 3);

- Symptoms of vertigo will be assessed at every visit, through a daily participant in the

study report the intensity of their symptoms and outcome.

- Goal is the acquisition of data as proportion of participants with MVS= 0. 5 considered

treatment responders, and proportion of patients with symptoms higher percentage reduction of 50%

Minimum age: 18 Years. Maximum age: 75 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Men and Woman aged above 18 years;

- Presence of dizziness / vertigo of vestibular origin symptons , and / or

neurovegetative manifestations due to peripheral vestibular disorders;

- Participant with dizziness / vertigo of vestibular origin symptoms, show moderate

intensity on in 5-points Likert scale of: absent, mild , moderate , severe and very severe;

- Woman with negative Beta hcg;

- Participants 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;

Cristiane Lima, Phone: 55 11 5644-8200, Ext: 8269, Email: cristiane.lima@apsen.com.br

Otorhinolaryngology Department of Federal University of São Paulo, São Paulo 04039-032, Brazil; Not yet recruiting
Fernando Ganança, PhD, Phone: 55115539-5378
Fernando Ganança, PhD, Principal Investigator

IPO - Parana Otorhinolaryngology Institute, Curitiba, Parana 80610-010, Brazil; Not yet recruiting
Alexandre Gasperin, MD, Phone: 55 41 3094-5751
Alexandre Gasperin, MD, Principal Investigator

Starting date: August 2014
Last updated: April 10, 2014