Trial record 7 of 31 for:    Open Studies | "Vestibular Diseases"

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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified February 2014 by Apsen Farmaceutica S.A.
Sponsor:
Information provided by (Responsible Party):
Apsen Farmaceutica S.A.
ClinicalTrials.gov Identifier:
NCT02112578
First received: April 10, 2014
Last updated: NA
Last verified: February 2014
History: No changes posted
  Purpose
  • 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;

Condition Intervention Phase
Vertigo
Vestibular Disease
Drug: Meclizine
Drug: Dimenhydrinate
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Eficacy and Tolerability of MECLIN® (Meclizine Chlorhydrate) in Acute Vertigo and Manifestations Neurovegetative

Resource links provided by NLM:


Further study details as provided by Apsen Farmaceutica S.A.:

Primary Outcome Measures:
  • Media Vertigo score (MVS) [ Time Frame: 15 days ] [ Designated as safety issue: No ]
    Evaluation of efficacy by varying the Media Vertigo score (MVS) which is the average of the intensities of vertigo symptoms described at Visit 1, assigning the scores to 0-4 categories None, Mild, Moderate, Strong, Very Strong, respectively. The primary hypothesis is the non-inferiority of Meclizine chlorhydrate regarding Dimenidrinato in reducing the MVS V1 to V2.


Secondary Outcome Measures:
  • Dizziness Handicap Inventory (Brazilian version) [ Time Frame: 15 days ] [ Designated as safety issue: No ]
    Evaluation of impact of dizziness on quality of life DHI


Other Outcome Measures:
  • Stanford Sleepiness and Epworth [ Time Frame: 15 days ] [ Designated as safety issue: No ]
    Evaluation of somnolence (baseline measurement)


Estimated Enrollment: 200
Study Start Date: August 2014
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Meclizine
Meclizine 25 mg, tablets
Drug: Meclizine
25 mg, 3 times per day for 15 days
Other Name: Meclin
Active Comparator: Dimenhydrinate
Dimenhydrinate 50 mg, soft Capsgel
Drug: Dimenhydrinate
50 mg, 3 times per day for 15 days
Other Name: Dramin

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%
  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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;
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02112578

Contacts
Contact: Cristiane Lima 55 11 5644-8200 ext 8269 cristiane.lima@apsen.com.br

Locations
Brazil
IPO - Parana Otorhinolaryngology Institute Not yet recruiting
Curitiba, Parana, Brazil, 80610-010
Contact: Alexandre Gasperin, MD    55 41 3094-5751      
Principal Investigator: Alexandre Gasperin, MD         
Otorhinolaryngology Department of Federal University of São Paulo Not yet recruiting
São Paulo, Brazil, 04039-032
Contact: Fernando Ganança, PhD    55115539-5378      
Principal Investigator: Fernando Ganança, PhD         
Sponsors and Collaborators
Apsen Farmaceutica S.A.
Investigators
Principal Investigator: Fernando Ganança, PhD Federal University of São Paulo
  More Information

No publications provided

Responsible Party: Apsen Farmaceutica S.A.
ClinicalTrials.gov Identifier: NCT02112578     History of Changes
Other Study ID Numbers: APS 002/2013, BRA13APS002-2014, U1111-1149-6768
Study First Received: April 10, 2014
Last Updated: April 10, 2014
Health Authority: Brazil: National Health Surveillance Agency

Keywords provided by Apsen Farmaceutica S.A.:
Vertigo, Meclizine

Additional relevant MeSH terms:
Vestibular Diseases
Vertigo
Dizziness
Labyrinth Diseases
Ear Diseases
Otorhinolaryngologic Diseases
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Sensation Disorders
Meclizine
Dimenhydrinate
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Gastrointestinal Agents
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anti-Allergic Agents

ClinicalTrials.gov processed this record on August 28, 2014