Non Inferiority of Meclin® (Meclizine Chlorhydrate) Versus Dramin® (Dimenhydrinate) in Control of Acute Vertigo Symptoms From Peripheral Origin

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified December 2015 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: December 10, 2015
Last verified: December 2015
  Purpose
  • Evaluation of the non inferiority of Meclin (meclizine) versus Dramin (Dimenhydrinate) to treat the symptoms of acute vertigo from peripheral origin after up to 4 weeks of treatment;
  • Evaluation of impact on quality of life in vertigo;
  • Compare the intensity of daytime sleepiness in the two treatment groups;
  • Compare the efficacy of drugs in relieving each of the 10 symptoms that make up the VS;
  • Compare the duration of treatment in both treatment groups;
  • Compare Adehence;
  • Compare the level of satisfaction from each group from the investigators and the subjects;
  • Adverse events;

Condition Intervention Phase
Vertigo, Peripheral
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, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: " National, Phase III, Radomized, Double-Blind, Double -Dummy, Controlled, Parallel to Evaluate Non Inferiority of Meclin® (Meclizine Chlorhydrate) Versus Dramin® (Dimenhydrinate) Soft Gel Capsules in the Control of Acute Vertigo Symphtoms From Peripheral Origin"

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Vertigo Score (VS) [ Time Frame: up to 30 days ] [ Designated as safety issue: No ]
    Evaluation of non inferiority by measuring 10 symptoms of vertigo : distasia and instability when walking ; totter ; spinning sensation; tendency to fall; Continuous floating feeling ; floating sensation to change position ; floating sensation to bow down ; floating sensation when standing up ; floating sensation traveling on any means of transport; floating sensation with head movement ; floating sensation with eye movement. Each symptom is graduated in a semi -quantitative 5-point scale : 0 = no symptoms ; 1 = mild symptoms ; 2 = moderate symptoms ; 3 = strong symptoms ; 4 = very strong symptoms in all visits that the subject accomplishes.


Secondary Outcome Measures:
  • Quality of Life Questionnaire DHI - Dizziness Handicap Inventory, validated for the Brazilian population [ Time Frame: up to 30 days ] [ Designated as safety issue: No ]
    Evaluation of life quality


Other Outcome Measures:
  • Stanford and Epworth Sleepiness Scale [ Time Frame: up to 30 days ] [ Designated as safety issue: No ]
    Evaluation of somnolence (baseline measurement)

  • Variation of the intensity of each of the 10 symptoms [ Time Frame: up to 30 days ] [ Designated as safety issue: No ]
    Evaluation of the variation of the intensity of each of the 10 symptoms that make up VS, along the visits

  • Duration of treatment (days from V0) [ Time Frame: up to 30 days ] [ Designated as safety issue: No ]
    Evaluation of the duration of tratement from each group

  • Adherence rate to treatment [ Time Frame: up to 30 days ] [ Designated as safety issue: No ]
    Evaluation of adherence rate from each group throughout the study

  • Visual analogue scale (VAS) for subjects and for investigators [ Time Frame: up to 30 days ] [ Designated as safety issue: No ]
    For the subjective assessment of the participant and investigator's research on the treatment applied in 1,2,3 visits and final (VF);

  • Participants Percentage with any symptoms classified as moderate (score ≥2) [ Time Frame: Since last Visit ] [ Designated as safety issue: No ]

    Evaluation of participants percentage with any symptoms classified as moderate on the VS Scale on the follow-up visit, held 7 ± 2 days after the final inspection (VF).

    through the study.


  • Analysis of Adverse Events [ Time Frame: After the signature of SICF ] [ Designated as safety issue: Yes ]
    Evaluation of any Adverse Event ou Serious Adverse Event recorded after the signing of the Informed Consent ( IC) and until the end of the study

  • Clinical and Physical findings [ Time Frame: After the signature of SICF ] [ Designated as safety issue: Yes ]
    Evaluation of any changes in clinical / physical assessment findings since baseline


Estimated Enrollment: 292
Study Start Date: March 2016
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2016 (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 up to 30 days
Other Name: Meclin
Active Comparator: Dimenhydrinate
Dimenhydrinate 50 mg, soft Capsgel
Drug: Dimenhydrinate
50 mg, 3 times per day up to 30 days
Other Name: Dramin

Detailed Description:

It is a prospective interventional study arms parallel , active -controlled , non-inferiority . Participants selected for the study should be of both sexes , aged over 18 years and less than 65, which meet all the inclusion criteria and did not fit any exclusion criteria , and agree to all the purposes of the study. Participants are divided into two according to the randomization treatment groups 1:1.

The study should take no longer than 30 days to be completed with the amount of 6 visits (7±2 days): V0 radomization; V1, V2, V3 andV4(FV) are Evaluation visits and One Follow up visit 7±2 days after the Final Visit.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Men and women aged over 18 years and less than 65;
  • Presence of vertigo episodes of vestibular origin (peripheral ) of moderate intensity , strong or very strong according to the VS range ;
  • Participants who are able to swallow tablets / capsules;
  • Participants able to understand the guidance and care of this study and cooperative ;
  • Participants with the requisite understanding, in accordance with Good Clinical Practice Research Document of the Americas.

Exclusion Criteria:

  • Use of meclizine or dimenidrynate in the actual event or in the past 15 days;
  • Use of alcohol in the past 48 hours;
  • Presence of vomiting which prevent the ingestion of tablets;
  • Pregnancy or breastfeeding;
  • 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, porphyria, know history of hipersensibility to the Actives or Excipients from the study medications;
  • Malignancies History , even if no evidence of active disease for less than five years . Those without active disease for more than five years may be included;
  • Uncontrolled systemic arterial hypertension ( > 140/90 mmHg );
  • Decompensated diabetes mellitus (blood glucose at any time > 200 mg / dL );
  • Participants with asthma or chronic obstructive pulmonary disease;
  • Participants making use of antihistamines with anti-vertigo effect ( betahistine, meclizine , diphenidol ) , drugs with antagonist calcium channel action ( cinnarizine , flunarizine ) , anticholinergic drugs ( metoclopramide , dimenhydrinate , meclizine , diphenidol , scopolamine, ondansetron, granisetron ) , antiseizure drugs ( diazepam , clonazepam , carbamazepine ) and other central nervous system depressants;
  • Participants with central origin vertigo or non-vestibular;
  • Participants with positional benign positional paroxysmal vertigo (bppv).
  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: Thainá Moraes, BSc 55 11 5645-5150 thaina.moraes@apsen.com.br

Locations
Brazil
Clinilive Not yet recruiting
Maringá, Paraná, Brazil
Contact: Antonio Carlos da Silva    55 44 30293004      
Principal Investigator: Antonio Carolos da Silva         
Irmandade da Santa Casa de Misericórdia de São Paulo Not yet recruiting
São Paulo, SP, Brazil
Contact: Monica Alcantra    55 11 21767235      
Principal Investigator: José Eduardo Lutaif Dolci         
Alergoalpha Not yet recruiting
Barueri, São Paulo, Brazil, 06454010
Contact: Thainara Bisognini    55 11 46882251      
Principal Investigator: Karina Tavares         
Pesquisare Saude S/S Ltda Not yet recruiting
Santo André, São Paulo, Brazil, 09080110
Contact: Amanda Faulhaber    55 11 44273339      
Principal Investigator: Amanda Faulhaber         
Clinica de Alergia MarttiAntila Not yet recruiting
Sorocaba, São Paulo, Brazil, 18040425
Contact: Simone Fernandes    55 15 35194909      
Principal Investigator: Martti Anton Antila         
ISPEM Not yet recruiting
São José dos Campos, São Paulo, Brazil, 12243280
Contact: Renata Bolsolani    55 12 39131789      
Principal Investigator: Marcio Antonio Pereira         
CCBR SP Not yet recruiting
São Paulo, Brazil, 04063001
Contact: Norton Sayeg, PhD    5511 43064691      
Principal Investigator: Norton Sayeg, PhD         
Sponsors and Collaborators
Apsen Farmaceutica S.A.
Investigators
Principal Investigator: Norton Sayeg, PhD CCBR SP
  More Information

Responsible Party: Apsen Farmaceutica S.A.
ClinicalTrials.gov Identifier: NCT02112578     History of Changes
Other Study ID Numbers: APS 002/2013  BRA15APS002-2015  U1111-1149-6768 
Study First Received: April 10, 2014
Last Updated: December 10, 2015
Health Authority: Brazil: National Health Surveillance Agency
Individual Participant Data  
Plan to Share IPD: No

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

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
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 July 25, 2016