Non Inferiority of Meclin® (Meclizine Chlorhydrate) Versus Dramin® (Dimenhydrinate) in Control of Acute Vertigo Symptoms From Peripheral Origin
Study Details
Study Description
Brief Summary
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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;
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Evaluation of impact on quality of life in vertigo;
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Compare the intensity of daytime sleepiness in the two treatment groups;
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Compare the efficacy of drugs in relieving each of the 10 symptoms that make up the VS;
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Compare the duration of treatment in both treatment groups;
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Compare Adehence;
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Compare the level of satisfaction from each group from the investigators and the subjects;
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Adverse events;
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 3 |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Meclizine Meclizine 25 mg, tablets |
Drug: Meclizine
25 mg, 3 times per day up to 30 days
Other Names:
|
| Active Comparator: Dimenhydrinate Dimenhydrinate 50 mg, soft Capsgel |
Drug: Dimenhydrinate
50 mg, 3 times per day up to 30 days
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Vertigo Score (VS) [up to 30 days]
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 [up to 30 days]
Evaluation of life quality
Other Outcome Measures
- Stanford and Epworth Sleepiness Scale [up to 30 days]
Evaluation of somnolence (baseline measurement)
- Variation of the intensity of each of the 10 symptoms [up to 30 days]
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) [up to 30 days]
Evaluation of the duration of tratement from each group
- Adherence rate to treatment [up to 30 days]
Evaluation of adherence rate from each group throughout the study
- Visual analogue scale (VAS) for subjects and for investigators [up to 30 days]
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) [Since last Visit]
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 [After the signature of SICF]
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 [After the signature of SICF]
Evaluation of any changes in clinical / physical assessment findings since baseline
Eligibility Criteria
Criteria
Inclusion Criteria:
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Men and women aged over 18 years and less than 65;
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Presence of vertigo episodes of vestibular origin (peripheral ) of moderate intensity , strong or very strong according to the VS range ;
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Participants who are able to swallow tablets / capsules;
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Participants able to understand the guidance and care of this study and cooperative ;
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Participants with the requisite understanding, in accordance with Good Clinical Practice Research Document of the Americas.
Exclusion Criteria:
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Use of meclizine or dimenidrynate in the actual event or in the past 15 days;
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Use of alcohol in the past 48 hours;
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Presence of vomiting which prevent the ingestion of tablets;
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Pregnancy or breastfeeding;
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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;
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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;
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Uncontrolled systemic arterial hypertension ( > 140/90 mmHg );
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Decompensated diabetes mellitus (blood glucose at any time > 200 mg / dL );
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Participants with asthma or chronic obstructive pulmonary disease;
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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;
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Participants with central origin vertigo or non-vestibular;
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Participants with positional benign positional paroxysmal vertigo (bppv).
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Clinilive | Maringá | Paraná | Brazil | |
| 2 | Irmandade da Santa Casa de Misericórdia de São Paulo | São Paulo | SP | Brazil | |
| 3 | Alergoalpha | Barueri | São Paulo | Brazil | 06454010 |
| 4 | Pesquisare Saude S/S Ltda | Santo André | São Paulo | Brazil | 09080110 |
| 5 | Clinica de Alergia MarttiAntila | Sorocaba | São Paulo | Brazil | 18040425 |
| 6 | ISPEM | São José dos Campos | São Paulo | Brazil | 12243280 |
| 7 | CCBR SP | São Paulo | Brazil | 04063001 |
Sponsors and Collaborators
- Apsen Farmaceutica S.A.
Investigators
- Principal Investigator: Norton Sayeg, PhD, CCBR SP
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- APS 002/2013
- BRA15APS002-2015
- U1111-1149-6768