Vertigo, Peripheral
Conditions
Keywords
Vertigo, Meclizine, dimenhydrinate, Peripheral Origin
Brief summary
* 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;
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.
Interventions
DRUGMeclizine
25 mg, 3 times per day up to 30 days
DRUGDimenhydrinate
50 mg, 3 times per day up to 30 days
Sponsors
Apsen Farmaceutica S.A.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Quality of Life Questionnaire DHI - Dizziness Handicap Inventory, validated for the Brazilian population | up to 30 days | Evaluation of life quality |
Other
| Measure | Time frame | Description |
|---|---|---|
| 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); |
| Stanford and Epworth Sleepiness Scale | up to 30 days | Evaluation of somnolence (baseline measurement) |
| 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 |
| 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. |
| 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 |
Countries
Brazil
Outcome results
None listed