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| ID | Type | Description | Link |
|---|---|---|---|
| BRA15APS002-2015 | Other Identifier | Apsen | |
| U1111-1149-6768 | Other Grant/Funding Number | World Health Organization |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Meclizine | Experimental | Meclizine 25 mg, tablets |
|
| Dimenhydrinate | Active Comparator | Dimenhydrinate 50 mg, soft Capsgel |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Meclizine | Drug | 25 mg, 3 times per day up to 30 days |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Vertigo Score (VS) | 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. | up to 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of Life Questionnaire DHI - Dizziness Handicap Inventory, validated for the Brazilian population | Evaluation of life quality | up to 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Stanford and Epworth Sleepiness Scale | Evaluation of somnolence (baseline measurement) | up to 30 days |
| Variation of the intensity of each of the 10 symptoms | Evaluation of the variation of the intensity of each of the 10 symptoms that make up VS, along the visits |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Norton Sayeg, PhD | CCBR SP | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinilive | Maringá | Paraná | Brazil | |||
| Alergoalpha |
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| Dimenhydrinate | Drug | 50 mg, 3 times per day up to 30 days |
|
|
| up to 30 days |
| Duration of treatment (days from V0) | Evaluation of the duration of tratement from each group | up to 30 days |
| Adherence rate to treatment | Evaluation of adherence rate from each group throughout the study | up to 30 days |
| Visual analogue scale (VAS) for subjects and for investigators | For the subjective assessment of the participant and investigator's research on the treatment applied in 1,2,3 visits and final (VF); | up to 30 days |
| Participants Percentage with any symptoms classified as moderate (score ≥2) | 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. | Since last Visit |
| Analysis of Adverse Events | 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 | After the signature of SICF |
| Clinical and Physical findings | Evaluation of any changes in clinical / physical assessment findings since baseline | After the signature of SICF |
| Barueri |
| São Paulo |
| 06454010 |
| Brazil |
| Pesquisare Saude S/S Ltda | Santo André | São Paulo | 09080110 | Brazil |
| ISPEM | São José dos Campos | São Paulo | 12243280 | Brazil |
| Irmandade da Santa Casa de Misericórdia de São Paulo | São Paulo | São Paulo | Brazil |
| Clinica de Alergia MarttiAntila | Sorocaba | São Paulo | 18040425 | Brazil |
| CCBR SP | São Paulo | 04063001 | Brazil |
| ID | Term |
|---|---|
| D014717 | Vertigo |
| ID | Term |
|---|---|
| D015837 | Vestibular Diseases |
| D007759 | Labyrinth Diseases |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D008468 | Meclizine |
| D004111 | Dimenhydrinate |
| ID | Term |
|---|---|
| D001559 | Benzhydryl Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D004155 | Diphenhydramine |
| D005021 | Ethylamines |
| D000588 | Amines |
| D013806 | Theophylline |
| D014970 | Xanthines |
| D011688 | Purinones |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |
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