CompletedPhase 3

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

Brazil292 participantsStarted 2016-11-01

Plain-language 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;

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 pulmo…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Vertigo Score (VS)

Timeframe: up to 30 days

Trial details

NCT IDNCT02112578

SponsorApsen Farmaceutica S.A.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2017-04-01

View on ClinicalTrials.gov More Vertigo, Peripheral trials