Non Inferiority of Meclin® (Meclizine Chlorhydrate) Versus Dramin® (Dimenhydrinate) in Control of… (NCT02112578) | Clinical Trial Compass
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 range18 Years – 65 Years
SexALL
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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…