drugset / Trial / NCT02112578

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

NCT02112578

Phase 3 Completed 292 enrolled Apsen Farmaceutica S.A.
RandomizedParallel-groupQuadruple-blindTreatment

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;

Timeline

Start
2016-11-01
Primary completion
2017-04-01
Completion
2017-12-01

Drugs

EvaluationDrugModalityDoseRoute
Comparator Dimenhydrinate Small molecule 50 mg
Subject Meclizine Small molecule 25 mg

Indications