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

Vertigo, Peripheral Clinical Trial

Official title: " National, Phase III, Radomized, Double-Blind, Double -Dummy, Controlled, Parallel to Evaluate Non Inferiority of Meclin® (Meclizine Chlorhydrate) Versus Dramin® (Dimenhydrinate) Soft Gel Capsules in the Control of Acute Vertigo Symphtoms From Peripheral Origin"

Status Completed

Clinical Trial 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;

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Dizziness
• Vertigo
• Vertigo, Peripheral

• NCT number: NCT02112578
• Study type: Interventional
• Source: Apsen Farmaceutica S.A.
• Status: Completed
• Phase: Phase 3
• Start date: November 1, 2016
• Completion date: December 1, 2017