NCT02112578

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

" 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
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 292 (actual)
• Sponsor: Apsen Farmaceutica S.A. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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;

Detailed 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.

Conditions

• Vertigo, Peripheral

Interventions

Type	Name	Description
DRUG	Meclizine	25 mg, 3 times per day up to 30 days
DRUG	Dimenhydrinate	50 mg, 3 times per day up to 30 days

Timeline

• Start date: 2016-11-01
• Primary completion: 2017-04-01
• Completion: 2017-12-01
• First posted: 2014-04-14
• Last updated: 2023-02-08

Locations

7 sites across 1 country: Brazil