MedTrace Logo

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

NCT02112578 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 292

Last updated 2023-02-08

No results posted yet for this study

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;

Conditions

  • Vertigo, Peripheral

Interventions

DRUG

Meclizine

25 mg, 3 times per day up to 30 days

DRUG

Dimenhydrinate

50 mg, 3 times per day up to 30 days

Sponsors & Collaborators

  • Apsen Farmaceutica S.A.

    lead INDUSTRY

Principal Investigators

  • Norton Sayeg, PhD · CCBR SP

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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

Countries

  • Brazil

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02112578 on ClinicalTrials.gov