Effect of V0251 in Acute Vertigo

NCT ID: NCT01583738

Last Updated: 2014-10-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

132 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-04-30

Study Completion Date

2013-04-30

Brief Summary

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Assessment of efficacy and tolerance of a new anti-dizziness drug in acute vertigo.

Detailed Description

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Conditions

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Acute Vertigo

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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V0251

Group Type EXPERIMENTAL

V0251

Intervention Type DRUG

single dose

Placebo

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

single dose

Interventions

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V0251

single dose

Intervention Type DRUG

placebo

single dose

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Men or women
* Age 18 to 70 years
* Acute vertigo attack due to vestibular disorder

Exclusion Criteria

* Signs of brain, brainstem and/or cerebellar dysfunction
* Concomitant central neurological disorder
* Psychogenic vertigo
* Use of ototoxic drugs causing vertigo or dizziness within the last month
* Use of anti-dizziness medications from the onset of symptoms, except if the dosage had been stable for at least 3 months
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pierre Fabre Medicament

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Fakultni Nemocnice Hradec Králové

Hradec Králové, , Czechia

Site Status

Regional Hospital Kladno

Kladno, , Czechia

Site Status

Faculty Hospital Ostrava

Ostrava, , Czechia

Site Status

Faculty Hospital Královské Vinohrady

Prague, , Czechia

Site Status

Faculty Hospital Motol

Prague, , Czechia

Site Status

Thomayer's Teaching Hospital

Prague, , Czechia

Site Status

Strepomrauska Nemocaicni a. S.

Prostějov, , Czechia

Site Status

CHI Elbeuf-Louviers-Val de Reuil

Elbeuf, , France

Site Status

Hôpital Nord

Marseille, , France

Site Status

CHU de Rouen, Hopital Charles Nicolle

Rouen, , France

Site Status

Hôpital Nord

Saint-Etienne, , France

Site Status

Hopital Purpan

Toulouse, , France

Site Status

Universitätsklinikum Aachen

Aachen, , Germany

Site Status

HELIOS Klinikum Berlin-Buch

Berlin, , Germany

Site Status

Park - Klinik Weissensee

Berlin, , Germany

Site Status

Allgemeines Krankenhaus Celle

Celle, , Germany

Site Status

Universitätsklinikum Essen

Essen, , Germany

Site Status

Goethe-University

Frankfurt am Main, , Germany

Site Status

Universitätsklinikum Schleswig-Holstein Campus Lübeck

Lübeck, , Germany

Site Status

University Hospital Mannheim

Mannheim, , Germany

Site Status

Universitätsklinikum München

München, , Germany

Site Status

Semmelweis Egyetem Neurológiai Klinika

Budapest, , Hungary

Site Status

Debreceni Egyetem Orvos- és Egészségtudományi Centrum

Debrecen, , Hungary

Site Status

Petz Aladár Megyei Oktató Kórház

Győr, , Hungary

Site Status

Kaposi Mór Megyei Oktató Kórhaz

Kaposvár, , Hungary

Site Status

Borsod Abaúj Zemplén Megyei Kórház és Egyetemi Oktató Kórház

Miskolc, , Hungary

Site Status

Kanizsai Dorottya Kórház

Nagykanizsa, , Hungary

Site Status

Pécsi Tudományegyetem Általános Orvostudományi Kar

Pécs, , Hungary

Site Status

Soproni Erzsébet Oktató Kórház

Sopron, , Hungary

Site Status

Markusovszky County Hospital

Szombathely, , Hungary

Site Status

Complejo H.Universitario de Badajoz

Badajoz, , Spain

Site Status

Hospital de Poniente

El Ejido, , Spain

Site Status

Hospital Universitario de Getafe

Getafe -Madrid, , Spain

Site Status

Hospital Comarcal San Agustin

Linares, , Spain

Site Status

Hospital Gregorio Marañón

Madrid, , Spain

Site Status

Clinica Universitaria de Navarra

Pamplona, , Spain

Site Status

Complejo Hospitalario de Pontevedra- Montecelo

Pontevedra, , Spain

Site Status

H. Clínico de Salamanca

Salamanca, , Spain

Site Status

Hospital Clinico Universitario

Santiago de Compostela, , Spain

Site Status

Hospital Universitario La Fe

Valencia, , Spain

Site Status

Countries

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Czechia France Germany Hungary Spain

Other Identifiers

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2011-003412-23

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

V0251 IV 202 4A

Identifier Type: -

Identifier Source: org_study_id

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