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    Summary
    EudraCT Number:2011-004025-27
    Sponsor's Protocol Code Number:Antivert1-B09_PE_V1.0
    National Competent Authority:Czechia - SUKL
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2012-11-23
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedCzechia - SUKL
    A.2EudraCT number2011-004025-27
    A.3Full title of the trial
    Efficacy and safety of a fixed combination of cinnarizine 20 mg and dimenhydrinate 40 mg vs betahistine dihydrochloride 16 mg in patients with vertigo of peripheral origin. A multi-centre, double-blind, randomised, active-controlled, stratified two-parallel group clinical study
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Efficacy and safety of a fixed combination of cinnarizine 20 mg and dimenhydrinate 40 mg vs betahistine dihydrochloride 16 mg in patients with inner ear vertigo.
    A.4.1Sponsor's protocol code numberAntivert1-B09_PE_V1.0
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorHENNIG ARZNEIMITTEL GmbH & Co. KG
    B.1.3.4CountryGermany
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportHENNIG ARZNEIMITTEL GmbH & Co. KG
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationHENNIG ARZNEIMITTEL GmbH & Co. KG
    B.5.2Functional name of contact pointClinical Trials Information
    B.5.3 Address:
    B.5.3.1Street AddressLiebigstraße 1-2
    B.5.3.2Town/ cityFlörsheim am Main
    B.5.3.3Post code65439
    B.5.3.4CountryGermany
    B.5.4Telephone number+4961455080
    B.5.5Fax number+496145508158
    B.5.6E-mailclinical-trials@hennig-am.de
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Arlevert®
    D.2.1.1.2Name of the Marketing Authorisation holderHENNIG ARZNEIMITTEL GmbH & Co. KG
    D.2.1.2Country which granted the Marketing AuthorisationCzech Republic
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCINNARIZINE
    D.3.9.1CAS number 298-57-7
    D.3.9.3Other descriptive nameCINNARIZINE
    D.3.9.4EV Substance CodeSUB06302MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNDIMENHYDRINATE
    D.3.9.1CAS number 523-87-5
    D.3.9.3Other descriptive nameDIMENHYDRINATE
    D.3.9.4EV Substance CodeSUB07159MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number40
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Vertisan 16 mg tablety
    D.2.1.1.2Name of the Marketing Authorisation holderHENNIG ARZNEIMITTEL GmbH & Co. KG
    D.2.1.2Country which granted the Marketing AuthorisationCzech Republic
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNBETAHISTINE DIHYDROCHLORIDE
    D.3.9.1CAS number 5638-76-6
    D.3.9.3Other descriptive nameBETAHISTINE DIHYDROCHLORIDE
    D.3.9.4EV Substance CodeSUB25919
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number16
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Vertigo of peripheral origin
    E.1.1.1Medical condition in easily understood language
    Vertigo originated in the inner ear
    E.1.1.2Therapeutic area Diseases [C] - Ear, nose and throat diseases [C09]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 15.0
    E.1.2Level LLT
    E.1.2Classification code 10031615
    E.1.2Term Other and unspecified peripheral vertigo
    E.1.2System Organ Class 10013993 - Ear and labyrinth disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10058708
    E.1.2Term Rotatory vertigo
    E.1.2System Organ Class 10013993 - Ear and labyrinth disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10047344
    E.1.2Term Vertigo labyrinthine
    E.1.2System Organ Class 10013993 - Ear and labyrinth disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10034641
    E.1.2Term Peripheral vertigo, unspecified
    E.1.2System Organ Class 10013993 - Ear and labyrinth disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 15.0
    E.1.2Level LLT
    E.1.2Classification code 10032379
    E.1.2Term Other peripheral vertigo
    E.1.2System Organ Class 10013993 - Ear and labyrinth disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The main objective is to demonstrate that the antivertiginous efficacy of the fixed combination cinnarizine/dimenhydrinate is non-inferior to betahistine dihydrochloride 16 mg in patients suffering from vertigo of peripheral origin.
    E.2.2Secondary objectives of the trial
    Changes in Mean Vertigo Score after 1 week of therapy
    Changes in the intensity of 6 unprovoked vertigo symptoms and of vertigo in consequence of 6 various triggering factors, of vegetative and other concomitant symptoms and of further complaints during the treatment
    Changes in parameters of vestibulo-spinal and vestibulo-ocular tests during the treatment
    Evaluation of global efficacy by both the investigator and the patient (5-point scale)
    Evaluation of the patient’s ability to cope with daily activities (3-point scale)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    caucasian
    written Informed Consent of the patient
    age ≥ 18
    patient has vertigo sensations of peripheral-vestibular origin, e.g. Menière-like symptoms
    E.4Principal exclusion criteria
    simultaneous participation in another clinical study
    patient did not voluntarily sign the informed consent form
    intake of antivertiginous or cerebrovascularly active medication that cannot be discontinued
    known allergic reactions to one of the active substances of the study medication (cinnarizine, dimenhydrinate and/or betahistine dihydrochloride)
    known hypersensitivity to various medicaments
    suspicion of alcohol and/or drug abuse
    psychiatric diseases, insanity
    epilepsy or convulsive fits
    acute infections
    severe chronic or terminal diseases (cancer, tuberculosis)
    any disease that could affect absorption, metabolism or elimination of the study medication
    acute poisoning
    suspected pregnancy / nursing period / women of child-bearing potential, if no safe contraception can be guaranteed during the study
    chronic inflammatory middle ear diseases
    Parkinson’s disease
    suspected compressive intracranial processes
    suspected narrow-angle glaucoma
    suspected prostate adenoma with formation of residual urine in the bladder
    severe renal insufficiency
    chronic liver disease
    treatment with aminoglycosidic antibiotics
    treatment with monoaminooxidase inhibitors, tricyclic antidepressants, para-sympatholytics, glucocorticoids and/or heparin that cannot be discontinued
    phaeochromocytoma
    peptic ulcer
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is the change in the Mean Vertigo Score (MVS) from Baseline to Week 4, defined as the mean of the intensities of six unprovoked vertigo symptoms (dystasia and walking unsteadiness, staggering, rotary sensation, tendency to fall, lift sensation and blackout) and of vertigo in consequence of six triggering factors (change of position, bowing, getting up, driving by car/train, head movements, and eye movement), as subjectively judged by the patient.
    E.5.1.1Timepoint(s) of evaluation of this end point
    baseline and after 4 weeks of treatment
    E.5.2Secondary end point(s)
    Changes in Mean Vertigo Score after 1 week of therapy
    Changes in the intensity of 6 unprovoked vertigo symptoms and of vertigo in consequence of 6 various triggering factors, of vegetative and other concomitant symptoms and of further complaints during the treatment
    Changes in parameters of vestibulo-spinal and vestibulo-ocular tests during the treatment
    Evaluation of global efficacy by both the investigator and the patient (5-point scale)
    Evaluation of the patient’s ability to cope with daily activities (3-point scale)
    E.5.2.1Timepoint(s) of evaluation of this end point
    baseline, after 1 week and after 4 weeks of treatment
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic Yes
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    Non-Inferiority Design
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA5
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Austria
    Bulgaria
    Czech Republic
    Russian Federation
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 178
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 46
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state72
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 182
    F.4.2.2In the whole clinical trial 224
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    Investigational product and comparator can be prescribed by the Clinical Investigator.
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2013-02-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-12-05
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2015-04-14
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