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    EudraCT Number:2013-003268-29
    Sponsor's Protocol Code Number:OTI2013
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2013-08-27
    Trial results
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    A. Protocol Information
    A.1Member State ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2013-003268-29
    A.3Full title of the trial
    Hyperbaric oxygen therapy in the treatment of sudden hydiopatic sensorineural hearing loss
    L'ossigenoterapia iperbarica nella sordità improvvisa idiopatica
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    The hyperbaric oxygen therapy in the sudden hearing loss of unknown origin
    L'ossigenoterapia iperbarica nella sordità improvvisa da causa sconosciuta
    A.3.2Name or abbreviated title of the trial where available
    Hyperbaric oxygen therapy in sudden SNHL
    Ossigenoterapia iperbarica nella sordità improvvisa
    A.4.1Sponsor's protocol code numberOTI2013
    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 SponsorAUSL Piacenza
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportAzienda USL Piacenza
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAzienda USL Piacenza
    B.5.2Functional name of contact pointServizio Ricerca e Innovazione
    B.5.3 Address:
    B.5.3.1Street AddressVia Taverna 49
    B.5.3.2Town/ cityPiacenza
    B.5.3.3Post code29121
    B.5.4Telephone number00390523302724
    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. name Ossigeno
    D. of the Marketing Authorisation holderSapio Produzioni Idrogeno Ossigeno S.r.l.
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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 Gas and solvent for dispersion for injection/infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPInhalation use
    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. cell therapy medicinal product No
    D. therapy medical product No
    D. Engineered Product No
    D. ATIMP (i.e. one involving a medical device) No
    D. 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 Yes
    D. medicinal product typeMedical natural gas
    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
    Sudden Sensorineural Hearing Loss
    Ipoacusia improvvisa idiopatica
    E.1.1.1Medical condition in easily understood language
    Sensorineural hearing loss that begin suddenly
    Sordità neurosensoriale che compare improvvisamente
    E.1.1.2Therapeutic area Diseases [C] - Ear, nose and throat diseases [C09]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the rate of patients who recover at least the 50% of their hearing loss after hyperbaric oxygen therapy (HOT) is given
    L'obiettivo primario dello studio è: valutare l’efficacia dell’Ossigeno Terapia Iperbarica (OTI) associata a terapia farmacologica rispetto alla sola terapia farmacologica in termini di dimezzamento della perdita uditiva dopo un mese dall’esordio di Sordità Improvvisa Idiopatica (SII).
    E.2.2Secondary objectives of the trial
    To evaluate the rate of patients who doesn’t recover or recover partially or completely after HOT. To evaluate the quality of life in terms of auditory, tinnitus and dizziness disability after HOT. To evaluate the HOT safety
    Obiettivi secondari sono: il recupero uditivo completo o marginale, la qualità di vita del paziente (QoL) in termini di disabilità uditiva percepita, acufene e disequilibrio ed infine la sicurezza dell’OTI.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - age > 18 yrs
    - unilateral sensorineural hearing loss appeared in less than 72 hrs
    - hearing threshold equal or greater than 30 dB at three or more adjacent frequencies
    - therapy starting maximum 7 days after the symptoms appearance
    - signed informed consent
    età superiore a 18 anni
    - ipoacusia neurosensoriale unilaterale idiopatica (il riferimento è dato dal profilo audiometrico dell’orecchio controlaterale)
    - ipoacusia insorta improvvisamente (in meno di 72 ore)
    - perdita uditiva non inferiore a 30 dB in almeno tre frequenze audiometriche contigue (il riferimento è dato dal profilo audiometrico dell’orecchio controlaterale). Le frequenze audiometriche considerate sono 250-500-1000-2000-4000-8000 Hz.
    - presa in carico ed inizio del trattamento entro 7 giorni dall’insorgenza dei sintomi
    - firma del consenso informato
    E.4Principal exclusion criteria
    - Middle ear disease
    - Previous sudden hearing loss (relapsing hearing loss)
    - Definite diagnosis (definite viral infection, Meniere’s disease, acoustic neuroma, ototoxyc drugs, multiple sclerosys)
    - High embolic risk from cardiac or vascular diseases
    - HOT contraindications (pneumotorax, upper respiratory tract infections, seizures, chemotherapy, psycosis)
    - Diabetes
    - Gastric ulcer
    - Pregnancy
    - No informed consent
    - Concomitante patologia dell’orecchio medio (rilevata dal timpanogramma e dall’otoscopia)
    - Precedenti anamnestici di SI (forme recidivanti)
    - Chiara diagnosi eziologica (infezione virale clinicamente evidente, come parotite etc., malattia di Ménière, neurinoma del nervo acustico, uso di farmaci ototossici, sclerosi multipla)
    - Concomitanza di chiara malattia aterosclerotica tromboembolica (ad esempio attacchi ischemici transitori, ictus cerebri, ischemia coronarica acuta, malattia valvolare emboligena)
    - Situazioni in cui l’OTI può rappresentare un ulteriore rischio: pneumotorace spontaneo, gravi infezioni del tratto respiratorio superiore, epilessia non trattata o non sufficientemente trattata farmacologicamente, concomitante trattamento con chemioterapici, malattia psicotica
    - Diabete mellito
    - Ulcera gastrica
    - Gravidanza
    - Rifiuto di collaborare o di firmare il consenso informato
    E.5 End points
    E.5.1Primary end point(s)
    To evaluate the rate of patients who recover at least the 50% of their hearing loss after HOT. The improvement is defined as a reduction of hearing threshold average at frequencies 500-1000-2000-4000 Hz
    L’indicatore primario è definito dal dimezzamento della perdita uditiva entro un mese dall’esordio dei sintomi ovvero il recupero della perdita audiometrica superiore al 50% rispetto ai valori basali.
    E.5.1.1Timepoint(s) of evaluation of this end point
    One month after therapy beginning
    Un mese dopo l’inizio del trattamento
    E.5.2Secondary end point(s)
    - rate of patients with total hearing loss recovery after HOT
    - rate of patients with partial recovery of hearing loss (25-50%) after HOT
    - rate of patients with no recovery after HOT
    - residual hearing disability (final score at Spatial Hearing Questionnaire - SHQ)
    - hearing disability recovery (final vs initial score difference at SHQ)
    - residual tinnitus disability (final score at Iowa Tinnitus Handicap Questionnaire - ITHQ)
    - tinnitus disability recovery (final vs initial score difference at ITHQ)
    - residual tinnitus loudness estimated with Visual Analog Scale (VAS)
    - tinnitus loudness recovery (final vs initial loudness estimated with VAS)
    - residual dizziness disability (final score at Dizziness Handicap Inventory - DHI)
    - dizziness disability recovery (final vs initial score difference at DHI)
    - severe therapy complications (requiring treatment’s interruption)
    - mild therapy complications (not requiring interruption)
    - recupero uditivo totale: definito dal completo recupero della perdita audiometrica (100%)
    - recupero uditivo parziale: definito da un recupero della soglia audiometrica compresa fra il 25 ed il 50%
    - assenza di recupero
    - disabilità uditiva residuale: definita dal punteggio del questionario SHQ somministrato al controllo finale dopo un mese dall’esordio dei sintomi
    - recupero di disabilità uditiva: definito dalla differenza dei punteggi del questionario SHQ somministrato dopo un mese e prima del trattamento
    - disabilità acufene residuale: definito dal punteggio al questionario ITHQ somministrato al controllo finale dopo un mese dall’esordio dei sintomi
    - recupero disabilità acufene: definito dalla differenza dei punteggi al questionario ITHQ somministrato dopo un mese e prima del trattamento
    - loudness acufene residuale: punteggio rilevato con VAS dopo un mese dall’esordio dei sintomi
    - recupero loudness acufene: definite dalla differenza dei punteggi rilevati con VAS dopo un mese e prima del trattamento
    - disabilità vertiginosa residuale: definita dal punteggio al questionario DHI somministrato al controllo finale dopo un mese dall’esordio dei sintomi
    - recupero di disabilità vertiginosa: definito dalla differenza dei punteggi al questionario DHI somministrato dopo un mese e prima del trattamento
    - complicanze: le complicanze sono distinte in 2 categorie, ossia le forme Lievi e quelle Gravi. Le forme Lievi non comportano interruzione del trattamento. Quelle gravi invece comportano l’interruzione dello stesso
    E.5.2.1Timepoint(s) of evaluation of this end point
    One month after therapy beginning
    Un mese dopo l’inizio del trattamento
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Yes
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy No
    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 No
    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. 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 No
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    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 concerned10
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    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
    ultima visita, ultimo paziente
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months1
    E.8.9.1In the Member State concerned days
    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: 160
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 80
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state240
    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)
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2013-10-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-06-21
    P. End of Trial
    P.End of Trial StatusOngoing
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