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    Summary
    EudraCT Number:2018-004078-89
    Sponsor's Protocol Code Number:0001741
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2021-06-04
    Trial 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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2018-004078-89
    A.3Full title of the trial
    RINSING WITH DESAMETASONE VERSUS RINSING WITH BENZIDAMINE IN THE PREVENTION OF MUCOSITES CORRELATED TO CHEMIORADIOTHERAPY IN PATIENTS WITH CANCERS OF THE CERVIC-FACIAL DISTRICT-Studio DEXWASH
    SCIACQUI CON DESAMETASONE VERSUS SCIACQUI CON BENZIDAMINA NELLA PREVENZIONE DELLA MUCOSITE CORRELATA A CHEMIORADIOTERAPIA IN PAZIENTI CON TUMORI DEL DISTRETTO CERVICO-FACCIALE-Studio DEXWASH
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    RINSING WITH DESAMETASONE VERSUS RINSING WITH BENZIDAMINE IN THE PREVENTION OF MUCOSITES CORRELATED TO CHEMIORADIOTHERAPY IN PATIENTS WITH CANCERS OF THE CERVIC-FACIAL DISTRICT-Studio DEXWASH
    SCIACQUI CON DESAMETASONE VERSUS SCIACQUI CON BENZIDAMINA NELLA PREVENZIONE DELLA MUCOSITE CORRELATA A CHEMIORADIOTERAPIA IN PAZIENTI CON TUMORI DEL DISTRETTO CERVICO-FACCIALE-Studio DEXWASH
    A.3.2Name or abbreviated title of the trial where available
    DEXWASH Study
    Studio DEXWASH
    A.4.1Sponsor's protocol code number0001741
    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 SponsorDIPARTIMENTO DI ONCOLOGIA-UNIVERSITA' DEGLI STUDI DI TORINO
    B.1.3.4CountryItaly
    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 supportLaboratorio farmaceutico Milanese
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAOU San Luigi
    B.5.2Functional name of contact pointCentro Data Management
    B.5.3 Address:
    B.5.3.1Street AddressRegione Gonzole 10
    B.5.3.2Town/ cityOrbassano
    B.5.3.3Post code10043
    B.5.3.4CountryItaly
    B.5.6E-mailfrancesca.arizio@unito.it
    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 soldesam
    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.3.1Product namesoldesam
    D.3.2Product code [019499072]
    D.3.4Pharmaceutical form Oral drops, solution
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPBuccal use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNDESAMETASONE
    D.3.9.1CAS number 2392-39-4
    D.3.9.2Current sponsor code019499084
    D.3.10 Strength
    D.3.10.1Concentration unit % percent
    D.3.10.2Concentration typeup to
    D.3.10.3Concentration number5
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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 tantum verde
    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.3.1Product nametantum verde
    D.3.2Product code [256237]
    D.3.4Pharmaceutical form Mouthwash
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPBuccal use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNBENZIDAMINA CLORIDRATO
    D.3.9.1CAS number 132-69-4
    D.3.9.2Current sponsor code190013959
    D.3.10 Strength
    D.3.10.1Concentration unit 1X 100 milligrams/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number150
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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
    patients with cervico-facial neoplasms receiving concomitant chemoradiotherapy.
    pazienti con neoplasie del distretto cervico-faciale sottoposti a trattamento chemioradioterapico concomitante.
    E.1.1.1Medical condition in easily understood language
    patients with cervical tumor treated with chemoradiotherapy
    pazienti con tumore cervico faciale sottoposti a trattamento chemioradioterapico
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level SOC
    E.1.2Classification code 10029104
    E.1.2Term Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The aim of the study is to test the efficacy of rinsings with dexamethasone versus rinsing with benzydamine in reducing the incidence of oral mucositis in patients with cervico-facial neoplasms receiving concomitant chemoradiotherapy.
    Obiettivo dello studio è testare l'efficacia degli sciacqui con desametasone versus sciacqui con benzidamina nel ridurre l'incidenza della mucosite del cavo orale in pazienti con neoplasie del distretto cervico-faciale sottoposti a trattamento chemioradioterapico concomitante.
    E.2.2Secondary objectives of the trial
    432/5000
    • Need to resort to opioid analgesics during treatment (in morphine equivalents);
    • Resolution resolution of grade 3 and 4 mucositis at grade <1;
    • Incidence of mycoses of grade 3 or 4 oral cavity according to the CTCAE 4.03 criteria during treatment;
    • Weight maintenance throughout the duration of treatment;
    • Evaluation of the Quality of Life by completing the validated EORTC QLQ-C30 questionnaire.
    • Necessità di ricorso ad analgesici oppioidi durante il trattamento (in equivalenti di morfina);
    • Tempo di risoluzione della mucosite di grado 3 e 4 a grado < 1;
    • Incidenza di micosi del cavo orale di grado 3 o 4 secondo i criteri CTCAE 4.03 durante il trattamento;
    • Mantenimento di peso durante tutta la durata del trattamento;
    • Valutazione della Quality of Life mediante compilazione del questionario validato EORTC QLQ-C30.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Age over 18 years;

    • Histological diagnosis of cervico-facial cancer;
    • Clinical stage III or IV with indication of concomitant chemoradiotherapy with cisplatin (exclusive or post-surgery adjuvant);
    • Performance status 0-2 according to ECOG;

    • Adequate medullary crasis (hemoglobin> 10.0 g / dL, leukocytes> 3000 / µL, neutrophils> 1500 / µL, platelets
    > 100,000 / ul);

    • Proper renal and hepatic function;

    • Written informed consent according to the procedures of local Ethics Committees.
    • Età superiore a 18 anni;

    • Diagnosi istologica di tumore del distretto cervico- faciale;
    • Stadio clinico III o IV con indicazione a trattamento chemioradioterapico concomitante con cisplatino (esclusivo o adiuvante post-chirurgia);
    • Performance status 0-2 secondo ECOG;

    • Crasi midollare adeguata (emoglobina > 10.0 g/dL, leucociti > 3000/µL, neutrofili >1500/µL, piastrine
    >100.000/µL);

    • Funzione renale ed epatica adeguata;

    • Consenso informato scritto secondo le procedure dei Comitati Etici locali.
    E.4Principal exclusion criteria
    • Presence of distant metastases

    • Previous radiotherapy treatment and / or chemotherapy;
    • Uncontrolled internal pathology;

    • Other anticancer therapies in progress;

    • Active immunological diseases;

    • Concomitant immunosuppressive therapy;

    • Presence of mucositis of the already active oral cavity.
    • Presenza di metastasi a distanza

    • Precedente trattamento radioterapico e/o chemioterapico;
    • Patologia internistica non controllata;

    • Altre terapie antitumorali in corso;

    • Malattie immunologiche attive;

    • Concomitante terapia immunosoppressiva;

    • Presenza di mucosite del cavo orale già attiva.
    E.5 End points
    E.5.1Primary end point(s)
    Reduction in the incidence of oral mucositis in the oral cavity> 2 in the 12 weeks following the beginning of the chemoradiotherapy treatment, according to the CTCAE criteria 4.03
    Riduzione dell’incidenza della mucosite del cavo orale di grado > 2 nelle 12 settimane successive all’inizio trattamento chemioradioterapico, secondo i criteri CTCAE 4.03
    E.5.1.1Timepoint(s) of evaluation of this end point
    12 weeks
    12 settimane
    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 No
    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.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    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) 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 concerned9
    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 Information not present in EudraCT
    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
    LVLS
    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 months24
    E.8.9.1In the Member State concerned days73
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months24
    E.8.9.2In all countries concerned by the trial days73
    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: 120
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 24
    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 state144
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 144
    F.4.2.2In the whole clinical trial 144
    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)
    regular follow up expected for the disease
    regolare follow up previsto per la patologia
    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 Decision2019-03-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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