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    Summary
    EudraCT Number:2019-002509-22
    Sponsor's Protocol Code Number:ID2687
    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:2021-05-24
    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 number2019-002509-22
    A.3Full title of the trial
    Impact of totally transdermal sedation in the weaning from remifentanil infusion among critically ill patients undergoing mechanical ventilation: a pilot randomized-controlled Study
    IMPATTO DI UN PROTOCOLLO DI SEDAZIONE TOTALMENTE TRANSDERMICO SULLO SVEZZAMENTO DALL’INFUSIONE CONTINUA DI REMIFENTANIL NEI PAZIENTI CRITICI SOTTOPOSTI A VENTILAZIONE MECCANICA: UNO STUDIO PILOTA RANDOMIZZATO E CONTROLLATO
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Impact of totally transdermal sedation in the weaning from remifentanil infusion among critically ill patients undergoing mechanical ventilation: a pilot randomized-controlled Study
    IMPATTO DI UN PROTOCOLLO DI SEDAZIONE TOTALMENTE TRANSDERMICO SULLO SVEZZAMENTO DALL’INFUSIONE CONTINUA DI REMIFENTANIL NEI PAZIENTI CRITICI SOTTOPOSTI A VENTILAZIONE MECCANICA: UNO STUDIO PILOTA RANDOMIZZATO E CONTROLLATO
    A.3.2Name or abbreviated title of the trial where available
    TOES
    TOES
    A.4.1Sponsor's protocol code numberID2687
    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 SponsorFONDAZIONE POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI IRCCS UNIVERSITA' CATTOLICA DEL SACRO CUORE
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationFONDAZIONE POLICLINICO GEMELLI
    B.5.2Functional name of contact pointDirezione Scientifica Fondazione Po
    B.5.3 Address:
    B.5.3.1Street AddressLargo Agostino Gemelli 8
    B.5.3.2Town/ cityRoma
    B.5.3.3Post code00168
    B.5.3.4CountryItaly
    B.5.4Telephone number0630155701
    B.5.5Fax number0630155701
    B.5.6E-maildirezione.scientifica@policlinicogemelli.it
    D. IMP Identification
    D.IMP: 1
    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 ULTIVA - 5 FLACONI 5 MG
    D.2.1.1.2Name of the Marketing Authorisation holderASPEN PHARMA TRADING LIMITED
    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.3.1Product nameULTIVA
    D.3.2Product code [033003]
    D.3.4Pharmaceutical form Concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNREMIFENTANIL
    D.3.9.1CAS number 132875-61-7
    D.3.9.2Current sponsor codeNA
    D.3.9.3Other descriptive nameREMIFENTANIL
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number3
    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 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.2.1.2Country 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.3.1Product nameALGHEDON
    D.3.2Product code [0390140]
    D.3.4Pharmaceutical form Transdermal patch
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPCutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INN00128200
    D.3.9.1CAS number 437-38-7
    D.3.9.2Current sponsor codeNA
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    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
    Invasive mechanical ventilation is a lifesaving intervention among critically ill patients. However, prolonged ventilation is associated with increased morbidity and mortality. Optimal processes for weaning from ventilation have been studied for many years and have led to evidence-based clinical practice guidelines to facilitate early liberation from invasive mechanical ventilation. It is crucial to avoid prolonged MV, and weaning from the mechanical ventilator should not be delayed.
    Nei pazienti critici l'utilizzo della ventilazione meccanica è spesso necessaria e salva-vita. Nonostante ciò, la ventilazione meccanica prolungata è associata con una aumentata mortalità e morbidità. Sono stati studiati molteplici approcci finalizzati allo svezzamento precoce dalla ventilazione meccanica che hanno portato a linee guida per facilitare la sospensione precoce del supporto ventilatorio invasivo. E' essenziale evitare la ventilazione meccanica prolungata.
    E.1.1.1Medical condition in easily understood language
    Patients admitted to Iintensive care unit and mechanically ventilated.
    Pazienti ricoverati in terapia intensiva e dipendenti dalla ventilazione meccanica.
    E.1.1.2Therapeutic area Diseases [C] - Respiratory Tract Diseases [C08]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10022519
    E.1.2Term Intensive care
    E.1.2System Organ Class 10042613 - Surgical and medical procedures
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    We aim to assess if a TTS fentanyl-based sedation protocol can have an impact on the global Work of Breathing (WOB).
    Determinare se un protocollo di sedazione a base di fentanil transdermico può avere un impatto sul lavoro respiratorio.
    E.2.2Secondary objectives of the trial
    Secondary objectives of the study are strudy the duration of mechanical ventilation in patients receiving TTS-fentanyl compared to remifentanil infusion as well the duration of continuous infusion of opioids, the length of stay in ICU and in hospital
    Obiettivi secondari sono studiare la durata della ventilazione meccanica nei pazienti trattati con fentanil transdermico rispetto al remifentanil in infusione continua, così come per la durata della degenza in terapia intensiva e in ospedale.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Age > 18 yo
    • On Pressure Support Ventilation
    • Analgosedation with continuous infusion of remifentanil lasting 5 days or more
    • Età > 18 anni
    • Ventilati Meccanicamente in Pressure Support Ventilation
    • Remifentanil in infusione continua da 5 giorni o più
    E.4Principal exclusion criteria
    • Hypoxemic respiratory failure (P/F < 200 mmHg);
    • Haemodynamic instability requiring high doses of inotropes or vasopressors;
    • Any condition that may contraindicate the use of remifentanil or TTS-fentanyl;
    • Patient admitted for post-operative monitoring after elective surgery;
    • EAdi catheter contraindicated.
    • Insufficienza respiratoria ipossiemica (P/F < 200 mmHg)
    • Instabilità emodinamica che richiede farmaci inotropi o vasopressori
    • Ogni condizione controindicante l’uso di fentanyl TTS o remifentanil
    • Pazienti ammessi in reparto dopo chirurgia elettiva
    • Controindicazioni al posizionamento di un catetere EAdi
    E.5 End points
    E.5.1Primary end point(s)
    Primary endpoint is to demonstrate that the area under the curve (AUC) of the work of breathing per minute (assessed at 1, 6, 12, 24, 48 and 72 hours) in the intervention group is not higher than the control group
    Dimostrare che l’area sotto la curva (AUC) del lavoro respiratorio per minuto (Valutato a 1, 6, 12, 24, 48 e 72 ore) nel gruppo sperimentale non è maggiore del gruppo controllo
    E.5.1.1Timepoint(s) of evaluation of this end point
    72 hours from enrollment
    72 ore dall'arruolamento
    E.5.2Secondary end point(s)
    Main secondary endpoints include differences in work of breathing per breath, inspiratory effort, delta EAdi, plateau pressure, driving pressure, transpulmonary driving pressure, pulmonary complicance, P0.1, P/F ratio, respiratory rate, tidal volume, arterial blood pressure, heart rate, global duration of mechanical ventilation, length of stay in ICU and in hospital.
    Differenze di lavoro respiratorio per ogni atto, sforzo inspiratorio, delta EAdi, pressione di plateau, driving pressure, driving pressure transpolmonare, compliance polmonare, P0.1, P/F ratio, frequenza respiratoria, tidal volume, pressione arteriosa sistemica, frequenza cardiaca, durata globale della ventilazione meccanica, durata di degenza in ICU e in Ospedale.
    E.5.2.1Timepoint(s) of evaluation of this end point
    from enrollment to the discharge from the hospital for what concern the global duration of mechanical ventilation, length of stay in ICU and in hospital. 72 hours for the others secondary endpoints
    dall'arruolamento alla dimissione dall'ospedale per la durata di degenza in terapia intensiva/ospedale e la durata della ventilazione meccanica. 72 ore per il resto dei parametri
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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 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) 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 Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.4.1Number of sites anticipated in Member State concerned1
    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 years1
    E.8.9.1In the Member State concerned months1
    E.8.9.1In the Member State concerned days1
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months1
    E.8.9.2In all countries concerned by the trial days1
    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: 18
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 6
    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 No
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation Yes
    F.3.3.6Subjects incapable of giving consent personally Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    PATIENTS INTUBATED AND VENTILATED
    PAZIENTI INTUBATI E SEDATI
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state24
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 24
    F.4.2.2In the whole clinical trial 24
    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)
    NORMAL TRATMENTS
    NORMALE PERCORSO DI CURA
    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 Decision2019-11-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-09-12
    P. End of Trial
    P.End of Trial StatusOngoing
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