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    Summary
    EudraCT Number:2015-002114-80
    Sponsor's Protocol Code Number:TIP-15-01
    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:2019-01-02
    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 number2015-002114-80
    A.3Full title of the trial
    Efficacy and safety of dexmedetomidine during weaning from analgesia and sedation in Pediatric Intensive Care Unit. A multicenter, double-blind, randomized controlled trial.
    Efficacia e sicurezza della Dexmedetomidina
    durante lo svezzamento dei farmaci analgesici e sedativi
    in Terapia Intensiva Pediatrica.
    Studio clinico spontaneo interventistico con farmaco, multicentrico, randomizzato, controllato, in doppio cieco
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Efficacy and safety of dexmedetomidine during weaning from analgesia and sedation in Pediatric Intensive Care Unit. A multicenter, double-blind, randomized controlled trial.
    Efficacia e sicurezza della Dexmedetomidina
    durante lo svezzamento dei farmaci analgesici e sedativi
    in Terapia Intensiva Pediatrica.
    Studio clinico spontaneo interventistico con farmaco, multicentrico, randomizzato, controllato, in doppio cieco
    A.3.2Name or abbreviated title of the trial where available
    TIP-15-01
    TIP-15-01
    A.4.1Sponsor's protocol code numberTIP-15-01
    A.5.4Other Identifiers
    Name:TIP-15-01Number:TIP-15-01
    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 SponsorAOU DI BOLOGNA POLICLINICO S.ORSOLA-MALPIGHI
    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 supportOrion Pharma
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAOU DI BOLOGNA POLICLINICO S.ORSOLA-MALPIGHI
    B.5.2Functional name of contact pointUO ANESTESIOLOGIA E RIANIMAZIONE (C
    B.5.3 Address:
    B.5.3.1Street AddressVIA ALBERTONI 15
    B.5.3.2Town/ cityBOLOGNA
    B.5.3.3Post code40138
    B.5.3.4CountryItaly
    B.5.4Telephone number0512143650
    B.5.5Fax number051636690
    B.5.6E-mailmariacristina.mondardini@aosp.bo.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 DEXDOR - 100 MCG/ML - CONCENTRATO PER SOLUZIONE PER INFUSIONE - USO ENDOVENOSO - (FIALA (VETRO) - 2 ML 25 FIALE
    D.2.1.1.2Name of the Marketing Authorisation holderORION CORPORATION
    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 nameDEXDOR
    D.3.2Product code DEXDOR
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMP
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNDEXMEDETOMIDINA CLORIDRATO
    D.3.9.2Current sponsor codeDEXMEDETOMIDINA CLORIDRATO
    D.3.9.3Other descriptive nameDEXMEDETOMIDINA CLORIDRATO
    D.3.10 Strength
    D.3.10.1Concentration unit µg/ml microgram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    analgesia and sedation
    analgesia e sedazione
    E.1.1.1Medical condition in easily understood language
    analgesia and sedation
    analgesia e sedazione
    E.1.1.2Therapeutic area Diseases [C] - Nervous System Diseases [C10]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10039897
    E.1.2Term Sedation
    E.1.2System Organ Class 10029205 - Nervous system disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10002182
    E.1.2Term Analgesia
    E.1.2System Organ Class 100000004865
    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 efficacy of dexmedetomidine infusion during weaning from analgesia and sedation in reducing withdrawal syndrome in Pediatric Intensive Care (PICU).
    Stabilire l’efficacia della dexmedetomidina somministrata in TIP durante lo svezzamento dei farmaci analgesici e sedativi, nel ridurre la comparsa della sindrome d’astinenza.
    E.2.2Secondary objectives of the trial
    1. Evaluate safety of dexmedetomidine infusion during weaning from analgesia and sedation in PICU.
    2. Evaluate efficacy in reducing lenght (days)of weaning from analgesia and sedation
    3. Evaluate efficacy in reducing lenght (days)of ventilation
    4. Evaluate efficacy in reducing lenght (days)of PICU stay
    5. Evaluate whether efficacy of dexmedetomidine is different between age groups, sex, race, severity of scoring systems, length of analgosedationtreatment before start of weaning.
    6. Evaluate the average effective dose.
    1) Stabilire la sicurezza della dexmedetomidina somministrata in TIP durante lo svezzamento dei farmaci analgesici e sedativi.
    2) Stabilire l’efficacia nel ridurre la durata (in gg) dello svezzamento da farmaci analgesici e sedativi.
    3) Stabilire l’efficacia nel ridurre la durata (in gg) della ventilazione.
    4) Stabilire l’efficacia nel ridurre la durata (in gg) della degenza in TIP.
    5) Stabilire se l’efficacia della dexmedetomidina è diversa in relazione alla fascia d’età del pz, sesso, razza, score di gravità all’ingresso, durata in gg dell’analgosedazione prima dell’inizio dello svezzamento.
    6) Stabilire il dosaggio medio efficace.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • • Continuous analgosedation treatment ongoing for at least 5 days
    • Clinical condition consistent with start of narcotic weaning
    • Mechanical ventilation
    • Neonates born at ≥ 36 weeks of gestational age
    • Postnatal age > 7 days
    • Age between 7 days and 18 years
    • For Patients of childbearing potential is scheduled Beta-HCG and enrolment is subordinated to the negative outcome of the test
    • Informed consent obtained by parents/legal tutors
    • • trattamento analgesico-sedativo continuativo da almeno 5 gg
    • condizione clinica compatibile con l’avvio dello svezzamento da analgesici e sedativi
    • ventilazione meccanica
    • neonati nati conetà gestazionale (EG) ≥ 36 settimane
    • neonati con età postnatale > 7 giorni
    • età compresa tra 7 gg e 18 anni
    • Per le pazienti potenzialmente fertili (almeno un ciclo mestruale) è prevista l’esecuzione del test Beta-HCG e l’arruolamento allo studio è subordinato all’esito negativo del test
    • consenso informato scritto e firmato dai genitori/tutori legali
    E.4Principal exclusion criteria
    • • Severe bradycardia
    • Severe hypotension
    • Heart block of second/third degree
    • prolonged fever and malignant hyperthermia risk
    • concomitant antihypertensive (amlodipine, atenolol, captopril, carvedilol, digoxin, labetalol, metoprolol, nicardipine, nitroglycerin, and propranolol) and/or infusion therapy with one or more inotropic agents.
    • Known or suspected hypersensitivity to dexmedetomidine or to others drug of the same pharmacological class
    • Severe clinical conditions that contraindicate the participation
    • Previous use of the experimental drug or clonidine or other alpha-agonist
    • • bradicardia severa
    • ipotensione severa
    • blocco cardiaco grado 2 o 3
    • febbre prolungata di origine sconosciuta e sensibilità all’ipertermia maligna
    • presenza di concomitanti trattamenti antipertensivi (ß-bloccanti, calcio-antagonisti, ACE-inibitori, digossina, nicardipina, nitroglicerina) e/o di terapia infusionale con 2 o più inotropi
    • nota o sospetta ipersensibilità al farmaco od alla classe farmacologica in studio
    • pazienti con gravi condizioni cliniche che, a giudizio dello sperimentatore, controindicano la partecipazione del paziente allo studio
    • utilizzo del farmaco sperimentale,diclonidina o di altro alfa-agonistaprima dell’inclusione nello studio
    • stato di gravidanza
    E.5 End points
    E.5.1Primary end point(s)
    Value of WAT-1 score < 3 more frequently than the placebo group

    punteggio WAT-1 mantenuto entro un valore <3 con una frequenza maggiore rispetto al gruppo placebo. -

    E.5.1.1Timepoint(s) of evaluation of this end point
    7 days + 5 days follow-up
    7 giorni + 5 giorni follow-up
    E.5.2Secondary end point(s)
    - In case of WAT-1 score ≥ 3, a reduction of one or more points of the score value in the subsequent control, with a greater frequency than the placebo group - Decrease in rescue doses for acute withdrawal crisis compared to the placebo group - Reducing the number oftemporarysuspensionof weaning, comparedto the placebo group. - monitoring and the recording of adverse events and serious adverse events. - monitoring and recording of hemodynamic parameters
    in caso di punteggio WAT-1 ≥ 3, al controllo successivo una riduzione di 1 o più punti del valore precedente, con una frequenza maggiore rispetto al gruppo placebo. - riduzione del numero delle dosi rescue somministrate per “crisi acuta”, rispetto al gruppo placebo. - riduzione del numero delle volte in cui è stato necessario sospendere temporaneamente lo svezzamento, rispetto al gruppo placebo. - monitoraggio e registrazione degli eventi avversi e degli eventi avversi seri - monitoraggio e registrazione dei parametri emodinamici

    E.5.2.1Timepoint(s) of evaluation of this end point
    7 days + 5 days follow-up
    7 giorni + 5 giorni follow-up
    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 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 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 No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    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 concerned3
    E.8.5The trial involves multiple Member States No
    E.8.5.1Number of sites anticipated in the EEA3
    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 months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 1
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Yes
    F.1.1.2.1Number of subjects for this age range: 2
    F.1.1.3Newborns (0-27 days) Yes
    F.1.1.3.1Number of subjects for this age range: 4
    F.1.1.4Infants and toddlers (28 days-23 months) Yes
    F.1.1.4.1Number of subjects for this age range: 8
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 126
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 16
    F.1.2Adults (18-64 years) No
    F.1.3Elderly (>=65 years) No
    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 No
    F.3.3.6Subjects incapable of giving consent personally Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Subjects under age incpable of giving consent personally
    Minori incapaci di dare il proprio consenso.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state160
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 160
    F.4.2.2In the whole clinical trial 160
    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 Patient Care.
    Normale percorso assistenziale.
    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 Decision2016-10-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-03-14
    P. End of Trial
    P.End of Trial StatusOngoing
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