E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
analgesia and sedation |
analgesia e sedazione |
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E.1.1.1 | Medical condition in easily understood language |
analgesia and sedation |
analgesia e sedazione |
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E.1.1.2 | Therapeutic area | Diseases [C] - Nervous System Diseases [C10] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10039897 |
E.1.2 | Term | Sedation |
E.1.2 | System Organ Class | 10029205 - Nervous system disorders |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10002182 |
E.1.2 | Term | Analgesia |
E.1.2 | System Organ Class | 100000004865 |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main 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. |
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E.2.2 | Secondary 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.
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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.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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
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• • 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
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E.4 | Principal 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
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• • 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
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E.5 End points |
E.5.1 | Primary end point(s) |
Value of WAT-1 score < 3 more frequently than the placebo group
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punteggio WAT-1 mantenuto entro un valore <3 con una frequenza maggiore rispetto al gruppo placebo. -
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
7 days + 5 days follow-up |
7 giorni + 5 giorni follow-up |
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E.5.2 | Secondary 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
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
7 days + 5 days follow-up |
7 giorni + 5 giorni follow-up |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
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.8.4.1 | Number of sites anticipated in Member State concerned | 3 |
E.8.5 | The trial involves multiple Member States | No |
E.8.5.1 | Number of sites anticipated in the EEA | 3 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial 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
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |