Clinical Trials Register

Summary
EudraCT Number:	2021-000801-25
Sponsor's Protocol Code Number:	RC06/21
National Competent Authority:	Italy - Italian Medicines Agency
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2021-10-12
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

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A. Protocol Information

A.1

Member State Concerned

Italy - Italian Medicines Agency

A.2

EudraCT number

2021-000801-25

A.3

Full title of the trial

Intranasal dexmedetomidine: pilot pharmacokinetics / pharmacodynamics (PK/PD) study in a preterm population undergoing percutaneous central venous catheter placement

Dexmedetomidina intranasale: studio pilota di farmacocinetica/farmacodinamica (PK/PD) in una popolazione di pretermine sottoposti a posizionamento di catetere venoso centrale percutaneo

A.3.1

Title of the trial for lay people, in easily understood, i.e. non-technical, language

Intransal pharmacokinetics of dexmedetomidine in preterm newborns

Farmacocinetica intransale della dexmedetomidina in bambini neonati pretermine

A.3.2

Name or abbreviated title of the trial where available

Pharmacokinetics of dexmedetomidine in preterm infants via the intranasal route

Farmacocinetica della Dexmedetomidina nei neonati pretermine per via intranasale

A.4.1

Sponsor's protocol code number

RC06/21

A.5.4

Other Identifiers

Name:

Acronimo

Number:

RC 06/21

A.7

Trial is part of a Paediatric Investigation Plan

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	IRCCS MATERNO INFANTILE BURLO GAROFOLO
B.1.3.4	Country	Italy
B.3.1 and B.3.2	Status of the sponsor	Non-Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	IRCCS Burlo Garofolo fondi Ricerca corrente
B.4.2	Country	Italy
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	IRCCS Burlo Garofolo di Trieste
B.5.2	Functional name of contact point	SCR Epidemiologia e Biostatistica
B.5.3	Address:
B.5.3.1	Street Address	Via dell'Istria 65/1
B.5.3.2	Town/ city	TRIESTE
B.5.3.3	Post code	34137
B.5.3.4	Country	Italy
B.5.4	Telephone number	0403785297
B.5.5	Fax number	0403785411
B.5.6	E-mail	segreteria.irb@burlo.trieste.it

D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	Dexdor
D.2.1.1.2	Name of the Marketing Authorisation holder	ORION PHARMA Srl
D.2.1.2	Country which granted the Marketing Authorisation	Italy
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	DEXDOR
D.3.2	Product code	[041468024]
D.3.4	Pharmaceutical form	Concentrate for solution for injection/infusion
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intranasal use (Noncurrent)
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	DEXMEDETOMIDINA CLORIDRATO
D.3.9.2	Current sponsor code	Dexmedetomidina
D.3.10	Strength
D.3.10.1	Concentration unit	µg/ml microgram(s)/millilitre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	100
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	Information not present in EudraCT
D.3.11.3.2	Gene therapy medical product	Information not present in EudraCT
D.3.11.3.3	Tissue Engineered Product	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another 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.1.1

Medical condition(s) being investigated

Preterm newborns of less than/or equal to 36 weeks of gestational age who have an umbilical venous or arterial catheter which, for nutritional and/or therapeutic needs, must be replaced by a percutaneous central venous catheter (PICC).

Neonati pretermine di età gestazionale inferiore/uguale a 36 settimane portatori di catetere venoso ombelicale che, per esigenze nutrizionali e/o terapeutiche, si sottoporranno a posizionamento di catetere venoso centrale percutaneo (PICC).

E.1.1.1

Medical condition in easily understood language

Preterm infants who need percutaneous central venous catheter insertion

Neonati pretermine a cui deve essere inserito un catetere venoso centrale percutaneo

E.1.1.2

Therapeutic area

Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutic techniques [E02]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	21.1
E.1.2	Level	LLT
E.1.2	Classification code	10049124
E.1.2	Term	Sedation during medical procedure
E.1.2	System Organ Class	100000004865

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

To define the pharmacokinetics of intranasal dexmedetomidine (after a dose of 3 µg/kg), in preterm babies of less than/or equal to 36 weeks of gestational age, who have an umbilical venous or arterial catheter which, for nutritional and/or therapeutic needs, must be replaced by a percutaneous central venous catheter (PICC). The umbilical catheters will be used for serial blood micro-sampling, thus avoiding additional pain.

L’obiettivo principale di questo studio è di definire la farmacocinetica della dexmedetomidina somministrata per via intranasale, alla dose di 3 µg/kg, in una popolazione di pretermine di età gestazionale inferiore/uguale a 36 settimane, portatori di catetere venoso ombelicale che, per esigenze nutrizionali e/o terapeutiche, devono essere sottoposti a posizionamento di catetere venoso centrale percutaneo (PICC) sfruttando il catetere ombelicale per microprelievi di sangue seriati senza causare dolore.

E.2.2

Secondary objectives of the trial

To define the clinical efficacy (sedation / pain reduction) of dexmedetomidine using the PIPP-R scale (Premature Infant Pain Profile- Revised) during the insertion of a percutaneous venous catheter.

L’obiettivo secondario di questo studio consiste nel definire l’efficacia clinica (sedazione/riduzione del dolore) del farmaco mediante scala PIPP (premature infant pain profile) durante la procedura di posizionamento del catetere venoso percutaneo in concomitanza alla raccolta ematica per l’analisi farmacocinetica.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Gestational age from 28 to 36 weeks with a minimum weight of 1 kg (50° percentile at 28 weeks of GA)
2. Patent umbilical catheter already in place (venous or arterial)
3. Need for a percutaneous venous catheter for nutritional and/or therapeutic purposes in elective conditions
4. Consent to the study participation and to the off-label use of dexmedetomidine
5. Drug therapies not included in the exclusion criteria

1. Età gestazionale da 28 a 36 settimane con un peso minimo di 1 kg (50° percentile a 28 settimane di GA)
2. Presenza di catetere ombelicale refluente (venoso o arterioso)
3. Necessità di un catetere venoso percutaneo per scopi nutrizionali e/o terapeutici in condizioni elettive
4. Consenso alla partecipazione allo studio e all'uso off-label della dexmedetomidina
5. Terapie farmacologiche non incluse nei criteri di esclusione

E.4

Principal exclusion criteria

1. Need for a percutaneous venous catheter in emergency conditions
2. Cardiac instability (such as arrhythmias or significant cardiac dysfunctions), hemodynamically significant congenital heart disease
3. Bradycardia at the time of enrolment with HR < 100
4. Hypotension at the time of enrolment with mean BP less than GA
5. Beta blocker or digoxin therapy or drugs acting on the atrio-ventricular node
6. IVH 3-4
7. Administration of sedative or anaesthetic drugs in the 8 hours prior to enrolment
8. Any nasal obstruction that might impair the intranasal drug administration/absorption
9. Craniofacial anomalies associated with difficulty in ventilation through a mask or intubation
10. Liver disease characterised by AST > 100 U/L; ALT > 80 U/L; BD > 2 mg/dL or >20% of total bilirubin

1. Necessità di un catetere venoso percutaneo in condizioni di emergenza
2. Instabilità cardiaca nota (aritmie o disfunzioni cardiache significative, cardiopatia congenita emodinamicamente significativa);
3. Bradicardia al momento dell'arruolamento con HR < 100;
4. Ipotensione al momento dell'arruolamento con pressione sanguigna media minore rispetto al valore dell’età gestazionale
5. Terapia con betabloccanti o digossina o farmaci che agiscono sul nodo atrio-ventricolare;
6. IVH 3-4°;
7. Somministrazione di farmaci sedativi o anestetici nelle 8 ore precedenti l’arruolamento;
8. Qualsiasi ostruzione nasale che potrebbe compromettere la somministrazione/assorbimento intranasale del farmaco;
9. Anomalie cranio-facciali associate a difficoltà di ventilazione tramite maschera o intubazione;
10. Malattia epatica caratterizzata da AST > 100 U/L; ALT > 80 U/L; BD > 2 mg/dL o >20% della bilirubina totale

E.5 End points

E.5.1

Primary end point(s)

The aim of the study is to define the pharmacokinetics of dexmedetomidine, administered intranasally, in preterm infants.

L'obiettivo dello studio è quello di definire la farmacocinetica della dexemedetodimina somministrata per via intranasale nei neonati pretermine.

E.5.1.1

Timepoint(s) of evaluation of this end point

12 hours

12 ore

E.5.2

Secondary end point(s)

- The clinical efficacy of the drug (pharmacodynamics) expressed by the score of the PIPP scale, assessed during the procedure according to the blood concentration of the drug; The variation of vital parameters (heart rate, oxygen saturation, blood pressure) associated with the concentration of the drug

- L'efficacia clinica del farmaco (farmacodinamica) espressa dal punteggio della scala PIPP, valutata durante la procedura in base alla concentrazione ematica del farmaco; La variazione dei parametri vitali (frequenza cardiaca, saturazione di ossigeno, pressione sanguigna) associati alla concentrazione del farmaco

E.5.2.1

Timepoint(s) of evaluation of this end point

30 minutes; 12 hours

30 minuti; 12 ore

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

E.6.3

Therapy

E.6.4

Safety

E.6.5

Efficacy

E.6.6

Pharmacokinetic

Yes

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

E.6.13

Others

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

Yes

E.7.3

Therapeutic confirmatory (Phase III)

E.7.4

Therapeutic use (Phase IV)

E.8 Design of the trial

E.8.1

Controlled

E.8.1.1

Randomised

E.8.1.2

Open

E.8.1.3

Single blind

E.8.1.4

Double blind

E.8.1.5

Parallel group

E.8.1.6

Cross over

E.8.1.7

Other

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

E.8.2.2

Placebo

E.8.2.3

Other

E.8.2.4

Number of treatment arms in the trial

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

E.8.4.1

Number of sites anticipated in Member State concerned

E.8.5

The trial involves multiple Member States

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

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

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

E.8.9 Initial estimate of the duration of the trial

E.8.9.1

In the Member State concerned years

E.8.9.1

In the Member State concerned months

E.8.9.1

In the Member State concerned days

E.8.9.2

In all countries concerned by the trial years

E.8.9.2

In all countries concerned by the trial months

E.8.9.2

In all countries concerned by the trial days

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

Yes

F.1.1.1

In Utero

F.1.1.2

Preterm newborn infants (up to gestational age < 37 weeks)

Yes

F.1.1.2.1

Number of subjects for this age range:

F.1.1.3

Newborns (0-27 days)

F.1.1.4

Infants and toddlers (28 days-23 months)

F.1.1.5

Children (2-11years)

F.1.1.6

Adolescents (12-17 years)

F.1.2

Adults (18-64 years)

F.1.3

Elderly (>=65 years)

F.2 Gender

F.2.1

Female

Yes

F.2.2

Male

Yes

F.3 Group of trial subjects

F.3.1

Healthy volunteers

F.3.2

Patients

Yes

F.3.3

Specific vulnerable populations

Yes

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

F.3.3.3

Pregnant women

F.3.3.4

Nursing women

F.3.3.5

Emergency situation

F.3.3.6

Subjects incapable of giving consent personally

Yes

F.3.3.6.1

Details of subjects incapable of giving consent

Newborns

Pazienti neonati

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

F.4.2

For a multinational trial

F.4.2.1

In the EEA

F.4.2.2

In the whole clinical trial

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

N. Review by the Competent Authority or Ethics Committee in the country concerned

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2021-12-10

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2021-08-03

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2023-08-11

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