Clinical Trials Register

Summary
EudraCT Number:	2014-005197-11
Sponsor's Protocol Code Number:	SENC
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:	2015-05-12
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

2014-005197-11

A.3

Full title of the trial

Sugammadex and neurogical effects central

SUGAMMADEX ED EFFETTI NEUROLOGICI CENTRALI

A.3.1

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

Sugammadex and neurogical effects central

SUGAMMADEX ED EFFETTI NEUROLOGICI CENTRALI

A.3.2

Name or abbreviated title of the trial where available

SENC

A.4.1

Sponsor's protocol code number

SENC

A.5.4

Other Identifiers

Name:

not applicable

Number:

non applicabile

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	AZIENDA OSPEDALIERA PAPA GIOVANNI XXIII
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	A.O Papa Giovanni XXIII
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	A.O Papa Giovanni XXIII
B.5.2	Functional name of contact point	USC Anestesia e Rianimazione I
B.5.3	Address:
B.5.3.1	Street Address	Piazza OMS, 1
B.5.3.2	Town/ city	Bergamo
B.5.3.3	Post code	24127
B.5.3.4	Country	Italy
B.5.4	Telephone number	0352675110
B.5.5	Fax number	0352674836
B.5.6	E-mail	abenigni@hpg23.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	No
D.2.1.1.1	Trade name	BRIDION - 100 MG/ML SOLUZIONE INIETTABILE - USO ENDOVENOSO - FLACONCINO (VETRO) TAPPO DI GOMMA E CAPSULA DI CHIUSURA A STRAPPO-5 ML (100MG/ML) 10 X 5 ML
D.2.1.1.2	Name of the Marketing Authorisation holder	N.V. ORGANON
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	Bridion 100 mg/ml
D.3.4	Pharmaceutical form	Solution for injection
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intravenous bolus use (Noncurrent)
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	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
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.IMP: 2
D.1.2 and D.1.3	IMP Role	Comparator
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	No
D.2.1.1.1	Trade name	PROSTIGMINA - 0.5 MG/ML SOLUZIONE INIETTABILE6 FIALE 1 ML
D.2.1.1.2	Name of the Marketing Authorisation holder	MEDA PHARMA S.P.A.
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	prostigmina
D.3.4	Pharmaceutical form	Solution for injection
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intravenous use
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	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
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

patient undergoing elective surgery for which has been indicated only the general anesthesia with tracheal intubation and curarization

pazienti sottoposte ad intervento chirurgico in elezione per le quali è stata indicata la sola anestesia generale con intubazione tracheale e curarizzazione

E.1.1.1

Medical condition in easily understood language

general anesthesia

anestesia generale

E.1.1.2

Therapeutic area

Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	18.0
E.1.2	Level	LLT
E.1.2	Classification code	10002323
E.1.2	Term	Anesthesia general
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

neurogical effects resulting from the use of Sugammadex or Neostigmina

valutare attraverso l'utilizzo di EEG, quali sono i possibili effetti neurologici centrali conseguenti all'impiego di Sugammadex rispetto a quando viene utilizzata Neostigmina per revertire il blocco moderato-profondo indotto da rocuronio nei pazienti adulti

E.2.2

Secondary objectives of the trial

reversal of neuromuscolar blockade induced by rocurobìnium or vecuroniom of adult (TOF ratio>0.9)

la valutazione del dato numerico dell'avvenuta decurarizzaione (TOF ratio>0.9), l'eventuale valutazione degli effetti collaterali, nonchè la valutazione dei costi/tempi operatori

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

women
Aged between 18 and 65 years old
Risk class ASA I-II
indication for tracheal intubation
surgery is indicated only general anesthesia

Donne di età compresa tra 18 e 65 anni
Classe di rischio ASA: I – II
Indicazione ad intubazione tracheale, intervento chirurgico in elezione per il quale sia indicata la sola AG (anestesia generale)

E.4

Principal exclusion criteria

Age below 18 years and 65 years
Acute or chronic renal insufficiency (serum creatinine ≥ 1.5)
Hepatic impairment (PTINR, transaminases, LDH, bilirubin 1.5 times the normal value, PTL <70,000 mm3)
Emergency operations
Neurological disorders in treatment (including Parkinson's)
Known hypersensitivity to sugammadex or neostigmine or excipients contained therein
Subjects with asthma

Età inferiore a 18 anni e superiore a 65 anni
Insufficienza renale acuta o cronica (creatininemia ≥ 1,5)
Insufficienza epatica (PTINR, transaminasi, LDH, bilirubina
di 1,5 volte il valore normale, PTL < 70.000 mm3)
Interventi in urgenza
Soggetti poliallergici
•Patologie neurologiche in trattamento ( tra cui anche il Parkinson)
Ipersensibilità già nota per neostigmina o sugammadex o per gli eccipienti in essi contenuti
Soggetti affetti da asma

E.5 End points

E.5.1

Primary end point(s)

neurogical central effects-evaluation of the appearance of the '"arousal" on the EEG pattern following the administration of the reverse in the absence of variation of the anesthesia plan. L '"arousal" is defined as an abrupt change in the frequency electroencephalographic baseline that includes the appearance of alpha waves and / or theta and / or delta with a greater frequency of 16 Hz and a duration of at least 3 seconds. This frequency change should be observed in both channels.

effetti neurologici- valutazione della comparsa dell’”arousal” sul tracciato elettroencefalografico a seguito della somministrazione del reverse in assenza di variazione del piano anestesiologico. L ’”arousal” è definito come un brusco cambiamento della frequenza elettroencefalografica basale che include la comparsa di onde alfa e/o theta e/o delta con una frequenza maggiore di 16 Hz e una durata di almeno 3 secondi. Tale variazione di frequenza deve essere osservata in entrambi i canali.

E.5.1.1

Timepoint(s) of evaluation of this end point

for 20 minutes plus 20 minutes previous to and following the administration of sugammadex or neostigmin

per 20 minuti + 20 minuti precedente e seguenti la somministrazione di sugammadex o neostigmina

E.5.2

Secondary end point(s)

///

E.5.2.1

Timepoint(s) of evaluation of this end point

///

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

Yes

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

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)

E.7.3

Therapeutic confirmatory (Phase III)

E.7.4

Therapeutic use (Phase IV)

Yes

E.8 Design of the trial

E.8.1

Controlled

Yes

E.8.1.1

Randomised

Yes

E.8.1.2

Open

Yes

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)

Yes

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.8.5.1

Number of sites anticipated in the EEA

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

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

F.1.1.1

In Utero

F.1.1.2

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

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)

Yes

F.1.2.1

Number of subjects for this age range:

F.1.3

Elderly (>=65 years)

F.2 Gender

F.2.1

Female

Yes

F.2.2

Male

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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2015-05-12.

Yes

F.3.3.2

Women of child-bearing potential using contraception

Yes

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

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)

not applicable

non applicabile

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

2015-04-24

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2014-12-18

P. End of Trial
P.	End of Trial Status	Ongoing

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