Clinical Trials Register

Summary
EudraCT Number:	2014-002021-35
Sponsor's Protocol Code Number:	ANR-1/14
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:	2014-07-14
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

2014-002021-35

A.3

Full title of the trial

Decurarization After Thoracic Anesthesia - A prospective multicenter double-blind randomized trial comparing sugammadex vs neostigmine reversal after thoracic anesthesia

Decurarization After Thoracic Anesthesia - Studio prospettico multicentrico randomizzato in doppio cieco per confrontare la gestione del reversal del blocco neuromuscolare con sugammadex e neostigmina dopo chirurgia toracica

A.3.1

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

Prospective trial comparing sugammadex vs neostigmine reversal of neuromuscular block after thoracic anesthesia

Studio prospettico per confrontare l'antagonismo del blocco neuromuscolare con sugammadex rispetto a neostigmina dopo anestesia toracica

A.3.2

Name or abbreviated title of the trial where available

DATA Trial

Studio DATA

A.4.1

Sponsor's protocol code number

ANR-1/14

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	Fondazione IRCCS Istituto Nazionale dei Tumori
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	Fondazione IRCCS Istituto Nazionale dei Tumori
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	Fondazione IRCCS Istituto Nazionale dei Tumori
B.5.2	Functional name of contact point	S.C. Anestesia e Rianimazione
B.5.3	Address:
B.5.3.1	Street Address	Via Venezian, 1
B.5.3.2	Town/ city	Milan
B.5.3.3	Post code	20133
B.5.3.4	Country	Italy
B.5.4	Telephone number	+390223902282
B.5.5	Fax number	+390223903366
B.5.6	E-mail	federico.piccioni@istitutotumori.mi.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	Bridion
D.2.1.1.2	Name of the Marketing Authorisation holder	Merck Sharp & Dohme Limited
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	Sugammadex
D.3.2	Product code	S
D.3.4	Pharmaceutical form	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.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	Yes
D.2.1.1.1	Trade name	Intrastigmina
D.2.1.1.2	Name of the Marketing Authorisation holder	Istituto Luso Farmaco d'Italia 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	Neostigmine
D.3.2	Product code	N
D.3.4	Pharmaceutical form	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

Neuromuscular block is commonly adopted during general anesthesia to facilitate tracheal intubation, mechanical ventilation and surgical manipulation. At the end of anesthesia it very important to avoid residual neuromuscular block to ensure adequate respiratory function preventing postoperative pulmonary complications. This trial compares the neuromuscular block reversal with different drugs (sugammadex vs neostigmine) after thoracic anesthesia.

Il blocco neuromuscolare è adottato in corso di anestesia generale per facilitare l'intubazione tracheale, la ventilazione meccanica e la manipolazione chirurgica. Al termine dell'anestesia è importante evitare la paralisi muscolare residua per garantire un'adeguata funzione respiratoria al paziente e ridurre il rischio di complicanze respiratorie postoperatorie. Lo studio confronta due antagonisti per il blocco neuromuscolare da rocuronio (sugammadex vs neostigmina) dopo anestesia toracica.

E.1.1.1

Medical condition in easily understood language

This study compares the efficacy of two drugs (sugammadex vs neostigmine) as reversal of muscular paralysis due to neuromuscular blocking agents administered during thoracic anesthesia.

Lo studio compara due farmaci (sugammadex vs neostigmina) nell'antagonizzare la paralisi muscolare indotta da farmaci paralizzanti durante anestesia toracica.

E.1.1.2

Therapeutic area

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

MedDRA Classification

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

The trial main objective is to demonstrate that sugammadex is faster than neostigmine to reach a TOF-ratio of 0.9 after thoracic anesthesia.
TOF-ratio is defined as the ratio of the fourth muscular twitch/first twitch value during an accelerometric train-of-four stimulation.

Dimostrare che sugammadex è più rapido della neostigmina nel favorire il raggiungimento di un TOF-ratio di 0.9 dopo anestesia toracica. Il TOF-ratio è definito come il rapporto tra l'intensità della quarta contrazione muscolare e la prima contrazione durante un treno di quattro stimoli mediante monitoraggio neuromuscolare accelerometrico.

E.2.2

Secondary objectives of the trial

Demonstrate that sugammadex allows a faster extubation.
Verify if there is a difference between sugammadex and neostigmine as regards adverse events after extubation and in the postoperative period (until the 30th day after surgery).

Dimostrare che sugammadex abbrevia il tempo necessario per l'estubazione dei pazienti.
Verificare se vi sia una differenza tra sugammadex e neostigmina in termini di incidenza di eventi avversi dopo l'estubazione e fino al 30mo giorno dopo l'intervento.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

- Subjects scheduled for pulmonary resection, lebectomy, pneumonectomy, bullectomy, pleurodesis
- Age 18-70 years
- ASA class 1,2,3
- Body Mass Index (BMI) 18-30 kg/m2

- Pazienti sottoposti a resezione polmonare, lobectomia, pneumonectomia, bullectomia, pleurodesi
- Età 18-70 anni
- Classe ASA 1,2,3
- Body Mass Index (BMI) 18-30 kg/m2

E.4

Principal exclusion criteria

- Subject scheduled for esofagectomy, thoracectomy, vascular resection
- COPD Gold class III and IV, respiratory infection, asthma
- Preoperative FEV1 < 60% of predicted, FEV1/FVC<70%
- Preoperative DLCO2/VA<60% of predicted
- Preoperative SpO2<92%, PaO2/FiO2<300
- Cardiovascular desease with a METS score less than 4
- Neuromuscular disorder
- Kidney insufficiency (eGFR<30 ml/min/1,73m2)
- Pregnant women

- pazienti sottoposti a esofagectomia, toracectomia, resezioni vascolari
- BPCO Gold class III and IV, infezioni respiratorie, asma bronchiale
- FEV1 preoperatorio < 60% del teorico, FEV1/FVC<70%
- DLCO2/VA preoperatorio < 60% del teorico
- SpO2 preoperatorio <92%, PaO2/FiO2<300
- Patologie cardiovascolari con METS score < 4
- Patologie neuromuscolari
- Insufficienza renale (eGFR<30 ml/min/1,73m2)
- Donne in stato di gravidanza

E.5 End points

E.5.1

Primary end point(s)

Time from reversal administration to TOF-ratio = 0.9

Tempo dalla somministrazione del farmaco decurarizzante al raggiungimento di un TOF-ratio=0.9

E.5.1.1

Timepoint(s) of evaluation of this end point

At the end of general anesthesia

A fine anestesia

E.5.2

Secondary end point(s)

Time from reversal administration to TOF-ratio = 1.0
Time from reversal administration to extubation
Adverse events and side effects incidence after extubation and in the postoperative period (until the 30th day after surgery)

Tempo dalla somministrazione del farmaco decurarizzante al raggiungimento di un TOF-ratio=1.0
Tempo dalla somministrazione del farmaco decurarizzante all'estubazione
Incidenza di eventi avversi ed effetti collaterali dopo l'estubazione e fino a 30 giorni dopo l'intervento chirurgico

E.5.2.1

Timepoint(s) of evaluation of this end point

At the end of general anesthesia (time to extubation)
Adverse events and side effects will be evaluated in the first 60 minutes after extubation, in the first 5 days after operation and at 30 days after surgery.

Alla fine dell'anestesia (tempo per l'estubazione).
Gli eventi avversi e gli effetti collaterali saranno valutati nella prima ora dopo l'estubazione, nei primi 5 giorni dopo l'intervento e a 30 giorni dalla chirurgia.

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

E.8.1.3

Single blind

E.8.1.4

Double blind

Yes

E.8.1.5

Parallel group

Yes

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

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

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

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

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:

200

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

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 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 2014-07-14.

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

266

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)

None

Nessuno

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

2014-09-04

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2014-09-23

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2024-12-15

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