Clinical Trials Register

Summary
EudraCT Number:	2011-000401-50
Sponsor's Protocol Code Number:	CT-PED-2010-01
National Competent Authority:	Spain - AEMPS
Clinical Trial Type:	EEA CTA
Trial Status:	Ongoing
Date on which this record was first entered in the EudraCT database:	2011-09-15
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

Spain - AEMPS

A.2

EudraCT number

2011-000401-50

A.3

Full title of the trial

Efficacy and safety of reversal with Sugammadex (BRIDION®) from deep Neuromuscular Blockade induced by rocuronium in children

Eficacia y seguridad de la reversión con Sugammadex (BRIDION®) del bloqueo neuromuscular profundo inducido por Rocuronio en pediatría

A.3.1

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

Efficacy and safety of reversal with Sugammadex (BRIDION®) from deep Neuromuscular Blockade induced by rocuronium in children

A.3.2

Name or abbreviated title of the trial where available

SUGAPED 1

A.4.1

Sponsor's protocol code number

CT-PED-2010-01

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	Fundación para la Formación e Investigación Sanitarias de la Región de Murcia
B.1.3.4	Country	Spain
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	Fundación para la Formación e Investigación Sanitarias de la Región de Murcia
B.4.2	Country	Spain
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Fundación para la Formación e Investigación Sanitarias dela Región de Murcia
B.5.2	Functional name of contact point	Clinical Trials Information
B.5.3	Address:
B.5.3.1	Street Address	Hospital U. Virgen de la Arrixaca, Edificio AECC, 1ª Planta, Crtra. Madrid-Cartagena,sn
B.5.3.2	Town/ city	El Palmar
B.5.3.3	Post code	30820
B.5.3.4	Country	Spain
B.5.4	Telephone number	34968381290
B.5.5	Fax number	34968359777
B.5.6	E-mail	isabel.vasallo@carm.es

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 100 mg/ml solución inyectable
D.2.1.1.2	Name of the Marketing Authorisation holder	ORGANON, N.V.
D.2.1.2	Country which granted the Marketing Authorisation	Spain
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.3.4	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.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	SUGAMMADEX SODIO
D.3.9.3	Other descriptive name	SUGAMMADEX SODIO
D.3.10	Strength
D.3.10.1	Concentration unit	mg/ml milligram(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	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	Neostigmina Braun
D.2.1.1.2	Name of the Marketing Authorisation holder	Braun
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.3.4	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.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	NEOSTIGMINA
D.3.9.1	CAS number	59-99-4
D.3.9.3	Other descriptive name	NEOSTIGMINE
D.3.10	Strength
D.3.10.1	Concentration unit	mg/ml milligram(s)/millilitre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	0.5
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: 3
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	Atropina Sulfato Serra Pamies
D.2.1.1.2	Name of the Marketing Authorisation holder	Laboratorios Serra Pamies S.A.
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	Atropina
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.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	ATROPINA
D.3.9.1	CAS number	51-55-8
D.3.9.3	Other descriptive name	ATROPINE
D.3.10	Strength
D.3.10.1	Concentration unit	mg/ml milligram(s)/millilitre
D.3.10.2	Concentration type	up to
D.3.10.3	Concentration number	1
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 Blockade induced by Rocuronium

Bloqueo neuromuscular profundo inducido por Rocuronio

E.1.1.1

Medical condition in easily understood language

Neuromuscular Blockade induced by Rocuronium

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	14.0
E.1.2	Level	PT
E.1.2	Classification code	10057286
E.1.2	Term	Neuromuscular blockade reversal
E.1.2	System Organ Class	10042613 - Surgical and medical procedures

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 compare the efficacy and safety of the reversal with Sugammadex from deep neuromuscular blockade induced and maintained with rocuronium in pediatric patients scheduled for elective surgery and short duration and the reversal with neostigmine.

Comparar la eficacia y seguridad de la reversión con Sugammadex del bloqueo profundo (sin respuesta a TOF ratio y PTC< 2) inducido y mantenido con Rocuronio en pacientes pediátricos, programados para cirugía electiva e corta duración comparándolo con la técnica de reversión con Neostigmina.

E.2.2

Secondary objectives of the trial

To compare the residual relaxation over neostigmine.
-Compare the neostigmine-induced electrocardiographic changes regarding the possible occurrence of the same with sugammadex.
-Assess vital signs (respiratory rate, blood pressure, heart rate, body temperature, body weight, body mass index, etc.)..
-Compare the length of stay in intensive care with two blocking regimens.
-To compare the immediate postoperative morbidity.
-Assess the number of withdrawal of patients in both groups (dropout).
-Record the necessary concomitant.

Comparar la relajación residual respecto a Neostigmina.
-Comparar las alteraciones electrocardiográficas inducidas por Neostigmina respecto a la posible aparición de las mismas con Sugammadex.
-Valorar las constantes vitales (Frecuencia respiratoria, presión arterial, frecuencia cardiacas, temperatura corporal , peso corporal, Indice de masa corporal, etc.).
-Comparar el tiempo de estancia en reanimación con los dos regímenes de tratamiento bloqueante.
-Comparar la morbilidad postoperatoria inmediata.
-Valorar el número de retirada de pacientes en ambos grupos (tasa de abandono).
-Registrar los tratamientos concomitantes necesarios.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

Children of both sexes, aged between two and eleven years will have surgery for procedures of short duration (less than one hour) and requiring muscle relaxation.

Niños, de ambos sexos, en edades comprendidas entre dos y once años que vayan a ser intervenidos quirúrgicamente para procedimientos de corta duración (menos de una hora) y que precisen relajación muscular.

E.4

Principal exclusion criteria

-Express their wish not to participate in the trial
- Patients with anticipated difficult airway
- Patients with Neuromuscular disease-present
-Liver failure and / or renal
-Have personal or family history of malignant hyperthermia,
-Submitted previous allergic reaction to any anesthetic.
-On treatment at the time of the study with aminoglycosides, magnesium, anticonvulsants, toremifene, Flucloxacillin and Fusidic Acid

-Manifiesten su deseo de no participar en el ensayo
- presenten vía aérea difícil anticipada
-presenten enfermedad neuromuscular
-presenten insuficiencia hepática y/o renal,
-tengan antecedentes personales o familiares de hipertermia maligna,
-hayan presentado reacción alérgica previa a cualquier anestésico.
-estén en tratamiento en el momento de realizar el estudio con Aminoglucósidos, Magnesio, Anticonvulsivantes, Toremifeno, Flucloxacilina y Ácido Fusídico

E.5 End points

E.5.1

Primary end point(s)

Efficacy Variable: The time in seconds elapsed since the administered dose of 4 mg / kg sugammadex or neostigmine and atropine (0.05 mg.kg and 0.025 mg/kg )until you get a T4/T1 ratio> 0.9 (Both groups).
Safety variable:Profile of adeverse events in both groups

Variable de Eficacia: El tiempo, en segundos, trascurrido desde que se administra la dosis de 4 mg/kg de Sugammadex o de neostigmina 0.05 mg.kg y atropina 0.025 mg/kg, hasta que se consigue un ratio T4/T1 > 0.9 (ambos grupos).
Variable de seguridad: registro de acontecimientos adversos

E.5.1.1

Timepoint(s) of evaluation of this end point

At the end of the surgery

E.5.2

Secondary end point(s)

Clinical and hemodynamic intra-operative and post-operative monitoring (15, 30, 45, 50 and 60 min after reversal drug)
- Rhythm and Heart Rate (beats / min), ECG.
-Systolic blood pressure (mm Hg)
- Diastolic blood pressure (mm Hg)
- Arterial oxygen saturation (%)
- Total dose of rocuronium.

• Monitoring of neuromuscular function (TOF-Watch)
-Time, in seconds, from the initial dose administered of rocuronium until the maximum block is achieved (Onset time)
-The time in seconds which elapses after the administration of 4 mg / kg dose of sugammadex or neostigmine 0.05 mg.kg and atropine 0.025 mg.kg until a T4/T1 > 0.8.ratio is achieved
-The time in seconds which elapses from the administered dose of 4 mg / kg of sugammadex or neostigmine 0.05 mg.kg and atropine 0.025 mg.kg until a T4/T1 > 0.7. ratio is achieved
- T2 Recovery time after Sugammadex
- Comeback time T3 after Sugammadex
- Comeback time T4 after Sugammadex
- Time to extubation after Sugammadex

Clinical course:
1. Subjective level of consciousness:
A. Awake and oriented
B. Waking up with minimal stimulation.
C. Responds only to tactile stimulation.
2. Can cooperate? No / Yes
3. Can keep the head up for 5 seconds? No / Yes
4. Muscle weakness? No / Yes
5. Length of stay in Recovery Unit

E.5.2.1

Timepoint(s) of evaluation of this end point

After experimental treatment

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

Yes

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)

Yes

E.7.4

Therapeutic use (Phase IV)

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

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

Yes

E.8.4

The trial involves multiple sites in the 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

Yes

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

The end of the trial coincides with the last visit of the last patient enrolled in the trial

El final del ensayo coincidirá con la última visita del último paciente incluido en el ensayo

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

Number of subjects for this age range:

100

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)

Yes

F.1.1.5.1

Number of subjects for this age range:

100

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

Paediatric population

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

100

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)

Treatment is not different from 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

2011-08-09

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2011-04-11

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

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