Clinical Trials Register

Summary
EudraCT Number:	2013-002362-39
Sponsor's Protocol Code Number:	TALVISUG01
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:	2013-07-12
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

Spain - AEMPS

A.2

EudraCT number

2013-002362-39

A.3

Full title of the trial

Reducing the dose of sugammadex 50% reverse the neuromuscular blockade of rocuronium effectively after general anesthesia.

Reducir la dosis de sugammadex un 50% revierte el bloqueo neuromuscular de rocuronio de forma efectiva tras anestesia general.

A.3.1

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

Reversal of rocuronium with sugammadex at low doses

Reversion de rocuronio con sugammadex a bajas dosis

A.3.2

Name or abbreviated title of the trial where available

SUG01

A.4.1

Sponsor's protocol code number

TALVISUG01

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	Consorci Mar Parc de Parc de Salut de Barcelona (Parc de Salut MAR)
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	None
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	Hospital del Mar, Servicio de Anestesiología, Reanimación y Terapia del Dolor
B.5.2	Functional name of contact point	Fernando Escolano
B.5.3	Address:
B.5.3.1	Street Address	Passeig marítim, 25-29
B.5.3.2	Town/ city	Barcelona
B.5.3.3	Post code	08003
B.5.3.4	Country	Spain
B.5.4	Telephone number	0034932483250
B.5.5	Fax number	0034932483617
B.5.6	E-mail	FEscolano@parcdesalutmar.cat

D. IMP Identification
D.IMP: 1
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	Bridion Sugammadex EMEA/H/C/000885
D.2.1.1.2	Name of the Marketing Authorisation holder	N.V. Organon
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.3.1	Product name	Bridion
D.3.2	Product code	08466001
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
D.3.9.1	CAS number	343306-79-6
D.3.9.3	Other descriptive name	SUGAMMADEX
D.3.9.4	EV Substance Code	SUB26695
D.3.10	Strength
D.3.10.1	Concentration unit	mg/kg milligram(s)/kilogram
D.3.10.2	Concentration type	range
D.3.10.3	Concentration number	1 to 4
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	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 Sugammadex EMEA/H/C/000885
D.2.1.1.2	Name of the Marketing Authorisation holder	N.V. Organon
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.3.1	Product name	Bridion
D.3.2	Product code	08466001
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
D.3.9.1	CAS number	343306-79-6
D.3.9.3	Other descriptive name	SUGAMMADEX
D.3.9.4	EV Substance Code	SUB26695
D.3.10	Strength
D.3.10.1	Concentration unit	mg/kg milligram(s)/kilogram
D.3.10.2	Concentration type	range
D.3.10.3	Concentration number	2 to 8
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 is induced during general anesthesia, which often does not recover spontaneously, so it is necessary a pharmacological reversal. We believe that sugammadex at lower doses than those recommended by the technical datashet is useful for antagonizing rocuronium neuromuscular blockade during general anesthesia, although this effect is expected to be slower.

Durante una anestesia general se induce un bloqueo neuromuscular, que en muchas ocasiones no se recupera espontáneamente, por lo que es necesario su reversión farmacológica. Creemos que sugammadex con dosis inferiores a las recomendadas por el fabricante en la ficha técnica es igualmente útil para antagonizar el bloqueo neuromuscular por rocuronio durante una anestesia general, aunque este efecto será más lento.

E.1.1.1

Medical condition in easily understood language

Sugammadex antagonizing neuromuscular block by rocuronium in general anesthesia.

Antagonización de sugammadex del bloqueo neuromuscular por rocuronio de la anestesia general.

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	14.1
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.1.2 Medical condition or disease under investigation

E.1.2	Version	14.1
E.1.2	Level	PT
E.1.2	Classification code	10029315
E.1.2	Term	Neuromuscular blockade
E.1.2	System Organ Class	10029205 - Nervous system disorders

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

Study of lower doses versus standard doses equivalence in the reversal of neuromuscular blockade induced by rocuronium bromide. The dose recommended by the data sheet of sugammadex can be reduced up to 50% without losing efficacy in the reversal of neuromuscular blockade induced by rocuronium bromide in general anesthesia.

Estudio de equivalencia de dosis bajas frente a dosis habituales en la reversión del bloqueo neuromuscular inducido por bromuro de rocuronio. La reducción de la dosis recomendada por la ficha técnica de sugammadex puede reducirse hasta el 50% sin perder eficacia en la reversión del bloqueo neuromuscular inducido por bromuro de rocuronio en una anestesia general.

E.2.2

Secondary objectives of the trial

1.Establish decreasing sugammadex cost by reducing 50% of the recommended dose. One vial of sugammadex costs 70 euros, it requires 1-5 vials to reverse neuromuscular blockade of rocuronium bromide, depending on the depth. Is expected to decrease the economic cost of sugammadex 50%.
2.Check that although the time required to reverse the neuromuscular blockade of rocuronium bromide with sugammadex will be higher by reducing the dose recommended by the data sheet by 50%, this increase will not be clinically relevant.

1. Establecer la disminución de costo de sugammadex con la reducción del 50% de la dosis recomendada. Un vial de sugammadex cuesta 70 euros, se precisan de 1 a 5 viales para revertir un bloqueo neuromuscular de bromuro de rocuronio, en función de la profundidad del mismo. Se espera una reducción del costo económico de sugammadex del 50%.
2. Comprobar, que aunque el tiempo necesario para revertir el bloqueo neuromuscular de bromuro de rocuronio con sugammadex será mayor al reducir la dosis recomendada por la ficha técnica un 50%, este aumento no será clínicamente relevante.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Patients aged more than 18.
2. Patients with inform consent signed indicating that they have been informed of all pertinent aspects of the trial.
3. Patients scheduled for laparoscopic cholecystectomy Intervention.
4. Negative pregnancy test in the two weeks before the start of treatment (serum) in all women of childbearing age. Postmenopausal women have amenorrhea for at least 12 months to consider that are not of childbearing age.

1. Pacientes mayores de 18 años.
2. Pacientes que firmen el consentimiento informado indicando que han sido informados de todos los aspectos pertinentes sobre el ensayo.
3. Pacientes con Intervención programada de colecistectomia laparoscópica.
4. Prueba de embarazo negativa en las dos semanas previas del inicio del tratamiento (suero) en todas las mujeres en edad fértil. Las mujeres posmenopáusicas deben presentar amenorrea desde hace al menos 12 meses para considerar que no están en edad fértil.

E.4

Principal exclusion criteria

1. Patients who have refused to sign the consent form.
2. Patients with presence of an underlying neuromuscular disease.
3. Patients in whom the use of drugs known to interfere with neuromuscular transmission (anticonvulsants or aminoglycosides).
4. Patients with evidence or medical or surgical history relevant for the study.
5. Patients with severe-moderate renal insufficiency (creatinine clearance > or equal to 30 to <80 ml/ min or serum creatinine more than 1.8 mg / dl).
6. Liver disease (liver function tests with more than 50% above normal values).
7. History of difficult intubation, difficult intubation rates (Mallampatti> 3 thyromental Distance less than 7 and buccal overture <7 cm), which may be advised to use another anesthetic technique.
8. Patients with hypersensitivity to the active substance or to any of the excipients as indicated sugammadex data sheet.
9. Pregnant People who do not use contraceptives and effective means lactating women.

1. Pacientes que se nieguen a firmar el consentimiento informado.
2. Pacientes con presencia de una enfermedad neuromuscular subyacente.
3. Pacientes en los cuales el uso de fármacos conocidos interfieren en la transmisión neuromuscular (anticomiciales o aminoglucósidos).
4. Pacientes con evidencia o antecedentes médicos o quirúrgicos relevantes para el estudio.
5. Pacientes con Insuficiencia renal severa- moderada (aclaramiento de creatinina > o igual a 30 y < 80 ml/min o creatinina sérica de más de 1,8 mg/ dl).
6. Enfermedad hepática (pruebas de función hepática con más del 50% por encima de los valores normales).
7. Antecedentes de intubación traqueal difícil, índices de intubación orotraqueal difícil (Mallampatti >3, Distancia tiromentoniana menor a 7 y obertura bucal < 7 cm), que podría aconsejar usar otra técnica anestésica.
8. Pacientes con hipersensibilidad al principio activo o a alguno de los excipientes tal como indica la ficha técnica del sugammadex.
9. Personas embarazadas que no utilicen medios eficaces anticonceptivos y mujeres en periodo de lactancia.

E.5 End points

E.5.1

Primary end point(s)

Percentage of patients who are antagonized neuromuscular blockade with half dose recommended by the technical datasheet of sugammadex.

Porcentaje de pacientes en los que se antagoniza el bloqueo neuromuscular con la mitad de dosis aconsejada por la ficha técnica.

E.5.1.1

Timepoint(s) of evaluation of this end point

The time required to determine the effectiveness of half the dose recommended by the data sheet of sugammadex is produced in the same operating room.

El tiempo necesario para determinar la eficacia de la mitad de la dosis recomendada por la ficha técnica de sugammadex se produce en el mismo quirófano.

E.5.2

Secondary end point(s)

Increasing the time to reach a TOF ratio of 0.9 with half the dose recommended by the manufacturer. Financial savings this AmB.

Aumento del tiempo necesario para alcanzar un TOF-ratio 0.9 con la mitad de la dosis aconsejada por el fabricante. Ahorro económico que supone esta estategia.

E.5.2.1

Timepoint(s) of evaluation of this end point

The time required to determine if half of the dose recommended by the manufacturer time increases but recovery of neuromuscular blockade reduces costs is obtained at the end of the study.

El tiempo necesario para determinar si la mitad de la dosis recomendada por el fabricante aumenta el tiempo de recuperación del bloqueo neuromuscular pero disminuye los costos se obtendrá al final del estudio.

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

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

E.6.9

Dose response

Yes

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

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

Yes

E.8.2.3.1

Comparator description

La mitad de dosis del mismo producto

Half dose of same product

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

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

All necessary information will be obtained the knife, successive visits are not needed.

Todos los datos necesarios se obtendrán el quirófano, no se necesitan visitas sucesivas.

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

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

Yes

F.3 Group of trial subjects

F.3.1

Healthy volunteers

F.3.2

Patients

Yes

F.3.3

Specific vulnerable populations

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

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

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

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

2013-11-21

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2013-05-30

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

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