Clinical Trials Register

Summary
EudraCT Number:	2014-004725-40
Sponsor's Protocol Code Number:	ECOBT
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:	2015-09-11
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

2014-004725-40

A.3

Full title of the trial

Interfascial effectiveness of ultrasound-guided blocking in transurethral resection of bladder tumor

Eficacia del bloqueo obturador interfascial ecoguiado en la resección transuretral de tumor vesical

A.3.1

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

Obturator nerve anesthesia guided by ultrasound to facilitate complete resection of bladder tumor

Anestesia del nervio obturador guiado por ecografia para facilitar la resección completa del tumor vesical

A.4.1

Sponsor's protocol code number

ECOBT

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 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	No
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	Servicio de Urología y Trasplante Renal
B.5.2	Functional name of contact point	Servicio de Urología y Traspl. Rena
B.5.3	Address:
B.5.3.1	Street Address	Paseo Marítimo, 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	0034933160785
B.5.5	Fax number	0034932483433
B.5.6	E-mail	cllonch@imim.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	LIDOCAÍNA 2% INYECTABLE BRAUN MINIPLASCO
D.2.1.1.2	Name of the Marketing Authorisation holder	B. Braun Medical, S.A
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	Intramuscular use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Lidocaine
D.3.9.1	CAS number	137-58-6
D.3.9.2	Current sponsor code	LIDOCAINA
D.3.9.3	Other descriptive name	LIDOCAINE
D.3.9.4	EV Substance Code	SUB08507MIG
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	200
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
D.8 Placebo: 1
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Solution for injection
D.8.4	Route of administration of the placebo	Intramuscular use

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Bladder cancer

Tumor vesical

E.1.1.1

Medical condition in easily understood language

Bladder cancer

Tumor vesical

E.1.1.2

Therapeutic area

Diseases [C] - Cancer [C04]

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

Assess whether the blockade of the obturator nerve at the groin ultrasound-guided lidocaine 2%, reduces adductor muscle spasm risk compared to placebo use during transurethral resection of bladder tumor located in a side face (inferolateral portion).

Evaluar si el bloqueo del nervio obturador ecoguiado a nivel inguinal con lidocaína 2%, disminuye el riesgo de espasmo del músculo aductor en comparación con el uso de placebo durante la RTU de tumor vesical localizado en una cara lateral (porción ínfero-lateral).

E.2.2

Secondary objectives of the trial

Analyze possible differences in:
a) Risk of bladder perforations,
b) Quality of resection, based on the correct representation of muscular layer and
c) Time of resection between the two groups

Analizar posibles diferencias en:
a) el riesgo de perforaciones vesicales,
b) la calidad de resección, basada en la correcta representación de capa muscular y
c) el tiempo de resección entre los dos grupos

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Adult patients of both genre aged between 18 and 85 years, BMI less than 40.
2. Bladder tumor diagnosed by ultrasound and / or flexible cystoscopy candidate for surgery transurethral resection of bladder tumor side face within three months of diagnosis.
3. Single or multi-level lesion located anterior quadrant of the side faces bladder.
4. Clinical indication for transurethral resection (TUR) of bladder tumor.
5. Patients who signed informed consent indicating that they have been informed of all pertinent aspects of the trial.

1.-Pacientes adultos de ambos sexos de edades comprendidas entre los 18 y 85 años, IMC menor de 40.
2.-Tumor vesical diagnosticado por ecografía y/o cistoscopia flexible candidato a cirugía de resección transuretral de tumor de vejiga en cara lateral antes de tres meses del diagnóstico.
3.-Lesión única o múltiple localizada a nivel del cuadrante anteroinferior de una de las caras vesicales laterales.
4.-Indicación clínica para realizar una resección transuretral (RTU) de tumor vesical.
5.-Pacientes que firmen el consentimiento informado indicando que han sido informados de todos los aspectos pertinentes sobre el ensayo.

E.4

Principal exclusion criteria

1. Physical State assessed by ASA> 4 and / or ECOG> 4
2. Allergy or hypersensitivity to lidocaine or any of the excipients of the study drug.
3. Pregnant or breast-feeding.
4. Participation in a clinical drug research before 3 months in pre-drug administration.
5. Concomitant use of the following drugs: amiodarone, disopyramide, phenobarbital, phenytoin, monoaminooxidas inhibitors.
6. Subjects with contraindications for regional anesthesia: patient refusal, skin infection, severe neurology pathology, severe thrombocytopenia (platelet count <100,000) receiving both treatment groups.

1. Estado físico con valoración ASA>4 y/o ECOG>4 (Ver anexos IV y V).
2. Alergia o hipersensibilidad a la lidocaína o a alguno de los excipientes del medicamento en estudio.
3. Mujeres embarazadas o en periodo de lactancia.
4. Participación en alguna investigación clínica con medicamentos dentro de los 3 meses anteriores a la administración del fármaco.
5. Uso concomitante de los siguientes medicamentos: amiodarona, disopiramida, fenobarbital, fenitoína, inhibidores de la monoaminooxidas.
6. Sujetos con contraindicaciones para recibir anestesia regional: negativa del paciente, infección cutánea, patología neurologia grave, trombopenia severa (número de plaquetas <100.000) que reciben ambos grupos de tratamiento.

E.5 End points

E.5.1

Primary end point(s)

Presence (or absence) of adductor muscle contraction during transurethral resection.

Presencia (o ausencia) de contracción del músculo aductor durante la resección transuretral.

E.5.1.1

Timepoint(s) of evaluation of this end point

During transurethral resection (it will finish in a maximum of 2 hours)

Durante la resección transuretral (terminará en un máximo de 2 horas)

E.5.2

Secondary end point(s)

- Presence of uncontrolled bladder perforation at the end resection.
-Quality Resection determined by the correct representation of muscle layer at the discretion of the study pathologist (presence or absence of the muscular layer)
-Time Resection.

-Presencia de perforación vesical incontrolada al concluir resección.
-Calidad de la resección, determinada por la correcta representación de capa muscular a criterio del patólogo del estudio (presencia o ausencia de la capa muscular)
-Tiempo de resección.

E.5.2.1

Timepoint(s) of evaluation of this end point

Maximum of 6 hours

Un máximo de 6 horas

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

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)

E.8.2.2

Placebo

Yes

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

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

Last visit of the last recruited patient.

Última visita del último paciente reclutado.

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)

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

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)

Patients will receive adequate treatment by their physician.

Los pacientes recibirán el tratamiento que su médico considere oportuno.

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

2015-11-04

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2015-06-19

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

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