Clinical Trials Register

Summary
EudraCT Number:	2014-001930-26
Sponsor's Protocol Code Number:	LEOC/FJD-14/01
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:	2014-08-14
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

Spain - AEMPS

A.2

EudraCT number

2014-001930-26

A.3

Full title of the trial

A randomized, evaluator blinded clinical trial to compare clinical efficacy of four different analgesic strategies in patients undergoing Extracorporeal Shock Wave Lithotripsy (ESWL).

Ensayo clínico aleatorizado, enmascarado para el evaluador, para evaluar la eficacia de cuatro pautas analgésicas en pacientes sometidos a litotricia extracorpórea con ondas de choque (LEOC).

A.3.1

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

Study to evaluate clinical efficacy of four different strategies to control pain in patients undergoing Lithotripsy

Estudio para evaluar la eficacia clínica de 4 estrategias para controlar el dolor en pacientes sometidos a Litotricia

A.4.1

Sponsor's protocol code number

LEOC/FJD-14/01

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	INSTITUTO DE INVESTIGACION SANITARIA FUNDACION JIMENEZ DIAZ
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	INSTITUTO DE INVESTIGACIÓN SANITARIA FUNDACION JIMENEZ DIAZ
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	INSTITUTO DE INVESTIGACION SANITARIA FUNDACION JIMENEZ DIAZ
B.5.2	Functional name of contact point	LUCIA LLANOS JIMÉNEZ
B.5.3	Address:
B.5.3.1	Street Address	AVDA REYES CATÓLICOS Nº2
B.5.3.2	Town/ city	MADRID
B.5.3.3	Post code	28040
B.5.3.4	Country	Spain
B.5.4	Telephone number	00349155048003144
B.5.6	E-mail	lucia.llanos@fjd.es

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	DORMICUM 5MG/5ML
D.2.1.1.2	Name of the Marketing Authorisation holder	ROCHE FARMA
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	MIDAZOLAM
D.3.9.1	CAS number	59467-70-8
D.3.9.4	EV Substance Code	SUB08950MIG
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	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.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	FENTANEST 0.05MG/ML
D.2.1.1.2	Name of the Marketing Authorisation holder	KERN PHARMA
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	FENTANYL
D.3.9.3	Other descriptive name	FENTANYL
D.3.9.4	EV Substance Code	SUB07597MIG
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	0.05
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	ENANTYUM 50 MG/2ML
D.2.1.1.2	Name of the Marketing Authorisation holder	LABORATORIOS MENARINI
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	DEXKETOPROFEN
D.3.9.1	CAS number	22161-81-5
D.3.9.4	EV Substance Code	SUB07034MIG
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	25
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: 4
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	KALINOX 170 bar
D.2.1.1.2	Name of the Marketing Authorisation holder	AIR LIQUIDE Santé INTERNATIONAL
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	Inhalation vapour
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Inhalation 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

Pain in Nephrolithiasis in whom Extracorporeal shock wave lithotripsy is indicated

Dolor en Litiasis renal con indicación de Litotricia extracorpórea por ondas de choque.

E.1.1.1

Medical condition in easily understood language

Mangement of pain in Renal stones where Lithotripsy is indicated

Manejo del dolor en Litiasis renal con indicación para litotricia

E.1.1.2

Therapeutic area

Diseases [C] - Symptoms and general pathology [C23]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	17.0
E.1.2	Level	HLT
E.1.2	Classification code	10017926
E.1.2	Term	Gastrointestinal and abdominal pains (excl oral and throat)
E.1.2	System Organ Class	100000004856

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 of four different analgesic strategies during ESWL procedure in patients with Nephrolithiasis.

Comparar la eficacia analgésica, en términos de intensidad de dolor, de 4 diferentes pautas analgésicas durante el procedimiento de LEOC en modo ambulatorio para pacientes con litiasis renal.

E.2.2

Secondary objectives of the trial

- To analize pain intensity improvement at different time points during the procedure.
- To analize the influence of the analgesic effect of the different strategies on ESWL outcome
- To study the influence of BMI, size and composition of the Stone in pain intensity

- Análisis de los cambios con el tiempo en la valoración subjetiva del dolor durante el procedimiento de Litotricia Extracorpórea por Ondas de Choque (LEOC) en modo ambulatorio.
- Análisis de la influencia de la pauta analgésica y antiálgica en la eficacia del tratamiento mediante LEOC de litiasis renales.
- Análisis en la influencia de variables como el IMC, el tamaño y la composición de la litiasis en la valoración subjetiva del dolor durante el procedimiento de Litotricia Extracorpórea por Ondas de Choque (LEOC) en modo ambulatorio.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

? Diagnosis of renal lithiasis located in pelvis or medium or superior calix, Pacientes diagnosticados de litiasis renal, en pelvis o cálices medios o superiores, for which ESWL is indicated.
? Age ? 18 years old.
? Subjects that give their written consent after receiving appropriate information about the aim, procedures, potential benefits and harms of the study, and that their participation is voluntary.

? Pacientes diagnosticados de litiasis renal, en pelvis o cálices medios o superiores, subsidiarios de tratamiento mediante LEOC.
? Edad ? a 18 años.
? Sujetos que tras haber recibido información sobre el diseño, los fines del proyecto, los posibles riesgos de que él puedan derivarse y de que en cualquier momento pueden denegar su colaboración, otorguen por escrito su consentimiento de participar en el estudio.

E.4

Principal exclusion criteria

? Subjects unable to understand the study procedures and/or to collaborate during its development.
? Not willing to give their written consent.
? ESWL contraindicated
? Having a double J catheter.
? Lithiasis bigger than 2cm
? Chronic opioid use
? Present treatment with antiplatelet of anticoagulant agents.
? Previous ESWL
? Contraindication to use of any of the study medications (dormicum, fentanest, enantyum of kalinox).

? Incapacidad para entender las instrucciones o colaborar durante el desarrollo del estudio y/o ausencia de consentimiento firmado.
? Negativa del paciente a firmar el Consentimiento Informado
? Contraindicación para el tratamiento mediante LEOC
? Pacientes portadores de catéter doble J
? Pacientes con litiasis mayor de 2cm
? Uso crónico de opioides indicados para otra patología
? Tratamiento activo con fármacos antiagregantes o anticoagulantes. En caso de que el paciente esté tomando AAS, se seguirá la práctica habitual de retirar una semana antes del procedimiento y reintroducir al día siguiente del mismo.
? Haber sido sometido a LEOCs previas
? Contar con alguna de las contraindicaciones para la aplicación de la medicación analgésica

E.5 End points

E.5.1

Primary end point(s)

To compare efficacy, in terms of pain intensity measured with VAS of 4 analgesic strategies in patients undergoing ESWL

Comparar la eficacia analgésica, en términos de intensidad de dolor, medida a través de una Escala Analógica Visual, de 4 pautas analgésicas durante el procedimiento de LEOC en modo ambulatorio para pacientes con litiasis renales.

E.5.1.1

Timepoint(s) of evaluation of this end point

At the end of the procedure

Al terminar el procedimiento

E.5.2

Secondary end point(s)

o To analyze changes in pain intensity during the procedure o To analyze the influence of the analgesic strategy on ESWL efficacy.
o To analyze the influence of BMI and stone size, location and composition in pain intensity during the procedure.
o To compare the need for rescue medication among the four analgesic strategies.
o To compare early complications rate after ESWL.
o To compare safety and tolerability among the four analgesic strategies.
o To compare the patient satisfaction with the procedure and the received analgesic strategy.

o Analizar los cambios con el tiempo en la intensidad de dolor durante el procedimiento de Litotricia Extracorpórea por Ondas de Choque (LEOC) en modo ambulatorio.
o Analizar la influencia de la pauta analgésica y antiálgica en la eficacia del tratamiento mediante LEOC de litiasis renales.
o Analizar la influencia de variables como el IMC, el tamaño y la composición de la litiasis en la intensidad del dolor durante el procedimiento Comparar la necesidad de uso de medicación de rescate entre los pacientes asignados a las diferentes pautas.
o Comparar la tasa de complicaciones precoces tras la LEOC.
o Comparar la proporción de pacientes que precisan medicación de rescate en cada grupo.
o Comparar la seguridad y tolerabilidad de las 4 pautas.
o Comparar el grado de satisfacción del paciente con las diferentes pautas analgésicas y la proporción de pacientes que aceptarían la misma pauta en procedimientos futuros.

E.5.2.1

Timepoint(s) of evaluation of this end point

At the end of the procedure

Al final del procedimiento

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)

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

E.8.1.5

Parallel group

Yes

E.8.1.6

Cross over

E.8.1.7

Other

Yes

E.8.1.7.1

Other trial design description

enmascarado para el evaluador

evaluator blinded

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

El grupo control es la pauta usada en la práctica clínica habitual en nuestro centro

The comparator is the strategy used in clinical practice in our centre

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

End of trial is defined as the last visit of the last patient.

El fin del estudio se define como la última visita del ultimo paciente

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:

120

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

120

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

120

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

NINGUNO

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

2014-10-10

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2014-07-30

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

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