Clinical Trials Register

Summary
EudraCT Number:	2009-012963-33
Sponsor's Protocol Code Number:	CORTEEC
National Competent Authority:	Spain - AEMPS
Clinical Trial Type:	EEA CTA
Trial Status:	Restarted
Date on which this record was first entered in the EudraCT database:	2010-09-16
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

Expand All Collapse All

A. Protocol Information

A.1

Member State Concerned

Spain - AEMPS

A.2

EudraCT number

2009-012963-33

A.3

Full title of the trial

ENSAYO CLINICO FASE II CORTICOIDES PARA EL EMPIEMA Y EL DERRAME PLEURAL PARANEUMÓNICO EN NIÑOS

MULTICENTRIC, PHASE II, CLINICAL TRIAL CORTICOIDS FOR EMPYEMA AND PLEURAL EFFUSION IN CHILDREN

A.3.2

Name or abbreviated title of the trial where available

CORTEEC

A.4.1

Sponsor's protocol code number

CORTEEC

A.7

Trial is part of a Paediatric Investigation Plan

Information not present in EudraCT

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	ALFREDO TAGARRO GARCIA
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
B.4.2	Country
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation
B.5.2	Functional name of contact point

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	DEXAMETASONA KERN PHARMA 4 mg/ml Solución Inyectable
D.2.1.1.2	Name of the Marketing Authorisation holder	KERN PHARMA, S.L.
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	Information not present in EudraCT
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	DEXAMETASONA FOSFATO SODIO
D.3.9.3	Other descriptive name	DEXAMETHASONE SODIUM PHOSPHATE
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	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)	Information not present in EudraCT
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	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	Information not present in EudraCT
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	Information not present in EudraCT
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	Information not present in EudraCT
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	CEFOTAXIMA
D.3.2	Product code	CEFOTAXIMA
D.3.4	Pharmaceutical form	Powder for injection*
D.3.4.1	Specific paediatric formulation	Information not present in EudraCT
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	CEFOTAXIMA
D.3.9.1	CAS number	63527-52-6
D.3.9.3	Other descriptive name	CEFOTAXIME
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	range
D.3.10.3	Concentration number	250 to 1000
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	CEFOTAXIMA
D.3.9.1	CAS number	63527-52-6
D.3.9.3	Other descriptive name	CEFOTAXIME
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	range
D.3.10.3	Concentration number	250 to 1000
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)	Information not present in EudraCT
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	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	Information not present in EudraCT
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	Information not present in EudraCT
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	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	Information not present in EudraCT
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	RANITIDINA
D.3.2	Product code	RANITIDINA
D.3.4	Pharmaceutical form	Suspension for injection
D.3.4.1	Specific paediatric formulation	Information not present in EudraCT
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	RANITIDINA
D.3.9.1	CAS number	66357-35-5
D.3.9.3	Other descriptive name	RANITIDINE
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	10
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)	Information not present in EudraCT
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	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	Information not present in EudraCT
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	Information not present in EudraCT
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	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	AUGMENTINE 100/12,5mg, polvo para suspensión oral
D.2.1.1.2	Name of the Marketing Authorisation holder	GLAXOSMITHKLINE, 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	Powder for oral suspension
D.3.4.1	Specific paediatric formulation	Information not present in EudraCT
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	CLAVULANATO POTASIO
D.3.9.1	CAS number	61177-45-5
D.3.9.3	Other descriptive name	CLAVULANATE POTASSIUM
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	12.5
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	AMOXICILINA TRIHIDRATO
D.3.9.1	CAS number	61336-70-7
D.3.9.3	Other descriptive name	AMOXICILLIN TRIHYDRATE
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)	Information not present in EudraCT
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	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	Information not present in EudraCT
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	Information not present in EudraCT
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	Intravenous use

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

DERRAME PLEURAL PARANEUMONICO
(PARAPNEUMONIC PLEURAL EFFUSSION)

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	11
E.1.2	Level	LLT
E.1.2	Classification code	10032736
E.1.2	Term	Otras formas especificadas de derrame pleural, excepto el tuberculoso

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

1. Investigar si asociar dexametasona 0.25 mg/kg/6 h durante 2 días al tratamiento antibiótico habitual disminuye el tiempo hasta curación del derrame pleural paraneumónico (DPP).

E.2.2

Secondary objectives of the trial

2.1 Evaluar el efecto de añadir dexametasona 0.25 mg/kg/6 h durante 2 días al tratamiento antibiótico habitual sobre la aparición de complicaciones durante el episodio de DPP, considerando como complicaciones:
- Presencia de pioneumotórax, absceso pulmonar o paquipleuritis.
- Secuelas pulmonares
- Fallecimiento.
- Necesidad de cirugía (en el subgrupo que inicialmente sólo precisa tratamiento médico), considerando como “tratamiento médico” los fármacos y la toracocentesis evacuadora y considerando como “tratamiento quirúrgico” la inserción de tubo de tórax y la toracoscopia.

2.2 Evaluar la incidencia de acontecimientos adversos graves y no graves asociados con el nuevo tratamiento en comparación con el tratamiento estándar.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

• Paciente mayor de 1 mes de edad y menor de 14 años.
• Presencia de neumonía (diagnosticada mediante criterios clínicos y radiológicos: tos, fiebre y consolidación radiológica)
• Evidencia radiológica (radiografía y ecografía) de derrame pleural (se incluyen derrames de cualquier cuantía).
• Paciente que otorgue el consentimiento informado para participar en el estudio.

E.4

Principal exclusion criteria

1. Paciente que presente alergia comprobada a cualquiera de los fármacos del estudio: dexametasona, cefotaxima, ranitidina y Amoxicilina-Clavulánico.
2. Paciente con inmunodeficiencia celular o humoral congénita o adquirida.
3. Enfermedad concomitante susceptible de empeorar con el tratamiento corticoideo.
4. Paciente que, a criterio del investigador, presente cualquier condición médica general o psicológica que le impida participar en el estudio.

E.5 End points

E.5.1

Primary end point(s)

Variable principal:
- Tiempo hasta curación.
o Considerando “curación” los siguientes criterios:
 Neumonía en resolución.
 >24 horas sin necesidad de oxígeno.
 >48 horas afebril.
 Ausencia de distrés respiratorio.
 Derrame pleural en resolución (el médico encargado considera que no deben realizarse más técnicas intervencionistas).
 Buena tolerancia oral a alimentos.
Considerando “tiempo hasta”:
Se contabilizará “Primer día” A EFECTOS DEL ESTUDIO aquel en que el paciente reciba su primera dosis de dexametasona/placebo intravenoso (independientemente de que esto suceda el día del ingreso o cuando lleva varios días ingresado).
A efectos del estudio el día 1 es el día en que recibe su primera dosis de dexametasona (de 0 a 24 horas). Por definición, habrá transcurrido un máximo de 12h desde su diagnóstico.
Se contabilizará “Tiempo hasta curación” de la siguiente manera: si el día en que el paciente cumple todos los criterios de alta es el día 7 desde el diagnóstico, el tiempo hasta curación será: 7-1=6.
Ejemplo 1:
Diagnóstico: día 1 de octubre a las 23h.
Inicio de tratamiento: día 2 de octubre a las 10 h.=DIA 1.
Cumplimiento de criterios de curación: día 12 de octubre a las 13 h = DIA 11.
TIEMPO HASTA CURACIÓN: 11-1=10 DIAS.

Ejemplo 2:
Diagnóstico: día 14 de noviembre a las 13 horas.
Inicio de tratamiento: día 14 de noviembre a las 12 horas = DIA 1
Cumplimiento de criterios de curación: día 30 de noviembre a las 10 h = DIA 17
TIEMPO HASTA CURACIÓN: 17-1=16 DÍAS.

Variables secundarias:
a) De eficacia
- Número de niños con complicaciones. Como complicación se entiende:
o Complicaciones pulmonares: presencia de pioneumotórax, absceso pulmonar o paquipleuritis.
o Fallecimiento: fallecimiento secundario a la infección pulmonar o por otra causa.
o Secuelas: presencia de secuelas al mes del alta.
- En el subgrupo de estratificación “Tratamiento Médico”, es decir, los que al diagnóstico no cumplen criterios de necesitar cirugía: Número de niños que tienen que someterse a tratamiento quirúrgico, entendiendo como tal:
o Inserción de tubo de tórax.
o Videotoracoscopia, toracoscopia o decorticación.

b) De seguridad
a. Hiperglucemia (mg/dL en medición venosa o capilar) sin significación clínica: número esperable: 25-50%.
i. Leve: 126-140.
ii. Moderada: 140-200.
iii. Severa: >200
b. Hiperglucemia con significación clínica: necesidad de insulina por hiperglucemia severa persistente durante >48 h: número esperable: ninguno.
c. Signos sospechosos de hemorragia gastrointestinal: número esperable: 0-1.
i. Hemorragia digestiva alta:
1. Leve: sangre oculta en heces +.
2. Moderada: melenas o hematemesis sin repercusión hemodinámica, vómitos con restos hemáticos.
3. Severa: melenas o hematemesis con repercusión hemodinámica.
ii. Anemización:
1. Leve: < 1 gr/L de Hb entre la segunda analítica (el día 3 de estudio) y la primera analítica (al ingreso). Número esperable: 4
2. Moderada: < 2 gr/L de Hb entre la segunda analítica (el día 3 de estudio) y la primera analítica (al ingreso). Número esperable: 2
3. Severa: < 3 gr/L de Hb entre la segunda analítica (el día 3 de estudio) y la primera analítica (al ingreso). Número esperable: ninguno.
d. Necesidad de transfusión: número esperable: ninguno.
e. Candidiasis bucofaríngea: número esperable: 5-10.
f. Reacción alérgica: máximo 1.
g. Resto de reacciones adversas incluidas en ficha técnica. Número esperable: ninguno.

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

Information not present in EudraCT

E.7.1.2

Bioequivalence study

Information not present in EudraCT

E.7.1.3

Other

Information not present in EudraCT

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

Yes

E.7.3

Therapeutic confirmatory (Phase III)

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.8.3

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

Information not present in EudraCT

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

Se finalizará por protocolo cuando se hayan reclutado y estudiado a todos los pacientes.
Se finalizará de forma anticipada el estudio si se halla un aumento de acontecimientos adversos que haga sospechar que alguno de los grupos estudiados tiene una evolución peor de lo esperado con respecto al manejo estándar de la enfermedad.
Se finalizará también si se reclutan menos del 30% de los pacientes en el primer año, contando desde el primer reclutamiento.

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

Yes

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)

Yes

F.1.1.5

Children (2-11years)

Yes

F.1.1.6

Adolescents (12-17 years)

Yes

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

NIÑOS, MENORES NO MADUROS.

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

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

2010-10-04

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2010-05-06

P. End of Trial
P.	End of Trial Status	Restarted

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