Clinical Trials Register

Summary
EudraCT Number:	2011-002235-26
Sponsor's Protocol Code Number:	OTR3002
National Competent Authority:	Spain - AEMPS
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2011-09-07
Trial results	View 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

2011-002235-26

A.3

Full title of the trial

An Open-label, Extension Study to Assess the Long-Term Safety of Twice Daily Oxycodone Hydrochloride Controlled-release Tablets in Opioid Experienced Children Who Completed the OTR3001 Study

Estudio abierto de extensión para evaluar la seguridad a largo plazo de la administración dos veces al día de comprimidos de liberación controlada de clorhidrato de oxicodona en pacientes pediátricos ya expuestos a los opioides que hayan finalizado el estudio OTR3001

A.3.1

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

Study of the safety of the long-acting opioid pain medication Oxycodone hydrochloride in children who have been treated previously with opioid pain medication who completed the OTR3001 study

Estudio de la seguridad del tratamiento analgésico opioide con clorhidrato de oxicodona de larga duración en niños expuestos previamente a un tratamiento analgésico con opioides que han completado el estudio OTR3001

A.4.1

Sponsor's protocol code number

OTR3002

A.5.2

US NCT (ClinicalTrials.gov registry) number

NCT01369615

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	Purdue Pharma L.P.
B.1.3.4	Country	United States
B.3.1 and B.3.2	Status of the sponsor	Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	Purdue Pharma L.P.
B.4.2	Country	United States
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	PRA International
B.5.2	Functional name of contact point	Purdue Pediatric Call Centre
B.5.3	Address:
B.5.3.1	Street Address	Glen Lake 6, 4130 Parklake Avenue, Suite 400.
B.5.3.2	Town/ city	Raleigh, NC
B.5.3.3	Post code	27612
B.5.3.4	Country	United States
B.5.4	Telephone number	+1434951 4115
B.5.5	Fax number	+1913599 2753
B.5.6	E-mail	PurduePediatric@praintl.com

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	Comprimidos de liberación controlada de clorhidrato de oxicodona (Oxycontin®)
D.2.1.1.2	Name of the Marketing Authorisation holder	Purdue Pharma L.P.
D.2.1.2	Country which granted the Marketing Authorisation	United States
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	Comprimidos de liberación controlada de clorhidrato de oxicodona dos veces al día
D.3.2	Product code	Oxicodona HCl CR
D.3.4	Pharmaceutical form	Tablet
D.3.4.1	Specific paediatric formulation	No
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	Clorhidrato de oxicodona
D.3.9.2	Current sponsor code	OTR3002
D.3.9.3	Other descriptive name	N/A
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	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)	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	Comprimidos de liberación controlada de clorhidrato de oxicodona (Oxycontin®)
D.2.1.1.2	Name of the Marketing Authorisation holder	Purdue Pharma L.P.
D.2.1.2	Country which granted the Marketing Authorisation	United States
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	Comprimidos de liberación controlada de clorhidrato de oxicodona dos veces al día
D.3.2	Product code	Oxicodona HCl CR
D.3.4	Pharmaceutical form	Tablet
D.3.4.1	Specific paediatric formulation	No
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	clorhidrato de oxicodona
D.3.9.2	Current sponsor code	OTR3002
D.3.9.3	Other descriptive name	N/A
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	15
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	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	Comprimidos de liberación controlada de clorhidrato de oxicodona (Oxycontin®)
D.2.1.1.2	Name of the Marketing Authorisation holder	Purdue Pharma L.P.
D.2.1.2	Country which granted the Marketing Authorisation	United States
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	Comprimidos de liberación controlada de clorhidrato de oxicodona dos veces al día.
D.3.2	Product code	Oxicodona HCl CR
D.3.4	Pharmaceutical form	Tablet
D.3.4.1	Specific paediatric formulation	No
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	clorhidrato de oxicodona
D.3.9.2	Current sponsor code	OTR3002
D.3.9.3	Other descriptive name	N/A
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	20
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	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	Comprimidos de liberación controlada de clorhidrato de oxicodona (Oxycontin®)
D.2.1.1.2	Name of the Marketing Authorisation holder	Purdue Pharma L.P.
D.2.1.2	Country which granted the Marketing Authorisation	United States
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	Comprimidos de liberación controlada de clorhidrato de oxicodona dos veces al día
D.3.2	Product code	Oxycodone HCl CR
D.3.4	Pharmaceutical form	Tablet
D.3.4.1	Specific paediatric formulation	No
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	clorhidrato de oxicodona
D.3.9.2	Current sponsor code	OTR3002
D.3.9.3	Other descriptive name	N/A
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	30
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: 5
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	Comprimidos de liberación controlada de clorhidrato de oxicodona(Oxycontin®)
D.2.1.1.2	Name of the Marketing Authorisation holder	Purdue Pharma L.P.
D.2.1.2	Country which granted the Marketing Authorisation	United States
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	Comprimidos de liberación controlada de clorhidrato de oxicodona dos veces al día.
D.3.2	Product code	Oxicodona HCl CR
D.3.4	Pharmaceutical form	Tablet
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Auricular use Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	clorhidrato de oxicodona
D.3.9.2	Current sponsor code	OTR3002
D.3.9.3	Other descriptive name	N/A
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	40
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

Opioid experienced paediatric patients aged 6-17 years with moderate to severe malignant and/or nonmalignant pain requiring opioid therapy.

Pacientes pediátricos de entre 6 y 17 años, ya expuestos a los opiáceos y aquejados de dolor oncológico y/o no oncológico de carácter moderado a intenso que necesitan tratamiento con opiáceos

E.1.1.1

Medical condition in easily understood language

Pain due to cancer or other causes

Dolor de origen oncológico o no oncológico

E.1.1.2

Therapeutic area

Diseases [C] - Nervous System Diseases [C10]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	14.0
E.1.2	Level	LLT
E.1.2	Classification code	10002182
E.1.2	Term	Analgesia
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

El objetivo principal es caracterizar la seguridad a largo plazo de los comprimidos de oxicodona HCl LC en pacientes pediátricos de entre 6 y 17 años inclusive, ya expuestos a los opiáceos y aquejados de dolor oncológico y/o no oncológico de carácter moderado a intenso que necesitan tratamiento con opiáceos, después de que terminen el período de tratamiento de 4 semanas del estudio OTR3001.

E.2.2

Secondary objectives of the trial

No aplica

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1) Sexo masculino o femenino y edad comprendida entre los 6 y los 17 años inclusive; haber terminado las 4 semanas de tratamiento del estudio OTR3001 y seguir beneficiándose, a juicio del investigador, de continuar el tratamiento con oxicodona HCl LC con una dosis de entre 20 mg y 240 mg al día para el alivio del dolor moderado o intenso de origen oncológico o no oncológico.
2) Tolerancia del tratamiento con oxicodona HCl LC en el estudio OTR3001, reflejada al inicio del estudio en lo siguiente:
- Frecuencia respiratoria normal según la edad.
- Ausencia en la visita 1 de somnolencia significativa (grado 3 ó 4) inducida por los opiáceos, según la University of Michigan Sedation Scale (UMSS) y a juicio del investigador.
- El criterio clínico del investigador.
3) Voluntad y capacidad de tragar enteros los comprimidos de oxicodona HCl LC.
4) En el caso de las niñas que hayan pasado la menarquia, dar negativo a la prueba del embarazo en la visita 3 del OTR3001 y no estar en período de lactancia.
5) Contar con padres/tutores que realicen todas las evaluaciones del estudio —incluida la valoración con la UMSS— y que anoten las dosis de los comprimidos de oxicodona HCl LC y todas las dosis de los analgésicos complementarios.
6) Si la paciente es sexualmente activa, deberá usar un método anticonceptivo válido.
7) Tanto en el caso del paciente como de los padres/tutores, voluntad y capacidad de ceñirse al protocolo, capacidad de evaluar al paciente, voluntad y capacidad de llevar un diario y capacidad de leer, comprender y firmar el documento de consentimiento informado y/o de asentimiento.

E.4

Principal exclusion criteria

1) Acontecimientos adversos aparecidos en el OTR3001 que sigan en curso y que, a juicio del investigador, constituyan motivo de exclusión del estudio de extensión.
2) Embarazo o lactancia.
3) Necesidad de una dosis de opiáceos equivalente a < 20 mg al día ó > 240 mg al día de oxicodona para el tratamiento del dolor de origen oncológico o no oncológico.
4) Alergia a la oxicodona o antecedentes de alergia a otros opiáceos (sin contar los efectos secundarios habituales como las náuseas o el estreñimiento).
5) Tratamiento con inhibidores moderados o potentes del CYP3A4 si la dosis no ha sido estable durante al menos 1 mes.
6) Previsión de iniciar tratamiento con inhibidores moderados o potentes del CYP3A4 durante el estudio, después de la visita de selección (véase el apartado 9.5.3 Tratamientos anteriores, prohibidos y concomitantes y el Apéndice C, que recoge una lista de los inhibidores moderados y potentes del CYP3A4 [según la directriz de la FDA de 2006]).
7) Cianosis postoperatoria.
8) Antecedentes de apnea del sueño en el último año.
9) Antecedentes de fibrosis quística.
10) Presencia de síndrome de malabsorción.
11) Presencia de íleo paralítico.
12) Necesidad de ventilación mecánica.
13) Contraindicación del consumo de opiáceos.
14) Tratamiento de mantenimiento actual con metadona contra el dolor.
15) Esperanza de vida inferior a las 2 semanas.
16) Alteraciones de las constantes vitales, la exploración física o las analíticas de relevancia suficiente para que el investigador considere al paciente no apto para el estudio.
17) Disfunción hepática, evidenciada por una alanina-aminotransferasa (ALT) o aspartato-aminotransferasa (AST) > 5 veces el límite superior de la normalidad (LSN) propio de la edad.
18) Signos de disfunción renal (creatinina sérica > 2 veces el LSN propio de la edad).
19) Previsión de intervención quirúrgica durante el período del estudio, salvo para colocación de vías de acceso venoso centrales o periféricas.
20) Inaptitud para participar en el estudio, a juicio del investigador, por cualquier otro motivo.
21) Tratamiento con un medicamento/tratamiento en investigación aparte del fármaco del estudio (oxicodona HCl LC) en la selección o durante el estudio.

E.5 End points

E.5.1

Primary end point(s)

Analisis de seguridad:

Las variables de seguridad se presentarán segun las características demográficas y basales de la población de seguridad y de la población de seguridad de la extensión. La seguridad se evaluará a partir de los AA, las exploraciones físicas, los análisis clínicos, las constantes vitales y la somnolencia (UMSS).

E.5.1.1

Timepoint(s) of evaluation of this end point

Se realizarán mediciones de las constantes vitales a los pac. antes y tras el incremento de la dosis.La 1ª dosis incrementada la tomarán en el centro,se determinarán las constantes vitales antes y al cabo de 30,60 y 90 min.En el caso de los hospitalizados el cuadro clínico puede ser inestable,se determinarán las constantes vitales nuevamente al cabo de 3 y 4 h,y cada 4 horas hasta que hayan transcurrido 48 h de la toma de la dosis incrementada(es decir, entre las dosis 2.ª y 5.ª). Los padres/tutores evaluarán y anotarán la somnolencia con la UMSS alrededor del momento de la toma de la dosis incrementada de oxicodona HCl LC y tras 24 h y 48 h. Se documentarán todos los AA. Análisis clínicos en el día 1, sem. 4, sem.12 y sem. 24

E.5.2

Secondary end point(s)

N/A

E.5.2.1

Timepoint(s) of evaluation of this end point

N/A

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

E.6.4

Safety

Yes

E.6.5

Efficacy

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

E.8.1.2

Open

Yes

E.8.1.3

Single blind

E.8.1.4

Double blind

E.8.1.5

Parallel group

E.8.1.6

Cross over

E.8.1.7

Other

Yes

E.8.1.7.1

Other trial design description

Si el paciente es ambulatorio, se le dispensará comprimidos de oxicodona HCl, según las instruccione

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

Estudio abierto, sin placebo

E.8.2.4

Number of treatment arms in the trial

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

Yes

E.8.5.1

Number of sites anticipated in the EEA

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

Yes

E.8.6.2

Trial being conducted completely outside of the EEA

E.8.6.3

If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned

Belgium

Bulgaria

Croatia

Estonia

Finland

Germany

Guatemala

India

Israel

Panama

Poland

Romania

Slovakia

Spain

Sweden

United Kingdom

United States

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

El estudio comprende un máximo de 6 meses de tratamiento con el fármaco en investigación (7 visitas en consulta/evaluaciones) y un seguimiento de 7 a 10 días

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:

135

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:

F.1.1.6

Adolescents (12-17 years)

Yes

F.1.1.6.1

Number of subjects for this age range:

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

Yes

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

El consentimiento informado del estudio se obtendrá de todos los pacientes padres/tutores.
El asentimiento del menor se documentará de conformidad con las normas del CEIC del centro y los reglamentos de aplicación.

F.3.3.7

Others

Yes

F.3.3.7.1

Details of other specific vulnerable populations

Pacientes pediatricos de 6 a 17 años

F.4 Planned number of subjects to be included

F.4.1

In the member state

F.4.2

For a multinational trial

F.4.2.1

In the EEA

F.4.2.2

In the whole clinical trial

135

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)

Según protocolo (seccion 9.3).

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

2011-10-26

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2011-10-10

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2013-12-09

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IMP with orphan designation in the indication
Orphan Designation Number:
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