Clinical Trials Register

Summary
EudraCT Number:	2008-001542-57
Sponsor's Protocol Code Number:	PI0428/2007
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:	2008-08-12
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

2008-001542-57

A.3

Full title of the trial

EFECTIVIDAD DE LA SUPLEMENTACIÓN ANTIOXIDANTE PARA PREVENIR LA PROGRESIÓN CLÍNICA EN EL GLAUCOMA

A.4.1

Sponsor's protocol code number

PI0428/2007

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	Manuel García Medina
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	oftan macula
D.2.1.1.2	Name of the Marketing Authorisation holder	Laboratorios Dr Esteve
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	oftan macula
D.3.2	Product code	Complemento vitaminico
D.3.4	Pharmaceutical form	Capsule*
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	VITAMINA A
D.3.9.3	Other descriptive name	VITAMINA A
D.3.10	Strength
D.3.10.1	Concentration unit	µg microgram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	800
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	VITAMINA B1
D.3.9.3	Other descriptive name	VITAMINA B1
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	1.4
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	VITAMINA B2
D.3.9.3	Other descriptive name	VITAMINA B2
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	1.6
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	NIACINA
D.3.9.3	Other descriptive name	NIACINA
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	18
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	VITAMINA B6
D.3.9.3	Other descriptive name	VITAMINA B6
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	2
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	FOLICO ACIDO
D.3.9.1	CAS number	59-30-3
D.3.9.3	Other descriptive name	FOLIC ACID
D.3.10	Strength
D.3.10.1	Concentration unit	µg microgram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	200
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	VITAMINA B12
D.3.9.3	Other descriptive name	VITAMINA B12
D.3.10	Strength
D.3.10.1	Concentration unit	µg microgram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	1
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	VITAMINA C
D.3.9.3	Other descriptive name	VITAMINA C
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	60
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	VITAMINA E
D.3.9.3	Other descriptive name	VITAMINA E
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	6.7
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	PROTEINAS
D.3.9.3	Other descriptive name	PROTEINS NOS
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	121.4
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	hidratos de carbono
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	48.2
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	MAGNESIO
D.3.9.1	CAS number	138-37-4
D.3.9.3	Other descriptive name	MAGNESIUM
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	45
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	SELENIO
D.3.9.3	Other descriptive name	SELENIUM
D.3.10	Strength
D.3.10.1	Concentration unit	µg microgram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	25
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	COBRE
D.3.9.3	Other descriptive name	COPPER
D.3.10	Strength
D.3.10.1	Concentration unit	µg microgram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	1000
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	ZINC
D.3.9.1	CAS number	7440-66-6
D.3.9.3	Other descriptive name	ZINC
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	7.5
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Luteina
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	6
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	zeaxantina
D.3.9.1	CAS number	144-68-3
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	0.24
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	MANGANESO
D.3.9.1	CAS number	7439-96-5
D.3.9.3	Other descriptive name	MANGANESE
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	1
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	TRIGLICERIDOS OMEGA-3
D.3.9.3	Other descriptive name	OMEGA-3 TRIGLYCERIDES
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	194.4
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	Yes
D.2.1.1.1	Trade name	Icaps
D.2.1.1.2	Name of the Marketing Authorisation holder	Complemento Vitaminico
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	Icaps
D.3.2	Product code	Complemento vitaminico
D.3.4	Pharmaceutical form	Capsule*
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	ACIDOS OMEGA 3
D.3.9.3	Other descriptive name	ACIDOS OMEGA 3
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	280
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	VITAMINA C
D.3.9.3	Other descriptive name	VITAMINA C
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	60
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	NIACINA
D.3.9.3	Other descriptive name	NIACINA
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	18
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	VITAMINA E
D.3.9.3	Other descriptive name	VITAMINA E
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.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	ZINC
D.3.9.1	CAS number	7440-66-6
D.3.9.3	Other descriptive name	ZINC
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	6
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	VITAMINA B6
D.3.9.3	Other descriptive name	VITAMINA B6
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	2
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	MANGANESO
D.3.9.1	CAS number	7439-96-5
D.3.9.3	Other descriptive name	MANGANESE
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	2
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	VITAMINA B2
D.3.9.3	Other descriptive name	VITAMINA B2
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	1.6
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	VITAMINA B1
D.3.9.3	Other descriptive name	VITAMINA B1
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	1.4
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	COBRE
D.3.9.3	Other descriptive name	COPPER
D.3.10	Strength
D.3.10.1	Concentration unit	µg microgram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	1000
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	VITAMINA A
D.3.9.3	Other descriptive name	VITAMINA A
D.3.10	Strength
D.3.10.1	Concentration unit	µg microgram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	800
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	FOLICO ACIDO
D.3.9.1	CAS number	59-30-3
D.3.9.3	Other descriptive name	FOLIC ACID
D.3.10	Strength
D.3.10.1	Concentration unit	µg microgram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	200
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	SELENIO
D.3.9.3	Other descriptive name	SELENIUM
D.3.10	Strength
D.3.10.1	Concentration unit	µg microgram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	40
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	VITAMINA B12
D.3.9.3	Other descriptive name	VITAMINA B12
D.3.10	Strength
D.3.10.1	Concentration unit	µg microgram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	1
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	lut
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	6
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	Yes
D.3.11.13.1	Other medicinal product type	Complemento alimenticio multivitamínico

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

Efecto neuroprotector de los suplementos vitamínicos en el glaucoma

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	9
E.1.2	Level	LLT
E.1.2	Classification code	10018304
E.1.2	Term	Glaucoma

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 de este trabajo es comparar la progresión clínica a largo plazo en dos grupos de pacientes glaucomatosos con presión intraocular controlada (PIO<21mmHg): uno suplementado con antioxidantes a dosis nutricionales y otro sin suplementación.

E.2.2

Secondary objectives of the trial

1. Evaluar la ingesta de antioxidantes en la dieta, factores de estilo de vida e indicadores de calidad de vida en una población glaucomatosa significativa en nuestro medio.

2. Valorar la eficacia de la suplementación antioxidante como refuerzo de la ingesta en dieta atendiendo a la progresión glaucomatosa individual y a los factores de estilo de vida individuales (mediante estudio de correlación múltiple).De esta manera se busca encontrar posibles perfiles de pacientes con características concretas que puedan obtener especial beneficio clínico de la suplementación antioxidante.

3. Estimar el impacto de la progresión del glaucoma en los hábitos dietéticos, en los factores de estilo de vida y en los indicadores de calidad de vida de los pacientes.

4. Establecer un modelo de coste/efectividad de la suplementación antioxidante en el glaucoma.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

Los criterios de inclusión serán los siguientes:
-Pacientes diagnosticados previamente de glaucoma y en tratamiento con fármacos hipotensores.
-PIO inferiores a 21 mmHg en las dos últimas visitas previas a la inclusión en el estudio.
-Al menos con un campo visual previo (para evitar el efecto aprendizaje), independientemente de su fiabilidad
-Los campos visuales para el estudio habrá de tener una fiabilidad suficiente (pérdidas de fijación<20%, falsos positivos<33% y falsos negativos<33%).

E.4

Principal exclusion criteria

Los criterios de exclusión son los siguientes:
-Padecer alguna enfermedad sistémica que pueda alterar el metabolismo Redox como diabetes mellitus, neoplasia, insuficiencia renal, etc.
-Padecer alguna enfermedad ocular o neurológica que pueda interferir en los resultados del campo visual como neuropatías ópticas no glaucomatosa, enfermedades desmielinizantes, etc.
-Padecer alguna enfermedad psiquiátrica que pueda disminuir la atención en la realización del campo visual como Alzheimer, Down, etc.
-Padecer o haber sufrido cáncer ya que no sería posible achacar la progresión o no a este factor.
-Padecer alguna patología vascular. En las personas con diabetes y patologías vasculares la vitamina E puede tener riesgo de alteraciones cardiacas.
-Ser fumador, porque se conoce que en los fumadores los suplementos de Beta carotenos pueden inducir cáncer de pulmón.

E.5 End points

E.5.1

Primary end point(s)

Plan del estudio y variables
Se realizarán semestralmente controles oftalmológicos completos que incluirán las siguientes exploraciones por el siguiente: Agudeza visual mejor corregida (en escala decimal), Campimetría automatizada con la mejor corrección, medición de PIO mediante tonometría de aplanación Goldmann con corrección mediante paquimetría, retinografía con estudio morfométrico del nervio óptico (con cálculo de la excavación papilar expresada entre 0 –no excavación- y 1 –excavación total-). Si en algún momento del estudio la PIO sube por encima de 20 en algún paciente se sustituirán o añadirán fármacos hipotensores con la intención de volver a controlar la PIO pero no se excluirá a tal paciente (para valorar si los antioxidantes tienen algún efecto sobre la PIO y la progresión clínica).
En la exploración del campo visual (perimetría automatizada) se usará una estrategia blanco-blanco, 24-2, considerándose para el cálculo estadístico los siguiente índices:
1- Defecto medio (DM). Representa la medida media de cuánto está deprimido el campo visual de un paciente (comparado con una persona normal de la misma edad). Se considera normal entre -2 y +2 decibelios. Un valor elevado en ausencia de otra patología es indicativo de glaucoma (pérdida generalizada de la sensibilidad). Esta variable es la variable operativa principal.
2- Varianza de la pérdida de sensibilidad (DSM). Representa la homogeneidad del campo visual. Se considera normal con valores entre 0 y 3 decibelios. Valores elevados indican la presencia de defectos profundos y localizados (típicos de los escotomas arciformes del glaucoma)
Asimismo se le entregarán 3 cuestionarios sencillos y de rápida realización a cada paciente que habrá remitir por correo (con portes pagados por el hospital) a los centros de estudio en un plazo de 7 días tras la visita oftalmológica. En caso contrario se les llamarán por teléfono para reclamarlo. Los cuestionarios son los siguientes: el Cuestionario Frecuencia de Consumo Alimentario Semanal (CFCS) estándar, el cuestionario de factores de estilo de vida y el cuestionario de calidad de vida estándar SF-36 que ya ha sido utilizado en pacientes con glaucoma (Parish RK II, Gedde SJ, Scott IU et al. Visual function and quality of life among patients with glaucoma. Arch Ophthalmol 1997; 115: 1447–1455; Sherwood MB, Garcia-Siekavizza A, Meltzer MI et al. Glaucoma’s impact on quality of life and its relation to clinical indicators. A pilot study. Ophthalmol 1998; 105: 561–566)

Se valorarán los cambios en cada paciente tomando como referencia los resultados de las exploraciones en la primera visita (baseline).

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

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)

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

Yes

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

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

grupo sin tratamiento

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

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

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	No
F.1.1.1	In Utero	Information not present in EudraCT
F.1.1.2	Preterm newborn infants (up to gestational age < 37 weeks)	Information not present in EudraCT
F.1.1.3	Newborns (0-27 days)	Information not present in EudraCT
F.1.1.4	Infants and toddlers (28 days-23 months)	Information not present in EudraCT
F.1.1.5	Children (2-11years)	Information not present in EudraCT
F.1.1.6	Adolescents (12-17 years)	Information not present in EudraCT
F.1.2	Adults (18-64 years)	Yes
F.1.3	Elderly (>=65 years)	Yes
F.2 Gender
F.2.1	Female	Yes
F.2.2	Male	Yes
F.3 Group of trial subjects
F.3.1	Healthy volunteers	No
F.3.2	Patients	Yes
F.3.3	Specific vulnerable populations	No
F.3.3.1	Women of childbearing potential not using contraception	Information not present in EudraCT
F.3.3.2	Women of child-bearing potential using contraception	Information not present in EudraCT
F.3.3.3	Pregnant women	Information not present in EudraCT
F.3.3.4	Nursing women	Information not present in EudraCT
F.3.3.5	Emergency situation	Information not present in EudraCT
F.3.3.6	Subjects incapable of giving consent personally	Information not present in EudraCT
F.3.3.7	Others	Information not present in EudraCT
F.4 Planned number of subjects to be included
F.4.1	In the member state	100

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

2008-11-05

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2008-01-31

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

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IMP with orphan designation in the indication
Orphan Designation Number:
Results Status:
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