Clinical Trials Register

Summary
EudraCT Number:	2010-023061-21
Sponsor's Protocol Code Number:	2010-2739
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:	2010-11-04
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

2010-023061-21

A.3

Full title of the trial

ensayo clínico sobre efectos de la metformina en la obesidad pediátrica: efectos en el peso corporal, perfil de biomarcadores inflamatorios y de riesgo cardiovascular, e impacto en factores relacionados con el síndrome metabólico "Clinical trial on the effect of metformin in pediatric obesity: effects on body weight, profile and inflammatory biomarkers of cardiovascular risk, and impact on factors related to metabolic syndrome"

A.3.1

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

Efectos de la metformina en la obesidad infantil

A.3.2

Name or abbreviated title of the trial where available

met-obesid

A.4.1

Sponsor's protocol code number

2010-2739

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	Ramón Cañete Estrada
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 Salud Carlos III
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	Caïber Hospital Reina Sofía
B.5.2	Functional name of contact point	Caïber
B.5.3	Address:
B.5.3.1	Street Address	Avda Menendez Pidal s/n
B.5.3.2	Town/ city	Córdoba
B.5.3.3	Post code	14004
B.5.3.4	Country	Spain
B.5.4	Telephone number	34957011227
B.5.5	Fax number	34957011227
B.5.6	E-mail	cetico.hrs.sspa@juntadeandalucia.es

D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	No
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	Metformina
D.3.4	Pharmaceutical form	Powder for oral suspension
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	METFORMINA HIDROCLORURO
D.3.9.3	Other descriptive name	METFORMIN HYDROCHLORIDE
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	500
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No

D.8 Information on Placebo
D.8 Placebo: 1
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Powder for oral solution
D.8.4	Route of administration of the placebo	Oral use

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Obesidad en niños prepuberales y puberales.

E.1.1.1

Medical condition in easily understood language

Obesidad

E.1.1.2

Therapeutic area

Diseases [C] - Nutritional and Metabolic Diseases [C18]

MedDRA Classification

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

Estudiar el impacto clínico y bioquímico de la administración de metformina junto con el cambio de estilos de vida (dieta y ejercicio) en el niño obeso

E.2.2

Secondary objectives of the trial

1) Evaluar la efectividad de la metformina en la reducción del IMC. 2) Analizar los efectos de la metformina en la insulinorresistencia inherente al SM, estudiando el perfil bioquímico (sanguíneo) hidrocarbonado. 3) Examinar los efectos de la metformina en el metabolismo lipídico, biomarcadores inflamatorios y de riesgo cardiovascular. 4) Conocer la existencia y grado de esteatosis hepática en los niños obesos prepúberes y púberes y el potencial efecto de la metformina en el tratamiento de esta entidad, en términos de función (bioquímica) y morfología (ecográfica) hepáticas

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1º Niños obesos con edades entre los 7-14 años prepúberes y púberes, de género masculino y femenino, con obesidad exógena,
2º No deben tener enfermedad de base o antecedentes de patología.
3º Estos pacientes requieren no haber recibido tratamiento médico y/o dietético que pudiera interferir en los resultados analíticos doce meses antes.
4º No está permitida la inclusión del mismo paciente más de una vez.
5º No haber participado en un ensayo anterior

E.4

Principal exclusion criteria

1º Se descartarán aquellos pacientes que no cumplan la edad establecida
2º Que presenten o hayan presentado alguna enfermedad de base anteriormente
3º Aquéllos que reciban o hayan recibido medicación con efectos secundarios metabólicos, como diuréticos, β-bloqueantes, β-adrenérgicos, corticoides).
4º También se excluirán los niños sometidos a largos periodos de reposo.

E.5 End points

E.5.1

Primary end point(s)

La variable principal es el índice de masa corporal (IMC) y en función de ella se ha calculado el tamaño muestral.
Esta variable principal (IMC) pertenecería al grupo de variables antropométricas que se pretenden estudiar. Además de éstas, se valorarán los estilos de vida, se procederá a elaborar una historia clínica y se realizarán sendas extracciones sanguíneas.

E.5.1.1

Timepoint(s) of evaluation of this end point

Inicio, semana 8, semana 16 y semana 24

E.5.2

Secondary end point(s)

Tensión arterial, analítica sanguínea (con perfil lipídico, hidrocarbonado, inflamatorio y oxidativo) y encuesta de estilos de vida.

E.5.2.1

Timepoint(s) of evaluation of this end point

Tensión arterial (Inicio, semana 8, semana 16 y semana 24), analítica sanguínea (con perfil lipídico, hidrocarbonado, inflamatorio y oxidativo) al inicio y en a semana 24; y encuesta de estilos de vida al inicio.

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

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

Yes

E.8.1.5

Parallel group

Yes

E.8.1.6

Cross over

E.8.1.7

Other

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

E.8.2.2

Placebo

Yes

E.8.2.3

Other

E.8.2.4

Number of treatment arms in the trial

E.8.3

The trial involves single site in the Member State concerned

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

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 considerará final del ensayo la fecha de la última visita (t3) del último sujeto reclutado (semana 24 de tratamiento de este último sujeto)

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:

160

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

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

Prepuberes y puberes= menores de edad

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

160

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)

A la finalización del ensayo, la supresión de la metformina no constituye riesgo alguno para el paciente, en virtud de la evidencia científica disponible. De cualquier forma, cada facultativo responsable manifestará su disponibilidad en relación al tema objeto del ensayo, no sólo durante, sino incluso después de concluir el periodo de seguimiento, por un semestre. La probada seguridad de la metformina no exige pruebas adicionales a las consideradas en el cronograma/esquema de actuación.

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

2011-11-07

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2011-10-14

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

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