Clinical Trials Register

Summary
EudraCT Number:	2011-000245-20
Sponsor's Protocol Code Number:	FSJD-RAL-2010
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:	2012-01-24
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

2011-000245-20

A.3

Full title of the trial

ENSAYO CLÍNICO DOBLE CIEGO A SEIS MESES, CONTROLADO CON PLACEBO, DE LA EFICACIA DE RALOXIFENO COMO TRATAMIENTO ADYUVANTE DE LOS SÍNTOMAS NEGATIVOS DE LA ESQUIZOFRENIA, EN MUJERES POSTMENOPÁUSICAS

"A 6-month double-blind, placebo-controlled study of efficacy of raloxifene as an adjuvant treatment for negative symptoms of schizophrenia in postmenopausal women."

A.3.1

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

ENSAYO CLÍNICO DOBLE CIEGO A SEIS MESES, CONTROLADO CON PLACEBO, DE LA EFICACIA DE RALOXIFENO COMO TRATAMIENTO ADYUVANTE DE LOS SÍNTOMAS NEGATIVOS DE LA ESQUIZOFRENIA, EN MUJERES POSTMENOPÁUSICAS

A.4.1

Sponsor's protocol code number

FSJD-RAL-2010

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	FUNDACIÓ SANT JOAN DE DEU
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	Ministerio de Sanidad
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	FUNDACIÓ SANT JOAN DE DEU
B.5.2	Functional name of contact point	Rosa María Morales
B.5.3	Address:
B.5.3.1	Street Address	C/Sant Rosa,39-57, 4ª planta,
B.5.3.2	Town/ city	Esplugas de Llobregat/ Barcelona
B.5.3.3	Post code	08950
B.5.3.4	Country	Spain
B.5.4	Telephone number	936009751
B.5.5	Fax number	936009771
B.5.6	E-mail	rmorales@fjd.org

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	OPTRUMA 60 mg comprimidos recubiertos con película
D.2.1.1.2	Name of the Marketing Authorisation holder	ELI LILLY NEDERLAND BV
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	OPTRUMA 60 mg
D.3.4	Pharmaceutical form	Film-coated 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	RALOXIFENO HIDROCLORURO
D.3.9.3	Other descriptive name	RALOXIFENE 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	60
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	Capsule
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

SINTOMAS NEGATIVOS EN ESQUIZOFRENIA

E.1.1.1

Medical condition in easily understood language

SÍNTOMAS ESQUIZOFRENIA

E.1.1.2

Therapeutic area

Psychiatry and Psychology [F] - Mental Disorders [F03]

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

El objetivo primario del ensayo clínico es evaluar la eficacia del raloxifeno (SERM Selective Estrogen Receptor Modulator, Modulador Selectivo de los Receptores de Estrógeno) como adyuvante del tratamiento antipsicótico, en el manejo de los síntomas negativos de la esquizofrenia en mujeres postmenopáusicas.

E.2.2

Secondary objectives of the trial

1. Evaluar la eficacia del raloxifeno como adyuvante del tratamiento antipsicótico, en el manejo de los síntomas globales de la esquizofrenia en mujeres postmenopáusicas.
2. Evaluar la eficacia del raloxifeno como adyuvante del tratamiento antipsicótico, en el funcionamiento global de las mujeres postmenopáusicas con esquizofrenia.
3. Evaluar la eficacia del raloxifeno como adyuvante del tratamiento antipsicótico, en el funcionamiento neuropsicológico de las mujeres postmenopáusicas con esquizofrenia.
4. Controlar la respuesta al tratamiento en función de las variantes genéticas del tipo SNP (del inglés Single Nucleotide Polymorphism) que las pacientes presenten en los genes de los receptores estrogénicos alfa (ESR1) y beta (ESR2).
5. Evaluar la seguridad de la medicación empleada en esta población de pacientes.

E.2.3

Trial contains a sub-study

Yes

E.2.3.1

Full title, date and version of each sub-study and their related objectives

Sub-estudio genético que tiene como objetivo evaluar el además de valorar la influencia de los polimorfismos genéticos en la respuesta al tratamiento. Se adjunta aparte(HIP_CI_GENETICO_FSJD-RAL-10_VERSIÓN 1.0_18/01/2011).

E.3

Principal inclusion criteria

1. Diagnóstico de esquizofrenia según criterios DSM-IV TR.
2. Pacientes postmenopáusicas. Se define postmenopausia como 1) mayor de 45 años y niveles de FSH mayores de 20 UI/L ó 2) mayor de 50 años con al menos un año de amenorrea.
3. Pacientes que estén tomando una dosis estable de medicación antipsicótica durante al menos los 30 días previos al inicio del estudio.
4. Presencia de síntomas negativos significativos (definidos como uno o más síntomas negativos con una gravedad de más de 4 en la escala PANSS)
5. Consentimiento informado general por escrito de las pacientes o su representante legal.
6. Para la realización del estudio genotípico, las pacientes o su representante legal deberán otorgar un consentimiento informado específico para ello.

E.4

Principal exclusion criteria

1.Diagnóstico de trastorno por abuso/dependencia de sustancias en los 6 meses previos.
2. Retraso mental
3. Diagnóstico de depresión mayor (según los criterios del DSM-IV TR).
4. Alteraciones endocrinas, enfermedad hepatica aguda o crónica, alteración renal.
5. Historial o patología actual de tromboembolismo, cáncer de mama, sangrado uterino anormal o accidente cerebrovascular.
6. Pacientes en terapia hormonal sustitutiva.
7. Alergia o hipersensibilidad conocida al principio activo del fármaco en investigación, a cualquiera de sus excipientes o a la lactosa.
8. Tratamiento en otro ensayo clínico.
9. Cualquier enfermedad concomitante grave que en la opinión del investigador pueda comprometer completar el estudio o afectar la tolerancia del paciente para este tratamiento.
10.Embarazo.

E.5 End points

E.5.1

Primary end point(s)

La variable primaria de eficacia será el cambio en la puntuación de la subescala negativa de la PANSS desde el inicio del tratamiento, a la valoración a las 24 semanas.
Se comparará las puntuaciones al inicio y a la finalización del tratamiento.
Se considerará respuesta al tratamiento como una reducción en la puntuación de la subescala negativa de la PANSS de al menos el 20% desde el inicio del tratamiento.

E.5.1.1

Timepoint(s) of evaluation of this end point

valoración a las 24 semanas

E.5.2

Secondary end point(s)

Se recogerán las siguientes variables secundarias, desde el inicio del tratamiento a la valoración de seguimiento, que será a las 4,12 y 24 semanas para las escalas, y únicamente a las 12 y 24 semanas para los tests neuropsicológicos:
1. Cambio en las puntuaciones de la escala SANS.
2. Cambio en las puntuaciones de la escala PANSS positiva, general y total.
3. Cambio en la severidad de la escala CGI de la enfermedad.
4. Valoración de todas las demás escalas y tests neuropsicológicos empleados.
5. Valoración de la proporción de pacientes que han experimentado acontecimientos adversos.

E.5.2.1

Timepoint(s) of evaluation of this end point

a las 12 y 24 semanas para los tests neuropsicológicos:

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

Yes

E.6.6

Pharmacokinetic

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

Yes

E.6.11

Pharmacogenomic

Yes

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

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

LA VISITA DEL ÚLTIMO PACIENTE, SERA EL FINAL DEL ESTUDIO

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

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:

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

F.2 Gender

F.2.1

Female

Yes

F.2.2

Male

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

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

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)

NO APLICA

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

2011-06-21

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2011-05-05

P. End of Trial
P.	End of Trial Status	Completed

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