Clinical Trial Page

Summary
EudraCT Number:2004-004281-32
Sponsor's Protocol Code Number:SJDSSM-2
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:2005-06-07
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
A. Protocol Information
A.1Member State ConcernedSpain - AEMPS
A.2EudraCT number2004-004281-32
A.3Full title of the trial
“Double blind, placebo-controlled study of efficacy, safety and tolerance of raloxifene as an adjuvant treatment for negative symptoms of schizophrenia in postmenopausal women”
Estudio doble ciego controlado con placebo de la eficacia, seguridad y tolerancia del raloxifeno como tratamiento coadyuvante de los síntomas negativos de la esquizofrenia en mujeres postmenopáusicas.
A.4.1Sponsor's protocol code numberSJDSSM-2
A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
A.8EMA Decision number of Paediatric Investigation Plan
B. Sponsor Information
B.Sponsor: 1
B.1.1Name of SponsorSan Joan de Déu. Serveis de Salut Mental
B.1.3.4CountrySpain
B.3.1 and B.3.2Status of the sponsorNon-Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1Name of organisation providing support
B.4.2Country
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1Name of organisation
B.5.2Functional name of contact point
D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3IMP RoleTest
D.2 Status of the IMP to be used in the clinical trial
D.2.1IMP to be used in the trial has a marketing authorisation Information not present in EudraCT
D.2.1.1.1Trade name Evista
D.2.1.1.2Name of the Marketing Authorisation holderEli lilly Nederland B.V.
D.2.1.2Country which granted the Marketing AuthorisationSpain
D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
D.2.5.1Orphan drug designation number
D.3 Description of the IMP
D.3.1Product nameraloxifeno
D.3.4Pharmaceutical form Capsule*
D.3.4.1Specific paediatric formulation Information not present in EudraCT
D.3.7Routes of administration for this IMPOral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8INN - Proposed INNRaloxifeno
D.3.10 Strength
D.3.10.1Concentration unit mg milligram(s)
D.3.10.2Concentration typeequal
D.3.10.3Concentration number60
D.3.11 The IMP contains an:
D.3.11.1Active substance of chemical origin Yes
D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Information not present in EudraCT
The IMP is a:
D.3.11.3Advanced Therapy IMP (ATIMP) Information not present in EudraCT
D.3.11.3.1Somatic cell therapy medicinal product Information not present in EudraCT
D.3.11.3.2Gene therapy medical product Information not present in EudraCT
D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
D.3.11.5Radiopharmaceutical medicinal product Information not present in EudraCT
D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) Information not present in EudraCT
D.3.11.7Plasma derived medicinal product Information not present in EudraCT
D.3.11.8Extractive medicinal product Information not present in EudraCT
D.3.11.9Recombinant medicinal product Information not present in EudraCT
D.3.11.10Medicinal product containing genetically modified organisms Information not present in EudraCT
D.3.11.11Herbal medicinal product Information not present in EudraCT
D.3.11.12Homeopathic medicinal product Information not present in EudraCT
D.3.11.13Another type of medicinal product Information not present in EudraCT
D.8 Information on Placebo
D.8 Placebo: 1
D.8.1Is a Placebo used in this Trial?Yes
D.8.3Pharmaceutical form of the placeboCapsule*
D.8.4Route of administration of the placeboOral use
E. General Information on the Trial
E.1 Medical condition or disease under investigation
E.1.1Medical condition(s) being investigated
Trastorno esquizofrénico
MedDRA Classification
E.1.3Condition being studied is a rare disease No
E.2 Objective of the trial
E.2.1Main objective of the trial
Evaluar la eficacia de añadir raloxifeno como coadyuvante del tratamiento antipsicótico en la mejora de los síntomas negativos de la esquizofrenia en mujeres posmenopáusicas.

E.2.2Secondary objectives of the trial
a)Evaluar la eficacia del raloxifeno como coadyuvante del tratamiento antipsicótico en la mejora de otros síntomas psicóticos y del funcionamiento social y global en mujeres con esquizofrenia postmenopáusicas.
b) Evaluar la seguridad y tolerancia del raloxifeno como coadyuvante del tratamiento antipsicótico en mujeres con esquizofrenia
E.2.3Trial contains a sub-study Information not present in EudraCT
E.3Principal inclusion criteria
- Diagnóstico de esquizofrenia según criterios DSM-IV
- Pacientes mujeres posmenopáusicas. Se considerará que la paciente está en la posmenopausia si hace un año o más que no presenta la menstruación y tiene unos niveles de la hormona foliculoestimulante (FSH) > 20IU/L.
-Que esté tomando una dosis estable de medicación antipsicótica durante al menos un mes antes del inicio del estudio. Las pacientes deberán seguir tomando la misma medicación sin cambios de dosis a lo largo del estudio.
-Presencia de síntomas negativos significativos (definidos como uno o más síntomas negativos con una gravedad de más de 4 en la escala PANSS) (Kay 1987).
-Pacientes que se visitan de forma ambulatoria.
-Las pacientes deberán dar su consentimiento informado por escrito.
E.4Principal exclusion criteria
- Diagnóstico de esquizofrenia según criterios DSM-IV
- Pacientes mujeres posmenopáusicas. Se considerará que la paciente está en la posmenopausia si hace un año o más que no presenta la menstruación y tiene unos niveles de la hormona foliculoestimulante (FSH) > 20IU/L.
-Que esté tomando una dosis estable de medicación antipsicótica durante al menos un mes antes del inicio del estudio. Las pacientes deberán seguir tomando la misma medicación sin cambios de dosis a lo largo del estudio.
-Presencia de síntomas negativos significativos (definidos como uno o más síntomas negativos con una gravedad de más de 4 en la escala PANSS) (Kay 1987).
-Pacientes que se visitan de forma ambulatoria.
-Las pacientes deberán dar su consentimiento informado por escrito.
E.5 End points
E.5.1Primary end point(s)
- La Escala de Síndromes Positivos y Negativos de la Esquizofrenia (The Positive and Negative Symptom Score:PANNS) (Kay et al 1991; Cuesta y Peralta, 1994).
- La Escala de Impresión Clínica Global (Clinical Global Impression: The CGI-severity of illness score) (Guy 1976, Haro, 2003)
- La Escala de Evaluación Global (Global Assessment Functioning: GAF ) (APA, 1994; APA, 1995)
- El Perfil de Habilidades de la Vida Cotidiana (The Living Skills Profile: LSP) (Rosen et al, 1989; Fernández, 1992)
- The Calgary Depression Scale for Schizophrenia (CDSS) (Addington et al, 1990)
- The Simpson Scale (Simpson and Angus, 1970), modificado para incluir la acatisia.
- La Escala de Evaluación de Efectos Secundarios UKU (The UKU side effect rating scale) (Lingjaerde et al, 1987)
- Recogida de acontecimientos adversos o patologías intercurrentes comunicadas espontáneamente.
- Se recogerá el uso medicación concomitante y las dosis.

E.6 and E.7 Scope of the trial
E.6Scope of the trial
E.6.1Diagnosis Information not present in EudraCT
E.6.2Prophylaxis Information not present in EudraCT
E.6.3Therapy Yes
E.6.4Safety Yes
E.6.5Efficacy Yes
E.6.6Pharmacokinetic Information not present in EudraCT
E.6.7Pharmacodynamic Information not present in EudraCT
E.6.8Bioequivalence Information not present in EudraCT
E.6.9Dose response Information not present in EudraCT
E.6.10Pharmacogenetic Information not present in EudraCT
E.6.11Pharmacogenomic Information not present in EudraCT
E.6.12Pharmacoeconomic Information not present in EudraCT
E.6.13Others Information not present in EudraCT
E.7Trial type and phase
E.7.1Human pharmacology (Phase I) Information not present in EudraCT
E.7.1.1First administration to humans Information not present in EudraCT
E.7.1.2Bioequivalence study Information not present in EudraCT
E.7.1.3Other Information not present in EudraCT
E.7.1.3.1Other trial type description
E.7.2Therapeutic exploratory (Phase II) Information not present in EudraCT
E.7.3Therapeutic confirmatory (Phase III) Information not present in EudraCT
E.7.4Therapeutic use (Phase IV) Yes
E.8 Design of the trial
E.8.1Controlled Yes
E.8.1.1Randomised Yes
E.8.1.2Open Information not present in EudraCT
E.8.1.3Single blind Information not present in EudraCT
E.8.1.4Double blind Yes
E.8.1.5Parallel group Information not present in EudraCT
E.8.1.6Cross over Information not present in EudraCT
E.8.1.7Other Information not present in EudraCT
E.8.2 Comparator of controlled trial
E.8.2.1Other medicinal product(s) Information not present in EudraCT
E.8.2.2Placebo Yes
E.8.2.3Other Information not present in EudraCT
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 Information not present in EudraCT
E.8.5The trial involves multiple Member States Information not present in EudraCT
E.8.6 Trial involving sites outside the EEA
E.8.6.1Trial being conducted both within and outside the EEA Information not present in EudraCT
E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
E.8.7Trial has a data monitoring committee Information not present in EudraCT
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
-Acontecimiento adverso clínicamente significativo que impida la continuación del estudio.
-Efecto inadecuado del tratamiento que requiere una aproximación terapéutica no permitida en el protocolo.
-Necesidad de instaurar un tratamiento adicional no permitido en el protocolo.
-Decisión del paciente o retirada del consentimiento.
-Solicitud del promotor
-Juicio clínico
E.8.9 Initial estimate of the duration of the trial
E.8.9.1In the Member State concerned years3
E.8.9.1In the Member State concerned months
E.8.9.1In the Member State concerned days
F. Population of Trial Subjects
F.1 Age Range
F.1.1Trial has subjects under 18 No
F.1.1.1In Utero Information not present in EudraCT
F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
F.1.1.3Newborns (0-27 days) Information not present in EudraCT
F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
F.1.1.5Children (2-11years) Information not present in EudraCT
F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
F.1.2Adults (18-64 years) Yes
F.1.3Elderly (>=65 years) Yes
F.2 Gender
F.2.1Female Yes
F.2.2Male No
F.3 Group of trial subjects
F.3.1Healthy volunteers No
F.3.2Patients Yes
F.3.3Specific vulnerable populations Information not present in EudraCT
F.3.3.1Women of childbearing potential not using contraception No
F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
F.3.3.3Pregnant women No
F.3.3.4Nursing women No
F.3.3.5Emergency situation No
F.3.3.6Subjects incapable of giving consent personally Information not present in EudraCT
F.3.3.7Others Information not present in EudraCT
F.4 Planned number of subjects to be included
F.4.1In the member state36
G. Investigator Networks to be involved in the Trial
N. Review by the Competent Authority or Ethics Committee in the country concerned
N.Competent Authority Decision Authorised
N.Date of Competent Authority Decision2004-12-21
N.Ethics Committee Opinion of the trial applicationFavourable
N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
N.Date of Ethics Committee Opinion2004-07-20
P. End of Trial
P.End of Trial StatusOngoing

Sponsors and Collaborators

Medical Conditions

Drug Interventions

3
Subscribe