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    The EU Clinical Trials Register currently displays   43857   clinical trials with a EudraCT protocol, of which   7284   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2004-002591-42
    Sponsor's Protocol Code Number:10225
    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:2012-03-15
    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
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedSpain - AEMPS
    A.2EudraCT number2004-002591-42
    A.3Full title of the trial
    A pharmacoeconomic study conducted in parallel with clinical trial 10200, a 24-week double-blind, risperidone-referenced, flexible dose, parallel-group extension study of bifeprunox in patients with schizophrenia
    Estudio de farmacoeconomía desarrollado en paralelo al ensayo clínico 10200, un estudio de extensión de 6 meses con bifeprunox, doble ciego, con risperidona como fármaco de referencia, dosis flexible, con grupos paralelos, en pacientes con esquizofrenia
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A pharmacoeconomic study conducted in parallel with clinical trial 10200
    Estudio de farmacoeconomía desarrollado en paralelo al ensayo clínico 10200
    A.4.1Sponsor's protocol code number10225
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorH.Lundbeck A/S
    B.1.3.4CountryDenmark
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportH.Lundbeck A/S
    B.4.2CountryDenmark
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationLundbeck España S.A.
    B.5.2Functional name of contact pointMedical Dircetor
    B.5.3 Address:
    B.5.3.1Street AddressAvenida Diagonal 605
    B.5.3.2Town/ cityBarcelona
    B.5.3.3Post code08028
    B.5.3.4CountrySpain
    B.5.4Telephone number34934949620
    B.5.5Fax number34934949660
    B.5.6E-mailshed@lundbeck.com
    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 No
    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 nameBifeprunox
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    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 INNBIFEPRUNOX
    D.3.9.1CAS number 350992-10-8
    D.3.9.2Current sponsor codeLu 02-754/DU 127090
    D.3.9.4EV Substance CodeSUB20312
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number30 to 40
    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) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 2
    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 Yes
    D.2.1.2Country which granted the Marketing AuthorisationDenmark
    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 nameRisperidone
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.1CAS number 106266-06-2
    D.3.9.3Other descriptive nameRISPERIDONE
    D.3.9.4EV Substance CodeSUB10335MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number4 to 6
    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) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another 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.1.1Medical condition(s) being investigated
    Schizophrenia
    Esquizofrenia
    E.1.1.1Medical condition in easily understood language
    Schizophrenia
    Esquizofrenia
    E.1.1.2Therapeutic area Psychiatry and Psychology [F] - Mental Disorders [F03]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10039626
    E.1.2Term Schizophrenia
    E.1.2System Organ Class 10037175 - Psychiatric disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate and compare the costs and patient-reported outcomes (PRO) of 24-week treatment with either bifeprunox or risperidone in patients with schizophrenia, having completed the pharmacoeconomic study 10224
    Evaluar y comparar los costes y los resultados en salud referidos por el paciente del tratamiento durante 6 meses con bifeprunox o risperidona en pacientes con esquizofrenia, que hayan completado el estudio de farmacoeconomía 10224
    E.2.2Secondary objectives of the trial
    None
    Ninguno
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. The patient or patient?s authorized legal representative must understand the nature of the study and must have given written informed consent.
    2. The patient must have completed study 10199 immediately prior to enrolment into the extension study.
    3. On the basis of a physical examination, medical history, electrocardiogram, blood biochemistry, haematology tests and a urinalysis carried out at the Termination Visit of study 10199, the patient is, in the investigator?s opinion, otherwise healthy.
    4. A female patient of child-bearing potential may be enrolled provided that she:
    b. has a negative pregnancy test (blood serum beta-HCG) prior to Visit 1 (= Termination Visit of study 10199), and
    c. is routinely using one of the following medically acceptable methods of birth
    control:
    i. oral contraception at a stable dose for at least 3 months prior to entry into the study
    ii. the first dose of medroxyprogesterone or other i.m. injection administered at least 2 months prior to entry into the study, and has been maintaining the recommended administration schedule.
    iii. implementation of levonorgestrel system or an inta-uterine device for at least 2 months prior to entry into the study
    iv. barrier methods (combination of diaphragm and spermicidal or condom and spermicide) prior to and during the trial, and
    c. is not breast feeding, and
    d. agrees not to become pregnant during the trial
    1. El paciente o el representante legal del paciente debe comprender la naturaleza del ensayo y debe haber dado su consentimiento informado por escrito.
    2. El paciente debe haber finalizado el ensayo 10199 inmediatamente antes de ser incluido en el estudio de extensión.
    3. Pacientes con un buen estado de salud, en opinión del investigador, basándose en la exploración física, el historial médico, el electrocardiograma, los análisis de sangre bioquímico y hematológico y el análisis de orina realizados en la Visita de Finalización del ensayo 10199.
    4. Una mujer con potencial para quedar embarazada podría ser incluida en el estudio siempre que:
    a. tenga un test de embarazo negativo (suero sanguíneo beta-HCG) previo a la Visita 1 (= Visita de Finalización del ensayo 10199), y
    b. esté utilizando de forma habitual uno de los siguientes métodos para el control de la natalidad aceptados médicamente:
    i. contracepción oral a dosis estables durante al menos los 3 meses previos a la inclusión en el ensayo
    ii. la primera dosis de medroxiprogesterona u otra inyección i.m. administrada al menos en los 2 meses previos a la inclusión en el ensayo, y que se haya mantenido el calendario recomendado de administración
    iii. implementación del sistema levonorgestrel o un dispositivo intrauterino en al menos los 2 meses previos a la inclusión en el ensayo
    iv. métodos de barrera (combinación de diafragma y espermicida o preservativo y espermicida) antes y durante el ensayo, y
    c.no esté en periodo de lactancia, y
    d.esté de acuerdo en no quedarse embarazada durante el ensayo
    E.4Principal exclusion criteria
    Patients meeting any of the exclusion criteria applying for patients at entry to study 10199, except for exclusion criteria 19 (hospitalisation for the current episode for more than four weeks), 23 (need for continuous treatment with anticholinergic drugs), 24 (exposure to any investigational drug within 60 days prior to study entry), and 26 (prior exposure to bifeprunox), cannot be included in the study
    No pueden ser incluidos en el ensayo los pacientes que cumplan algún criterio de exclusión requerido para el ensayo 10199, excepto para el criterio de exclusión 19 (hospitalización por el episodio psicótico actual durante más de cuatro semanas), 23 (necesidad de tratamiento continuo con fármacos anticolinérgicos), 24 (exposición a un fármaco en investigación 60 días previos a la Visita Basal) y 26 (exposición previa a bifeprunox)
    E.5 End points
    E.5.1Primary end point(s)
    Sociodemographic data
    Cost & Patient-Reported Outcome Assessments: Quality of life (S-QoL); Adherance to treatment (DAI)
    Use of resources (CSRI)
    Datos sociodemográficos
    Costes y resultados en salud referidos por el paciente: calidad de vida (S-QoL); Adherencia al tratamiento (DAI)
    Uso de recursos (CSRI)
    E.5.1.1Timepoint(s) of evaluation of this end point
    PE 1: is the baseline visit of the pharmacoeconomic study. It will take place at the same time as visit 2 of clinical trial 10200, i.e. week 0.
    PE 2: is the second visit of the pharmacoeconomic study. It will take place at the same time as visit 4 of clinical trial 10200, i.e. end of week 12.
    PE 3: is the final visit of the pharmacoeconomic study. It will take place at the same time as the termination visit of clinical trial 10200 or at withdrawal, i.e. end of week 24.
    PE 1: es la Visita Basal del estudio de farmacoeconomía. Se realizará en el mismo momento en que se realice la Visita 1 del ensayo clínico 10200, es decir, en el Mes 0.
    PE 2: es la segunda visita del estudio de farmacoeconomía. Se realizará en el mismo momento que la Visita 4 del ensayo clínico 10200, es decir, al final del Mes 3.
    PE 3: es la visita final del estudio de farmacoeconomía. Se realizará en el mismo momento que la Visita de Finalización del ensayo clínico 10200 o en el momento de la retirada, es decir, al final del Mes 6.
    E.5.2Secondary end point(s)
    Not applicable
    No aplica
    E.5.2.1Timepoint(s) of evaluation of this end point
    Not applicable
    No aplica
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety No
    E.6.5Efficacy No
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic Yes
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned13
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA50
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Belgium
    Germany
    Greece
    Hong Kong
    Malaysia
    Netherlands
    Philippines
    Spain
    Sweden
    Thailand
    E.8.7Trial has a data monitoring committee No
    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
    ? safety concerns
    ? proven lack of efficacy from other completed studies
    ? the investigator does not comply with the protocol, Good Clinical Practice, and/or any contract between the investigator and H. Lundbeck A/S, including affiliates and subsidiaries hereof
    ? Preocupaciones relativas a la seguridad.
    ? Demostración de la falta de eficacia del fármaco en investigación, mediante otros ensayos clínicos finalizados.
    ? El investigador no cumple con el protocolo, las directrices de Buena Práctica Clínica y/o cualquier contrato suscrito entre el investigador y H. Lundbeck A/S, incluyendo sus afiliados y subsidiarias.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months6
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 60
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 10
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state70
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 210
    F.4.2.2In the whole clinical trial 320
    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)
    None
    Ninguno
    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 Decision2004-10-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2004-05-04
    P. End of Trial
    P.End of Trial StatusOngoing
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