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    Summary
    EudraCT Number:2005-003694-25
    Sponsor's Protocol Code Number:PA18604
    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:2005-11-28
    Trial results View 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 number2005-003694-25
    A.3Full title of the trial
    Ensayo randomizado, doble ciego, con doble enmascaramiento, de grupos paralelos para evaluar la eficacia y seguridad de RO4402257 como monoterapia en comparación con la monoterapia de metotrexato para pacientes con artritis reumatoide activa (AR)

    A randomized, double-blind, double-dummy, parallel group study to determine the efficacy and safety of RO4402257 monotherapy in comparison to methotrexate monotherapy in patients with active rheumatoid arthritis (RA).
    A.4.1Sponsor's protocol code numberPA18604
    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 SponsorF. Hoffmann-La Roche Ltd
    B.1.3.4CountrySwitzerland
    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 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.2.5The 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 nameP38 (4) Map Kinase Inhibitor
    D.3.2Product code RO4402257
    D.3.4Pharmaceutical form Film-coated tablet
    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.3.9.2Current sponsor codeRO4402257
    D.3.9.3Other descriptive nameP38(4) Map Kinase Inhibitor
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    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) 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.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 Information not present in EudraCT
    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 nameP38 (4) Map Kinase Inhibitor
    D.3.2Product code RO4402257
    D.3.4Pharmaceutical form Film-coated tablet
    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.3.9.2Current sponsor codeRO4402257
    D.3.9.3Other descriptive nameP38(4) Map Kinase Inhibitor
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number75
    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) 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.IMP: 3
    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.2.5The 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 nameP38 (4) Map Kinase Inhibitor
    D.3.2Product code RO4402257
    D.3.4Pharmaceutical form Film-coated tablet
    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.3.9.2Current sponsor codeRO4402257
    D.3.9.3Other descriptive nameP38(4) Map Kinase Inhibitor
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number150
    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) 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.IMP: 4
    D.1.2 and D.1.3IMP RoleComparator
    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 Methotrexate Sodium 2.5mg Tablets
    D.2.1.1.2Name of the Marketing Authorisation holderCyanamid of Great Britain Ltd
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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 nameMethotrexate Sodium 2.5mg Tablets
    D.3.2Product code PL 00095/5079R
    D.3.4Pharmaceutical form Tablet
    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.3.9.3Other descriptive nameMethotrexate Sodium 2.5mg Tablets
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2.5
    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) 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 placeboFilm-coated tablet
    D.8.4Route of administration of the placeboOral use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCapsule, hard
    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
    Artritis Reumatoide
    Rheumatoid Arthritis
    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 RO4402257 como monoterapia en pacientes adultos con AR activa.

    E.2.2Secondary objectives of the trial
    1.Evaluar el perfil de seguridad de RO4402257 como monoterapia en pacientes con AR.

    Evaluar la eficacia y seguridad de varios niveles de dosificación de RO4402257.

    Recoger datos de farmacocinética que puedan combinarse con los datos farmacocinéticos de otros estudios RO4402257 para estudiar el perfil farmacocinético de RO4402257 de la población de pacientes con AR mediante un enfoque de análisis poblacional




    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    Pacientes capaces y dispuestos a dar su consentimiento informado por escrito y a cumplir con el protocolo del estudio.

    Pacientes con AR activa diagnosticada según los criterios de 1987 del Colegio Americano de Reumatología (ACR, antes Asociación Americana de Reumatismo) (Apéndice 2).

    Edad ≥18 años.

    Está recibiendo tratamiento para la AR de forma ambulatoria.

    Recuento de articulaciones inflamadas (SJC) ≥ 6 (sobre un recuento de articulaciones de 66) y recuento de articulaciones dolorosas (TJC) ≥ 8 (sobre un recuento de articulaciones de 68) durante la selección y la visita basal.

    En la preselección, tener una proteína C reactiva de alta sensibilidad (se-PCR) ≥ 0,6 mg/dl (6 mg/l), o una velocidad de sedimentación globular (VSG) ≥ 28 mm/h o rigidez matutina ≥ 45 minutos

    Mujeres en edad fértil o varones no esterilizados con compañeras fértiles que acepten utilizar métodos anticonceptivos fiables (como una barrera física, la píldora anticonceptiva, el parche o el DIU) durante el estudio y las 4 semanas después de la última dosis del fármaco del estudio

    Si es mujer en edad fértil, deberá dar negativo en una prueba del embarazo realizada en las 3 semanas antes de la aleatorización y la visita basal (antes de la administración del fármaco del estudio el día 1)



    E.4Principal exclusion criteria
    Generales

    Cirugía mayor (incluida la cirugía articular) en las 8 semanas anteriores a la selección , o cualquier intervención quirúrgica prevista en los 3 meses siguientes a la aleatorización.

    Enfermedad autoinmunitaria reumática distinta a la AR, (incluido el lupus eritomatoso sistémico, enfermedad mixta del tejido conectivo, esclerodermia, polimiositis) o implicación sistémica significativa secundaria a la AR (por ejemplo, vasculitis, fibrosis pulmonar o síndrome de Felty). Si se permite el síndrome de Sjögren junto con la AR.

    Postración o confinado al uso de silla de ruedas.

    Antecedentes o enfermedades articulares inflamatorias actuales distintas a la AR (por ejemplo, gota, artritis reactiva, artritis psoriásica, espondiloartropatía seronegativa, enfermedad de Lyme).

    Exclusiones por medicación previa o concomitante

    Tratamiento con MTX en las 8 semanas antes de la visita basal.

    Interrupción de la administración previa de MTX debido a toxicidad clínicamente significativa o a una falta de eficacia en dosis terapéuticas establecidas por el investigador.

    Uso de sulfasalazina, azatioprina, ciclosporina, talidomida, D-penicilamina, hidroxicloroquina, cloroquina, aurotiomalato sódico o tacrolimus en las 3 semanas antes de la visita basal; uso de leflunomida en las 8 semanas (o 4 semanas tras 11 días de lavado convencional con colestiramina) antes de la visita basal.

    Dosis de corticoesteroides mayor a los 10 mg/día de prednisona (o equivalente, véase el Apéndice 1).

    Tratamiento concomitante con cualquier FAME, incluidos los anti-TNF u otra terapia biológica para la AR.

    Exposición previa a terapias anti-TNF o anti-IL-1 que tuvieran como resultado aspectos problemáticos de seguridad significativos o falta de eficacia. Se permitirá a aquellos pacientes que interrumpieron la terapia debido al coste o intolerancia de las infusiones o inyecciones, pero deben haberlo hecho antes de la visita basal de la siguiente forma: etanercept > 2 semanas, infliximab o adalimumab > 8 semanas, anakinra > 2 semanas.

    Tratamiento con otros agentes en investigación durante las 6 semanas o 5 semividas (el plazo que sea más largo) antes de la visita de selección.

    Tratamiento previo con cualquier terapia reductora de células, incluyendo fármacos en investigación (por ejemplo, CAMPATH, anti-CD4, anti-CD5, anti-CD3, anti-CD19 y anti-CD20); columnas de inmunoabsorción en los 6 meses antes de la visita basal.

    Tratamiento previo con agentes alquilantes.

    Corticoesteroides intraarticulares o parenterales en las 4 semanas previas a la visita basal.

    Exclusiones por motivos generales de seguridad

    Signos de enfermedades concomitantes graves no controladas como enfermedades cardiovasculares, del sistema nervioso, pulmonares (incluido el asma), renales, hepáticas, endocrinas (incluida la diabetes mellitus no controlada) o gastrointestinales.

    Antecedentes de cáncer, lo que incluye tumores sólidos y hematológicos, salvo carcinoma basocelular cutáneo extirpado y curado)

    Alguno de los siguientes casos:
    • Antecedentes de tuberculosis activa.
    • Radiografía de tórax que indique tuberculosis latente o activa.
    • Positivo en la prueba del derivado proteico de la tuberculina (PPD) (≥ 10 mm de induración) a no ser que haya antecedentes confirmados de inmunización BCG y el investigador compruebe que no hay antecedentes recientes de exposición a la tuberculosis.

    Casos de infecciones activas conocidas bacterianas (incluidas la micobacterianas), víricas (incluido el VIH), fúngicas u otras infecciones (a excepción de las micosis del lecho ungueal).

    Cualquier episodio de infección que hubiere requerido hospitalización o tratamiento con antibióticos por vía intravenosa en las 4 semanas anteriores a la visita basal o antibióticos por vía orales en las 2 semanas anteriores a la visita basal.

    Antecedentes de síndrome de inmunodeficiencia adquirida o hereditaria.

    Antecedentes de infecciones bacterianas recurrentes en la edad adulta.

    Inmunización con una vacuna elaborada con microbios vivos en las 4 semanas previas a la visita basal.

    Mujeres embarazadas o lactancia materna.

    Antecedentes de alcoholismo o abuso de sustancias tóxicas en los 6 meses previos a la selección.

    Neuropatías u otras afecciones dolorosas que puedan interferir en la evaluación del dolor.

    Exclusiones de laboratorio durante la selección

    Alanina aminotransferasa (ALT/SGPT) o aspartato aminotransferasa (AST/SGOT) > 1,5 veces el LSN en el momento de la selección.

    Aclaramiento de creatinina calculado durante la selección (Cockroft-Gault ) < 50 ml/minuto (consúltese la fórmula de Cockroft-Gault, véase el Apéndice 3)











    E.5 End points
    E.5.1Primary end point(s)
    La variable principal de eficacia es la proporción de pacientes que obtienen una respuesta ACR20 en la semana 12.

    Según los criterios de respuesta del Colegio Americano de Reumatología, para obtener una respuesta ACR20 se necesita un 20% de mejora, en comparación con el estado basal, tanto en las articulaciones inflamadas como en las dolorosas, así como en al menos 3 de los siguientes 5 parámetros: valoración global del médico respecto a la actividad de la enfermedad, valoración global del paciente respecto a la actividad de la enfermedad, evaluación del paciente respecto al dolor, HAQ y un reactante de fase aguda, ya sea hs-CRP o VSG.

    Por “basal” se entiende al estado inmediatamente anterior a la primera administración del fármaco del estudio (día 1).

    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 Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic Information not present in EudraCT
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic No
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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.8.3 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.8.5The trial involves multiple Member States Yes
    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 Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months5
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months5
    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) No
    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 Information not present in EudraCT
    F.3.3.1Women of childbearing potential not using contraception For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2005-11-28. Yes
    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 No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state13
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 84
    F.4.2.2In the whole clinical trial 200
    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 Decision2006-01-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2006-01-13
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2007-06-21
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