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    The EU Clinical Trials Register currently displays   43861   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:2007-005781-12
    Sponsor's Protocol Code Number:A6631013
    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:2008-02-14
    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 number2007-005781-12
    A.3Full title of the trial
    ESTUDIO EN FASE 2A, DE CUATRO SEMANAS DE DURACIÓN, MULTICÉNTRICO, ALEATORIZADO, DOBLE CIEGO, CONTROLADO CON PLACEBO Y DE GRUPOS PARALELOS CON PH-797804 EN EL TRATAMIENTO DE LA NEURALGIA POSTHERPÉTICA


    A FOUR WEEK, MULTI-CENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP, PHASE 2A STUDY OF PH-797804 IN THE TREATMENT OF POST-HERPETIC NEURALGIA
    A.4.1Sponsor's protocol code numberA6631013
    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 SponsorPFIZER
    B.1.3.4CountrySpain
    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 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.3.2Product code PH-797804
    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.3.9.1CAS number 586414-48-4
    D.3.9.2Current sponsor codePH-797804
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number3
    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 No
    D.3.11.3.2Gene therapy medical product No
    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 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 Information not present in EudraCT
    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
    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
    Neuralgia Posterpetica

    Post-herpetic neuralgia (PHN)
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10036376
    E.1.2Term Post herpetic neuralgia
    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 PH 797804 en pacientes con neuralgia postherpética.
    • Evaluar la seguridad y la tolerabilidad de PH 797804 en pacientes con neuralgia postherpética.
    • Recoger muestras de sangre para análisis farmacocinético de PH 797804 en pacientes con neuralgia postherpética.
    E.2.2Secondary objectives of the trial
    No aplicable
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Varones y mujeres mayores de 18 años
    2. Las mujeres no deberán ser fértiles. Se considerará mujeres no fértiles a las siguientes:
    • Mujeres mayores de 60 años de edad.
    • Mujeres de 45 60 años de edad que lleven amenorreicas al menos 2 años y tengan una concentración sérica de FSH >30 UI/l en ausencia de tratamiento hormonal sustitutivo o se hayan sometido a histerectomía u ooforectomía documentadas.
    3. Los pacientes deberán haber tenido dolor presente durante más de 3 meses después de la curación de las lesiones cutáneas del herpes zoster. No se ha definido el límite superior de la duración de la NPH.
    4. Los pacientes deben tener una puntuación ≥40 mm en la escala analógica visual (EAV) del dolor en la visita 1
    5. Los pacientes deben ser capaces de comprender los procedimientos del ensayo y prestar su cooperación y habrán firmado un consentimiento informado por escrito antes de ser incluidos en el ensayo
    E.4Principal exclusion criteria
    Pacientes sometidos a tratamiento neurolítico o neuroquirúrgico, incluidas las escisiones cutáneas, por NPH.
    Pacientes con otro dolor intenso que pueda influir en la autoevaluación del dolor debido a NPH.
    Antecedentes de hepatitis crónica B o C, hepatitis aguda B o C en los 3 últimos meses o infección por el VIH.
    Antecedentes de alcoholismo o toxicomanía en los 2 últimos años.
    Antecedentes de cáncer (distinto del basocelular cutáneo) en los 5 años previos.
    Antecedentes en el año previo de: infarto de miocardio, arritmia cardiaca, insuficiencia ventricular izquierda, insuficiencia cardiaca congestiva de clase III IV (NYHA) que exija tratamiento, angina inestable, angioplastia coronaria, injerto de derivación de arteria coronaria (IDAC) o accidente cerebrovascular (incluidos ataques isquémicos transitorios).
    Tuberculosis no tratada y/o reacción positiva a la tuberculina (DPP) sin que se sepa si ha recibido la vacuna de Calmette Guerin (BCG)
    Una prueba sanguínea por inmunoensayo aprobado/ELISA positiva para TB, cuando se realice.
    Antecedentes en los 6 meses previos de: Una crisis epiléptica, diabetes de tipo 1 ó 2 mal controlada, Hepatitis aguda de cualquier etiología.
    Que presenten: cualquier trastorno que pueda afectar a la absorción oral de los fármacos; cualquier lesión cutánea de importancia clínica descrita en los Criterios de Terminología Comunes para AAs para dermatología (CTCAE); cualquier infección activa de importancia clínica; insuficiencia cardiaca congestiva que exija tratamiento de clase III IV de la (NYHA)
    Una operación quirúrgica importante en el mes previo a la selección.
    Anomalías del ECG en la selección o en la aleatorización, incluidas las enumeradas a continuación. El investigador decidirá si anomalías del ECG distintas de las citadas tienen importancia clínica y deben obligar a excluir al paciente del reclutamiento: los sujetos con signos antes de la aleatorización de prolongación del QTc en (V1) o en V2 (definidas como >450 ms) no son elegibles para aleatorización. Esta valoración se basa en una media confirmada de registros del ECG por triplicado y la realiza el investigador en el momento de la obtención del ECG; ritmo cardíaco predominante distinto del ritmo sinusal normal; Bloqueo auriculoventricular (AV) de grado superior al grado I; frecuencia cardíaca en reposo >100 o <40 lpm; signos de infarto de miocardio previo en ausencia de antecedentes clínicos compatibles con estos hallazgos; evidencia de isquemia aguda.
    Datos de disfunción orgánica o de trastorno hematopoyético, a juzgar por cualquiera de las siguientes evaluaciones:
    Hb <10 g/dl, Hct <32 %; Recuento absoluto de leucocitos <3,0 x 109/l (<3000/mm3); Recuento de neutrófilos <1,2 x 109/l (<1.200/mm3); Recuento de plaquetas <100 x 109/l (<100.000/mm3); AST o ALT >1,2 x LSN; Bilirrubina total >1,2 x LSN; Fosfatasa alcalina >1,2 x LSN;Albúmina <3,5 g/dl o 35 g/l debido a hepatopatía conocida; Creatinina sérica >LSN
    Uso de cualquiera de las medicaciones concomitantes prohibidas en el plazo temporal previo al inicio de la selección o durante el período preinclusión..
    Uso de cualquier fármaco en investigación en el mes o las 5 semividas anteriores a la selección, lo que sea más largo.
    Antecedentes de hipersensibilidad inducida por fármacos grave (anafilaxia).
    Pacientes con depresión grave a juicio del investigador o con trastorno depresivo mayor según los criterios diagnósticos del DSM IV o una puntuación de la subescala de depresión >10 en la Escala de ansiedad y depresión hospitalaria.
    Pacientes a los que se atribuya un riesgo importante de suicidio.
    Incapacidad para comprender, o falta de disposición para seguir, los requisitos del estudio, incluidas la asistencia a las visitas clínicas ambulatorias y la participación en los análisis de laboratorio exigidas por el protocolo.
    Trastornos médicos o psicológicos inestables o clínicamente importantes que, a criterio del investigador, puedan poner en peligro la participación en el estudio.
    E.5 End points
    E.5.1Primary end point(s)
    Escala de valoración diaria del dolor
    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 No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    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 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) 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) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.3 The trial involves single site in the Member State concerned Information not present in EudraCT
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA25
    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 Yes
    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 years0
    E.8.9.1In the Member State concerned months9
    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 months9
    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 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 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 Information not present in EudraCT
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    F.3.3.3Pregnant women Information not present in EudraCT
    F.3.3.4Nursing women Information not present in EudraCT
    F.3.3.5Emergency situation Information not present in EudraCT
    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 state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 56
    F.4.2.2In the whole clinical trial 80
    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 Decision2008-03-10
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-01-31
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2008-12-05
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