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    The EU Clinical Trials Register currently displays   44334   clinical trials with a EudraCT protocol, of which   7366   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:2007-004733-41
    Sponsor's Protocol Code Number:A6061037
    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:2010-03-08
    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 number2007-004733-41
    A.3Full title of the trial
    “ESTUDIO ALEATORIZADO, DOBLE CIEGO, CONTROLADO CON PLACEBO DE [S,S]-REBOXETINA EN PACIENTES CON NEUROPATIA PERIFERICA DOLOROSA CRÓNICA” Y SUPLEMENTO DE DETERMINACIÓN DEL PERFIL MOLECULAR

    A RANDOMIZED, DOUBLE-BLIND PLACEBO CONTROLLED TRIAL OF [S,S]-REBOXETINE IN PATIENTS WITH CHRONIC PAINFUL DIABETIC PERIPHERAL NEUROPATHY
    A.4.1Sponsor's protocol code numberA6061037
    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. S.A
    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.3.1Product name[S,S]-Reboxetine Succinate
    D.3.2Product code PNU-165442G
    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.3.8INN - Proposed INN[S,S]-reboxetine succinate
    D.3.9.2Current sponsor codePNU-165442G
    D.3.9.3Other descriptive name(2S)-2-[(S)-(2-ethoxyphenoxy) phenylmethyl] morpholine succinate
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2
    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.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 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 name[S,S]-Reboxetine Succinate
    D.3.2Product code PNU-165442G
    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.3.8INN - Proposed INN[S,S]-reboxetine succinate
    D.3.9.2Current sponsor codePNU-165442G
    D.3.9.3Other descriptive name(2S)-2-[(S)-(2-ethoxyphenoxy) phenylmethyl] morpholine succinate
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number4
    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 placeboTablet
    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
    PACIENTES CON NEUROPATÍA DIABÉTICA PERIFÉRICA DOLOROSA CRÓNICA
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10012683
    E.1.2Term Diabetic peripheral neuropathy
    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 la [S,S] RBX en pacientes con NDP
    •Evaluar la seguridad y la tolerabilidad de la [S,S] RBX en pacientes con NDP
    E.2.2Secondary objectives of the trial
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    •Varones y mujeres de cualquier raza y mayores de 18 años
    •Las mujeres deberán estar posmenopáusicas o esterilizadas quirúrgicamente o bien (si están en edad fértil) no podrán estar embarazadas ni lactando y tendrán que usar métodos anticonceptivos apropiados. Antes del comienzo del ensayo, se recomienda encarecidamente que las mujeres en edad fértil utilicen dos de los siguientes anticonceptivos durante un mes como mínimo o durante el tiempo que dichos métodos tarden en ser totalmente eficaces en opinión del médico encargado de la prescripción: píldora anticonceptiva, diafragma, implantes de progesterona, acetato de medroxiprogesterona o preservativo. Las mujeres en edad fértil deberán tener un resultado negativo confirmado en una prueba de embarazo en orina en la visita de selección (visita 1) y en la visita 2
    •Diagnóstico de diabetes mellitus de tipo 1 ó 2 (conforme a los criterios diagnósticos recogidos en las Recomendaciones para la práctica clínica de la American Diabetic Association, www.diabetes.org) desde hace al menos 1 año.
    •Concentración de hemoglobina A1c ≤11 % en la visita 1 (se permiten fluctuaciones ≤1 % en las 6 a 12 semanas anteriores a la visita 1)
    •Diagnóstico de polineuropatía sensitivomotora simétrica, distal, dolorosa, causada por la diabetes, desde hace al menos 1 año (véanse los criterios diagnósticos, Apéndice 1)
    •Los pacientes deben tener una puntuación 40 mm en la escala analógica visual (EAV) del dolor en la visita 1
    •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
    •Neoplasia maligna en los 2 últimos años, con la excepción del carcinoma basocelular
    •Pacientes con afectación hepática importante (p. ej., AST/ALT >3 x LSN, bilirrubina total >2 x LSN)
    •Alteración clínicamente significativa en el ECG de 12 derivaciones (en opinión del investigador)
    •Trastornos neurológicos no relacionados con la neuropatía diabética que pueden confundir la evaluación del dolor neuropático
    •Dolor u otro proceso que pueda confundir la valoración o la autoevaluación del dolor debido a la neuropatía diabética
    •Antecedentes de hepatitis crónica B o C, hepatitis aguda A, B o C en los 3 últimos meses o infección por el VIH
    •Enfermedades cutáneas en la zona afectada por la neuropatía que, en opinión del investigador, pudieran alterar la sensibilidad
    •Amputaciones que no sean de los dedos de los pies
    •Administración de cualquier fármaco o agente en investigación en los 30 días anteriores a la selección
    •Uso de medicamentos prohibidos sin dejar el período de lavado apropiado
    •Abuso de drogas/fármacos o de alcohol en los dos años anteriores
    •Puntuación >10 en la subescala de depresión de la Escala hospitalaria de ansiedad y depresión
    •Diagnóstico actual o reciente (en los últimos 6 meses) o episodio de trastorno depresivo mayor (diagnosticado a partir de la MINI) y/o depresión no controlada (distimia diagnosticada a partir de la MINI)
    •Antecedentes de manía, hipomanía, trastorno psicótico o trastorno del estado de ánimo actual con rasgos psicóticos
    •Paciente que, basándose en el juicio clínico, presente un riesgo grave de suicidio conforme a la Escala de ideas de suicidio de Beck
    •Antecedentes de síncope recurrente o indicios de hipotensión (PA sistólica <90 mm Hg, PA diastólica <40 mm Hg).
    •Hipotensión postural (disminución de 20 mm Hg en la presión arterial sistólica o de 10 mm Hg en la presión arterial diastólica en bipedestación).
    •Antecedentes de accidente isquémico transitorio o de ictus
    •Infarto de miocardio o angina inestable en los últimos tres meses
    •Soplo carotídeo, salvo que se haya descartado una estenosis carotídea significativa (p. ej., >70 %) mediante investigaciones apropiadas
    •Antecedentes de retención urinaria
    •Antecedentes de glaucoma de ángulo estrecho no controlado
    •Pacientes que tengan antecedentes de trastornos convulsivos, incluidas las crisis alcohólicas, antecedentes familiares de crisis o antecedentes de traumatismo craneal que provocara pérdida del conocimiento o conmoción cerebral
    •Exposición previa a [S,S] RBX o la reboxetina racémica (Edronax®)
    •Cualquier enfermedad grave o inestable que, en opinión del investigador, pueda poner en peligro la participación en el ensayo
    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 No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    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 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 No
    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 concerned7
    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 years1
    E.8.9.1In the Member State concerned months3
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months4
    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 Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    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 state28
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 94
    F.4.2.2In the whole clinical trial 450
    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 Decision2008-01-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-01-11
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2008-11-06
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