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    Summary
    EudraCT Number:2008-000844-15
    Sponsor's Protocol Code Number:A6111139
    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:2008-04-10
    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 number2008-000844-15
    A.3Full title of the trial
    ESTUDIO ABIERTO EN FASE 1 DE LAS CONCENTRACIONES PLASMÁTICAS DEL ÁCIDO DE LATANOPROST EN PACIENTES PEDIÁTRICOS Y ADULTOS CON GLAUCOMA TRATADOS CON LATANOPROST AL 0,005%

    A PHASE 1, OPEN-LABEL STUDY OF LATANOPROST ACID PLASMA CONCENTRATIONS IN PEDIATRIC AND ADULT GLAUCOMA PATIENTS TREATED WITH LATANOPROST 0.005%
    A.4.1Sponsor's protocol code numberA6111139
    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 Yes
    D.2.1.1.1Trade name Xalatan® 0,005 %, colirio en solución
    D.2.1.1.2Name of the Marketing Authorisation holderPfizer, S.A.
    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.3.4Pharmaceutical form Eye drops, solution
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOcular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNlatanoprost
    D.3.9.1CAS number 130209-82-4
    D.3.9.3Other descriptive namelatanoprost 0.005% solución oftálmica
    D.3.10 Strength
    D.3.10.1Concentration unit % percent
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.005
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    GLAUCOMA

    GLAUCOMA
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10018304
    E.1.2Term Glaucoma
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Evaluar las concentraciones plasmáticas sistémicas en equilibrio del ácido de latanoprost tras la administración de latanoprost al 0,005 % (1,5 μg) en pacientes pediátricos y adultos con glaucoma o hipertensión ocular.
    E.2.2Secondary objectives of the trial
    Evaluar la seguridad y la tolerabilidad del latanoprost al 0,005 % en pacientes pediátricos.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • pacientes de ambos sexos y de cualquier edad con glaucoma o con hipertensión ocular, que reciban tratamiento con latanoprost al 0,005 % en un ojo o en los dos durante 2 semanas como mínimo.
    • prueba de un documento de consentimiento informado firmado y fechado en el que se indique que el paciente o sus padres (o tutor legal) han sido informados de todos los aspectos pertinentes del estudio. Será necesario un asentimiento firmado y fechado, si procede, de conformidad con las leyes y regulaciones locales.
    • dispuestos y capaces de cumplir las visitas programadas, el plan de tratamiento y otros procedimientos del estudio (los pacientes y los padres o tutores legales, si se trata de menores).
    • las mujeres en edad fértil (después de la menarquia) deberán dar negativo en una prueba de embarazo en orina realizada en la selección o el día del estudio (antes de la administración).
    E.4Principal exclusion criteria
    • inflamación o infección ocular o antecedentes de inflamación o infección ocular en los 3 meses anteriores a la visita de selección.
    • antecedentes de traumatismo o cirugía ocular en cualquier ojo en los 3 meses anteriores a la visita de selección.
    • antecedentes de hipersensibilidad al latanoprost, al cloruro de benzalconio o a cualquiera de los componentes de Xalatan.
    • uso continuado de lentes de contacto.
    • mujeres embarazadas o lactantes; mujeres en edad fértil y sexualmente activas que no quieran o no puedan utilizar un método anticonceptivo aceptable de los que se recogen en este protocolo desde al menos 14 días antes de la administración de la medicación del estudio hasta 28 días después de la misma.
    • pruebas o antecedentes de enfermedad hematológica, renal, endocrina, pulmonar, digestiva, cardiovascular, hepática, psiquiátrica, neurológica o alérgica (incluidas las alergias a fármacos, pero excluidas las alergias estacionales asintomáticas no tratadas en el momento de la administración) de importancia clínica.
    • antecedentes de enfermedad febril en los 5 días anteriores al comienzo del estudio.
    • cualquier otro trastorno médico o psiquiátrico grave, agudo o crónico, o cualquier alteración analítica que pueda aumentar el riesgo asociado a la participación en el estudio o a la administración del producto en investigación o interferir en la interpretación de los resultados del estudio y que, en opinión del investigador, impida al sujeto participar en este estudio.
    • tratamiento con un fármaco en investigación en los 30 días o 5 semividas anteriores al primer día del estudio.
    • antecedentes de consumo regular de alcohol que supere 14 bebidas/semana en el caso de las mujeres o 21 bebidas/semana en el caso de los varones (1 bebida = 150 ml de vino o 360 ml de cerveza o 45 ml de bebidas fuertes) en los 6 meses anteriores a la selección.
    • uso de tabaco o de productos que contengan nicotina en cantidades que superen el equivalente a 5 cigarrillos al día.
    • donación de aproximadamente 500 ml de sangre en los 56 días anteriores a la administración.
    E.5 End points
    E.5.1Primary end point(s)
    • Concentraciones plasmáticas en equilibrio del ácido de latanoprost.
    • Acontecimientos adversos relacionados con la exposición sistémica al latanoprost.
    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 Yes
    E.6.13.1Other scope of the trial description
    tolerabilidad
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) Yes
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other Yes
    E.7.1.3.1Other trial type description
    Farmacocinética
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised Information not present in EudraCT
    E.8.1.2Open Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    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 Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA8
    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 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
    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 months5
    E.8.9.1In the Member State concerned days28
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months5
    E.8.9.2In all countries concerned by the trial days28
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    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) Yes
    F.1.1.4Infants and toddlers (28 days-23 months) Yes
    F.1.1.5Children (2-11years) Yes
    F.1.1.6Adolescents (12-17 years) Yes
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Para todos los pacientes menores de 12 años se obtendrá el consentimiento de sus representantes legales autorizados (normalmene los padres o tutores)
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state5
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 20
    F.4.2.2In the whole clinical trial 30
    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 Decision2008-06-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-06-05
    P. End of Trial
    P.End of Trial StatusCompleted
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