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    Summary
    EudraCT Number:2013-003935-32
    Sponsor's Protocol Code Number:D3820C00016
    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:2014-02-07
    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 number2013-003935-32
    A.3Full title of the trial
    A Phase I, Open-Label, Multicentre Study to Assess the Pharmacokinetics and Safety of Naloxegol in Paediatric Patients Ages ? 6 Months to < 18 Years Receiving Treatment with Opioids
    Ensayo fase I, abierto, multicéntrico, para evaluar la farmacocinética y la seguridad de naloxegol en pacientes pediátricos de ? 6 meses a < 18 años que reciben tratamiento con opioides.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Open-label study to assess the PK and safety of naloxegol in paediatric patients receiving opioids
    Ensayo abierto, para evaluar la farmacocinética y la seguridad de naloxegol en pacientes pediátricos que reciben opioides.
    A.3.2Name or abbreviated title of the trial where available
    Kodiac-16
    Kodiac-16
    A.4.1Sponsor's protocol code numberD3820C00016
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/183/2012
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorAstraZeneca AB
    B.1.3.4CountrySweden
    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 supportAstraZeneca AB
    B.4.2CountrySweden
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAstraZeneca Farmaceutica Spain, S.A.
    B.5.2Functional name of contact pointUnidad de Investigación Clinica
    B.5.3 Address:
    B.5.3.1Street AddressC/ Serrano Galvache, 56, Parque Norte, Edificio Roble
    B.5.3.2Town/ cityMadrid
    B.5.3.3Post code28033
    B.5.3.4CountrySpain
    B.5.4Telephone number0034900200444
    B.5.6E-mailinformacionEECC-Spain@astrazeneca.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 namenaloxegol film-coated tablet 25 mg (as naloxegol oxalate 28.5 mg)
    D.3.2Product code n/a
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation Yes
    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 INNnaloxegol
    D.3.9.1CAS number 1354744-91-4
    D.3.9.2Current sponsor codenaloxegol oxalate
    D.3.9.3Other descriptive nameNALOXEGOL
    D.3.9.4EV Substance CodeSUB126723
    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) 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 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 namenaloxegol film-coated tablet 5 mg (as naloxegol oxalate 5.7 mg)
    D.3.2Product code n/a
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation Yes
    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 INNnaloxegol
    D.3.9.1CAS number 1354744-91-4
    D.3.9.2Current sponsor codenaloxegol oxalate
    D.3.9.3Other descriptive nameNALOXEGOL
    D.3.9.4EV Substance CodeSUB126723
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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: 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 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 namenaloxegol film-coated tablet 12.5 mg (as naloxegol oxalate 14.2 mg)
    D.3.2Product code n/a
    D.3.4Pharmaceutical form Film-coated 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 INNnaloxegol
    D.3.9.1CAS number 1354744-91-4
    D.3.9.2Current sponsor codenaloxegol oxalate
    D.3.9.3Other descriptive nameNALOXEGOL
    D.3.9.4EV Substance CodeSUB126723
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number12.5
    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) 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: 4
    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 namenaloxegol oral solution 0.8 mg/ml (as naloxegol oxalate 0.9 mg/ml)
    D.3.2Product code n/a
    D.3.4Pharmaceutical form Oral solution
    D.3.4.1Specific paediatric formulation Yes
    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 INNnaloxegol
    D.3.9.1CAS number 1354744-91-4
    D.3.9.2Current sponsor codenaloxegol oxalate
    D.3.9.3Other descriptive nameNALOXEGOL
    D.3.9.4EV Substance CodeSUB126723
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.8
    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: 5
    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 namenaloxegol oral solution 2.5 mg/ml (as naloxegol oxalate 2.8 mg/ml)
    D.3.2Product code n/a
    D.3.4Pharmaceutical form Oral solution
    D.3.4.1Specific paediatric formulation Yes
    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 INNnaloxegol
    D.3.9.1CAS number 1354744-91-4
    D.3.9.2Current sponsor codenaloxegol oxalate
    D.3.9.3Other descriptive nameNALOXEGOL
    D.3.9.4EV Substance CodeSUB126723
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    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) 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
    Opioid-induced constipation
    Estreñimiento inducido por opioides.
    E.1.1.1Medical condition in easily understood language
    Treatment of constipation after taking opioid drugs
    Tratamiento de estreñimiento causado por opioides
    E.1.1.2Therapeutic area Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.1
    E.1.2Level LLT
    E.1.2Classification code 10071128
    E.1.2Term Opioid induced constipation
    E.1.2System Organ Class 100000004856
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To characterize the pharmacokinetics (PK) of naloxegol after single oral dose and through population PK in paediatric patients with opioid induced constipation (OIC).
    Definir la farmacocinética (FC) de naloxegol tras una dosis oral única y mediante la FC poblacional en pacientes pediátricos con estreñimiento inducido por opioides (EIO).
    E.2.2Secondary objectives of the trial
    · To characterize the PK of naloxegol after multiple, once-daily, oral dosing in paediatric OIC patients who continue participation beyond Day 1. A minimum of 3 days of dosing is required for multiple-dose PK analysis.
    · To evaluate the acceptability of the study medication in paediatric OIC patients through assessment of: 1) palatability of liquid formulation and, 2) the ability of the patient to swallow the tablet.
    ? Definir la FC de naloxegol tras la administración una vez al día de múltiples dosis orales en pacientes pediátricos con EIO que siguen participando después del día 1. Se necesita un mínimo de 3 días de administración para el análisis de la FC tras dosis repetidas.
    ? Evaluar el grado de aceptacion de la medicación del estudio en pacientes pediátricos con EIO mediante: 1) palatabilidad de la formulación líquida y 2) capacidad del paciente de tragar el comprimido.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Patients between the ages of ? 6 months and < 18 years.
    - Patients with malignant or non-malignant pain who are receiving (or are about to receive) acute or chronic treatment with opioids.
    - In the investigator?s judgment, patients must be either newly diagnosed with constipation or patients must have a history of constipation treated with laxatives or are expected to develop constipation after initiation of opioid treatment.
    - Female patients of childbearing potential must have a negative urine pregnancy test at screening. Females of childbearing potential must either not be sexually active or be using an adequate birth control method throughout the duration of the study.
    - Pacientes de ? 6 meses a < 18 años.
    - Pacientes con dolor, neoplásico o no, que estén recibiendo (o estén a punto de recibir) un tratamiento de corta o larga duración con opioides.
    - En opinión del investigador, los pacientes tienen que tener un diagnóstico reciente de estreñimiento o antecedentes de estreñimiento tratado con laxantes o se prevé que padecerán estreñimiento tras el inicio del tratamiento con opioides.
    - Las mujeres en edad fértil deben tener un resultado negativo en una prueba de embarazo en orina realizada en la selección. Las mujeres potencialmente fértiles no deben ser sexualmente activas o deben usar un método anticonceptivo adecuado durante todo el ensayo.
    E.4Principal exclusion criteria
    1. Involvement of a parent or guardian in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site).
    2. Previous enrolment in the present study with intake of naloxegol investigational product.
    3. Current acute or chronic use of methadone. For patients 6-12 months old, history of major corrective or reconstructive gastrointestinal surgery (except pyloric stenosis) in the last 6 months or possible need for corrective or reconstructive gastrointestinal surgery in the next month, or history of post-surgical ileus. For patients over 1 year of age, history of previous gastrointestinal surgery in the last 6 months (does not include placement of enteral tubes or liver biopsies).
    4. History of an intra-abdominal or peritoneal neoplasm or an ongoing GI-related issue (e.g., inflammatory bowel disease, connective tissue disorders like Ehler Danlos, dermatomyositis, scleroderma) which, in the opinion of the investigator, may be contributing to constipation as a result of mechanical obstruction or may place the patient at increased risk for intestinal perforation by impairing the local or global structural integrity of the GI tract.
    5. Signs or symptoms of GI obstruction including faecal impaction requiring medical intervention. History of GI obstructive conditions (e.g. Hirschsprung?s disease, malrotation, volvulus, pseudo-obstruction syndromes).
    6. Currently active medical conditions or ongoing treatments (e.g. irinotecan) that may result in diarrhoea or intermittent loose stools during the screening or treatment period.
    7. Need for mechanical ventilation, haemodynamic instability or other significant cardiorespiratory dysfunction.
    8. Evidence of known widespread cancer metastases in the CNS.
    9. Radiotherapy between the diaphragm and the pelvis in the 4 weeks prior to screening or planned to be initiated during the treatment period.
    10.Any of the following findings and/or conditions:
    (a) For patients 6 -12 months old, any elevation of serum direct or indirect bilirubin and LFTs that have not undergone a medical work up. For patients over 1 year old, serum ALT or AST >2.5 x upper limit of normal (ULN) and/or serum bilirubin >1.2 x ULN (unless known to be due to Gilbert?s syndrome).
    (b)Creatinine clearance less than 90 ml/min/1.73 m2 (using the Shwartz formula*).
    (c) Absolute neutrophil count (ANC) <0.5 x 10^9/L; haemoglobin <9 g/dL or, platelet count < 50,000/uL at the time of the first dose of naloxegol.
    11. History (within past 3 months) of prolonged (> 10 days) neutropenia or thrombocytopenia with clinical sequelae.
    12. Treatment with another experimental medication for which there is no current labelled therapy (adult or paediatric), currently or within the last 30 days.
    13. Patients with cancer currently receiving the first cycle of chemotherapy, or due to receive a chemotherapeutic agent for the first time.
    14. Life expectancy of < 3 months.
    1. Implicación del progenitor o tutor en la planificación y/o realización del ensayo (aplicable al personal de AstraZeneca y/o al personal del centro del ensayo).
    2. Inclusión previa en este ensayo habiendo tomado el producto en investigación naloxegol.
    3. Uso actual de metadona de corta o larga duración. En los pacientes de 6 a 12 meses de edad, antecedentes de cirugía digestiva correctora o reparadora (excepto estenosis pilórica) en los 6 últimos meses o posible necesidad de cirugía digestiva correctora o reparadora en el mes siguiente o antecedentes de íleo posquirúrgico. En los pacientes mayores de 1 año, antecedentes de cirugía digestiva previa en los 6 últimos meses (no incluye la colocación de sondas intestinales o biopsias hepáticas).
    4. Antecedentes de una neoplasia intraabdominal o peritoneal o presencia actual de un problema relacionado con el aparato digestivo (p. ej., enfermedad inflamatoria intestinal, trastornos del tejido conjuntivo como el síndrome de Ehler Danlos, dermatomiositis, escleroderma) que, en la opinión del investigador, pudieran contribuir al estreñimiento como consecuencia de obstrucción mecánica o pudieran suponer para el paciente mayor riesgo de perforación intestinal al afectar a la integridad estructural local o general del tubo digestivo.
    5. Signos y síntomas de obstrucción del tubo digestivo, incluida la impactación fecal que precisa intervención médica. Antecedentes de trastornos GI obstructivos (p. ej., enfermedad de Hirschsprung, malrotación, vólvulos, síndromes pseudoobstructivos).
    6. Enfermedades médicas actualmente activas o tratamientos en curso (p. ej., irinotecán) que puedan producir diarrea o heces blandas intermitentes durante la selección o el período de tratamiento.
    7. Necesidad de respiración mecánica, inestabilidad hemodinámica u otra disfunción cardiorrespiratoria importante.
    8. Constancia de metástasis generalizadas en el SNC.
    9. Radioterapia entre el diafragma y la pelvis en las 4 semanas previas a la selección o está previsto iniciarla durante el periodo de tratamiento.
    10. Cualquiera de los siguientes hallazgos o trastornos:
    (a) En pacientes de 6 a 12 meses de edad, cualquier elevación de la bilirrubina directa o indirecta en suero y de las pruebas de función hepática que no hayan sido objeto un estudio diagnóstico. En pacientes de más de 1 año, ALT o AST séricas > 2,5 veces el límite superior de la normalidad (LSN) y/o bilirrubina sérica 1,2 veces el LSN (salvo que se sepa que es debida a un síndrome de Gilbert).
    (b) Aclaramiento de creatinina inferior a 90 ml/min/1,73 m2 (mediante la fórmula de Shwartz*).
    (c) Recuento absoluto de neutrófilos (RAN) <0,5 x 10^9/l; hemoglobina <9 g/dl o recuento de plaquetas < 50.000/µl en el momento de administrar la primera dosis de naloxegol.
    11. Antecedentes (en los 3 meses anteriores) de neutropenia prolongada (> 10 días) o trombocitopenia con secuelas clínicas.
    12. Tratamiento actual o en los 30 días previos con otra medicación experimental para la que no exista en la actualidad un tratamiento autorizado (en adultos o pediátrico).
    13. Pacientes con cáncer que han recibido el primer ciclo de quimioterapia o van a recibir un antineoplásico por primera vez.
    14. Esperanza de vida ? 3 meses
    E.5 End points
    E.5.1Primary end point(s)
    Standard non-compartmental analysis approach: area under the plasma concentration-time curve from zero extrapolated to infinity (AUC), area under the plasma concentration-time curve from zero to the last quantifiable concentration (AUC(0-t)), maximum plasma concentration (Cmax), terminal half-life (t1/2?z), time to maximum plasma concentration (tmax), and mean residence time (MRT), oral clearance (CL/F), volume of distribution during the terminal phase (Vz), and apparent volume of distribution at steady state (Vss/F).
    Population pharmacokinetic modelling approach: population estimated structural PK parameters and influence of potential covariates
    Método de análisis estándar no compartimental: área bajo la curva de concentración plasmática-tiempo, extrapolada entre cero e infinito (AUC), área bajo la curva de concentración plasmática-tiempo desde cero hasta la última concentración cuantificable (AUC(0-t)), concentración plasmática máxima (Cmax), semivida terminal (t1/2?z), tiempo hasta la concentración plasmática máxima (tmax), tiempo medio de permanencia (TMP), aclaramiento oral (CL/F), volumen de distribución durante la fase terminal (Vz), y volumen de distribución aparente en estado de equilibrio (Vss/F).
    Método de creación del modelo farmacocinético poblacional: cálculo de los parámetros farmacocinéticos estructurales poblacionales (es decir, CL/F, V/F y otros parámetros si procede) e influencia de posibles covariables
    E.5.1.1Timepoint(s) of evaluation of this end point
    24 hour PK blood sampling after first dose and on day 7
    Determinacion de curva PK en las primeras 24 horas tras la 1ª dosis y en el dia 7.
    E.5.2Secondary end point(s)
    Other additional multiple dose PK parameters, e.g., RAC(AUC) and Rac(Cmax).
    Determinacion de parametros de farmacocinetica tras dosis múltiple.
    E.5.2.1Timepoint(s) of evaluation of this end point
    24 hour PK blood sampling after first dose and on day 7
    Determinacion de curva PK en las primeras 24 horas tras la 1ª dosis y en el dia 7.
    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 No
    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) 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
    paediatric study
    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 Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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 No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial3
    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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA10
    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
    Canada
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months0
    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 Yes
    F.1.1Number of subjects for this age range: 48
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) Yes
    F.1.1.4.1Number of subjects for this age range: 8
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 24
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 16
    F.1.2Adults (18-64 years) No
    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 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
    Trial is conducted in paediatric patients. Signed informed consent will be obtained from the parent/both parents/legal guardian (according to local regulations) and assent from the child/adolescent (where required from local regulations)
    Ensayo se lleva a cabo en pacientes pediatricos. El Asentimiento/ Consentimiento informado tiene que ser firmado por niños/adolescentes; padres o tutores conforme a la normativa local.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state11
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 40
    F.4.2.2In the whole clinical trial 48
    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)
    Normal standard of care will be applied
    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 Decision2014-05-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-03-07
    P. End of Trial
    P.End of Trial StatusOngoing
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