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    Summary
    EudraCT Number:2011-001985-16
    Sponsor's Protocol Code Number:D3820C00006
    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:2011-08-09
    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 number2011-001985-16
    A.3Full title of the trial
    A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of NKTR-118 in Relieving Opioid-Induced Constipation (OIC) in Patients with Cancer-Related Pain.
    Estudio aleatorizado, doble ciego y controlado con placebo para
    evaluar la eficacia y la seguridad de NKTR-118 como alivio del
    estreñimiento inducido por opioides (EIO) en pacientes con dolor
    oncológico
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Assessment of efficacy and safety in relieving opioid-induced constipation in patients with cancer-related pain.
    Evaluación de la eficacia y la seguridad como alivio del
    estreñimiento inducido por opioides en pacientes con dolor
    oncológico.
    A.3.2Name or abbreviated title of the trial where available
    This study is part of the KODIAC program.
    Este estudio es parte del programa KODIAC.
    A.4.1Sponsor's protocol code numberD3820C00006
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01323790
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    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 LP
    B.5.2Functional name of contact pointInformation Center
    B.5.3 Address:
    B.5.3.1Street AddressNA
    B.5.3.2Town/ cityNA
    B.5.3.3Post codeNA
    B.5.3.4CountryUnited States
    B.5.6E-mailinformation.center@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 nameNKTR-118
    D.3.2Product code NKTR-118
    D.3.4Pharmaceutical form 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 INNn/a
    D.3.9.1CAS number 854601-70-0
    D.3.9.2Current sponsor codeNKTR-118
    D.3.9.3Other descriptive nameAZ13337019
    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: 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 nameNKTR-118
    D.3.2Product code NKTR-118
    D.3.4Pharmaceutical form 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 INNn/a
    D.3.9.1CAS number 854601-70-0
    D.3.9.2Current sponsor codeNKTR-118
    D.3.9.3Other descriptive nameAZ13337019
    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.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCoated 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 placeboCoated tablet
    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
    Scientific Terminology Opioid-Induced Constipation (OIC)
    Laymen Terminology Constipation after taking Opioid drugs
    Terminología Científica Estreñimiento inducido por opioides (EIO)
    Terminología Laica Estreñimiento después de tomar medicamentos opioides
    E.1.1.1Medical condition in easily understood language
    Cancer-Related Pain, Opioid-Induced Constipation
    Dolor oncológico, Estreñimiento inducido 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 14.0
    E.1.2Level PT
    E.1.2Classification code 10010774
    E.1.2Term Constipation
    E.1.2System Organ Class 10017947 - Gastrointestinal disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of this study is to compare the efficacy of NKTR-118 12.5 mg and 25 mg with placebo in the treatment of opioid-induced constipation (OIC) in pain related to malignancy.
    El objetivo principal de este estudio es comparar la eficacia de NKTR-118 12,5 mg y 25 mg con respecto a un placebo para el tratamiento del estreñimiento inducido por opioides (EIO) en el dolor relacionado con el cáncer.
    E.2.2Secondary objectives of the trial
    The secondary objective is to compare NKTR-118 12.5 mg and 25 mg with placebo in the daily signs and symptoms associated with OIC (degree of straining, sensation of incomplete evacuation, and stool consistency), symptoms of constipation, and overall quality of life.
    El objetivo secundario es comparar los efectos de NKTR-118 12,5 mg y 25 mg con respecto a un placebo sobre los signos y síntomas diarios asociados al EIO (grado de esfuerzo, sensación de evacuación incompleta y consistencia de las heces), los síntomas del estreñimiento y la calidad de vida general
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Pharmacogenetics Research version 1.0 24March2011

    AstraZeneca intends to perform genetic research in the NKTR-118 clinical development
    programme to explore how genetic variations may affect the clinical parameters associated
    with NKTR-118

    GENETIC RESEARCH OBJECTIVES:
    The objective of this research is to collect and store DNA for future exploratory research into
    genes/genetic variation that may influence response (ie, distribution, safety, tolerability and
    efficacy) and/or susceptibility to Opioid-Induced Constipation (OIC) and/or agents used in
    combination and/or as comparators.
    INVESTIGACIÓN GENÉTICA
    version 1.0 24Marzo2011
    AstraZeneca pretende realizar una investigación genética en el programa de desarrollo clínico de NKTR-118 para estudiar el modo en que las variaciones genéticas pueden afectar a los parámetros clínicos asociados a NKTR-118.

    OBJETIVOS DE LA INVESTIGACIÓN GENÉTICA
    El objetivo de esta investigación consiste en recoger y conservar ADN para futuras investigaciones exploratorias sobre los genes y la variación genética que podrían influir en la respuesta (es decir, distribución, seguridad, tolerabilidad y eficacia) a NKTR-118 o a los fármacos utilizados en combinación o como productos de comparación o en la predisposición al EIO.
    E.3Principal inclusion criteria
    1. Provision of written informed consent prior to any study-specific procedures.

    2. Men and women aged 18 or older.

    3. Histologically or cytologically confirmed neoplasm causing pain and requiring management with opioids.

    4. Self-reported active symptoms of OIC at screening (<3 RFBMs/week and experiencing >1 reported symptom of hard/lumpy stools, straining, or sensation of incomplete evacuation/anorectal obstruction in at least 25% of BMs over the previous 4 weeks); and Documented confirmed OIC (<3 RFBMs/week on average aver the 2-week OIC confirmation period.

    5. Receiving a stable maintenance opioid regimen consisting of a total daily dose of >30 mg of oral morphine, or equianalgesic amount(s) of 1 or more opioid therapies for a minimum of 4 weeks prior to screening for cancer-related pain with no anticipated change in opioid dose requirement over the proposed study period as a result of disease progression.
    1. Entrega de un consentimiento informado por escrito antes del inicio de cualquiera de los procedimientos relacionados con el estudio.
    2. Varones y mujeres de 18 años o más.
    3. Neoplasia confirmada por histología o citología que cause dolor y precise tratamiento con opioides.

    4. Síntomas activos de EIO notificados por el paciente en la selección (< 3 DSMR/semana y presencia de ? 1 síntoma notificado de deposiciones duras/en bolas, esfuerzo o sensación de evacuación incompleta/obstrucción anorrectal en al menos el 25 % de las deposiciones durante las 4 semanas previas) y EIO confirmado documentado (<3 DSMR/semana por término medio durante el periodo de confirmación del EIO de dos semanas).

    5. En tratamiento con un régimen de mantenimiento estable de opioides que consista en una dosis diaria total ? 30 mg de morfina oral o cantidad equianalgésica de uno o más de otros tratamientos opioideos (véase el apéndice H) durante un mínimo de 4 semanas antes de la selección por dolor oncológico, sin que se anticipe una variación de las necesidades de dosis de opioides como consecuencia de la progresión de la enfermedad durante el periodo previsto de tratamiento de 4 semanas.
    E.4Principal exclusion criteria
    1. Patients receiving Opioid regimen for treatment of pain other than related to cancer.

    2. Any condition that may have affected the permeability of the blood-brain barrier, eg, known brain metastases, meningeal metastases, brain injury, multiple sclerosis, recent brain injury, uncontrolled epilepsy.
    3. Patients with cancer-related pain due to ovarian cancer, leukaemia, or lymphoma are excluded. Patients with multiple myeloma will be allowed.
    4. Patients requiring radiation therapy between the diaphragm and pelvis 4 weeks prior to Visit 1 (screening) and/or during the study are excluded. Any patients with suspected clinically relevant radiation-induced injury of small or large intestine are excluded.
    5. Pregnancy or lactation.
    1. Pacientes que reciban un régimen opioideo para el tratamiento del dolor no oncológico.
    2. Cualquier trastorno que pueda haber afectado a la permeabilidad de la barrera hematoencefálica, por ejemplo, metástasis cerebrales conocidas, metástasis meníngeas, lesión cerebral, esclerosis múltiple, lesión cerebral reciente, epilepsia no controlada.
    3. Se excluirá a los pacientes con dolor oncológico por cáncer de ovario, leucemia o linfoma. Podrán participar los pacientes con mieloma múltiple.

    4. Se excluirá a los pacientes que necesiten radioterapia entre el diafragma y pelvis 4 semanas antes de la visita 1 (selección) y/o durante el estudio. Quedan excluidos los pacientes con sospecha de lesión del intestino delgado o grueso inducida por la radiación con importancia clínica.
    5. Embarazo o lactancia
    E.5 End points
    E.5.1Primary end point(s)
    Response (responder/non-responder) to study drug, where a responder is defined as having at least 3 Rescue-free bowel movements (RFBMs) per week during the 4-week treatment period, with at least 1 RFBM per week increase over baseline for at least 3 out of 4 weeks.
    Respuesta (paciente con respuesta/paciente sin respuesta) al fármaco del estudio durante el periodo de tratamiento de 4 semanas, definiéndose paciente con respuesta como aquel que presenta al menos 3 DSMR/semana, con aumento de al menos 1 DSMR/semana con respecto al momento basal, durante al menos 3 de las 4 semanas
    E.5.1.1Timepoint(s) of evaluation of this end point
    Will be collected daily through the 4-week treatment period.
    Se recogerán todos los días durante el período de tratamiento de 4 semanas
    E.5.2Secondary end point(s)
    Change from baseline in RFBMs/week during the 4-week treatment period.

    Regularity during the 4-week treatment period, where regularity is measured as the mean number of days per week with at least 1 RFBM.

    Time (in hours) to first post-dose RFBM.

    Change from baseline in the degree of straining associated with RFBMs during the 4-week treatment period.

    Change from baseline in stool consistency (BSS) during the 4-week treatment period.

    Percentage of days with complete evacuation during the 4-week treatment period.

    Change from baseline in Patient Assessment of Constipation Symptoms (PAC-SYM) and Patient Assessment of Constipation Quality of Life (PAC-QOL) total score and each domain score for Weeks 2 and 4.
    Variación con respecto al valor basal durante el periodo de tratamiento de 4 semanas.

    Regularidad durante el periodo de tratamiento de 4 semanas, de forma que la regularidad se mide como el número medio de días por semana con al menos 1 DSMR

    Tiempo (horas) hasta la primera DSMR

    Variación con respecto al momento basal del grado de esfuerzo durante el periodo de tratamiento de 4 semanas.

    Variación con respecto al momento basal de la consistencia media de las deposiciones (BSS) durante el periodo de tratamiento de 4 semanas.

    Porcentaje de días con evacuación completa durante el periodo de tratamiento de 4 semanas.

    Variación de la puntuación total y la puntuación de cada dominio de la escala PAC-SYM, y de la puntuación total y la puntuación de cada dominio de la escala PAC-QOL, entre el momento basal y las semanas 2 y 4.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Will be collected daily through the 4-week treatment period.

    Will be evaluated at Visits 3, 5 and 6.
    Se recogerán todos los días durante el período de tratamiento de 4 semanas

    Serán evaluados en las visitas 3, 5 y 6.
    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 Yes
    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 Yes
    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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    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.8.2.4Number 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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA65
    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
    Australia
    Belgium
    Bulgaria
    Croatia
    Czech Republic
    Germany
    Hungary
    Poland
    Romania
    Slovakia
    South Africa
    Spain
    United Kingdom
    United States
    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
    last visit of the last subject
    Última visita del último paciente
    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 months2
    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 months2
    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 No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 60
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 50
    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 state6
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 110
    F.4.2.2In the whole clinical trial 336
    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)
    Standard of care
    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 Decision2011-11-10
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-10-13
    P. End of Trial
    P.End of Trial StatusOngoing
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