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    Summary
    EudraCT Number:2011-001986-41
    Sponsor's Protocol Code Number:D3820C00005
    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:2011-07-08
    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 number2011-001986-41
    A.3Full title of the trial
    A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of NKTR-118 in Patients with Non-Cancer-Related Pain and Opioid-Induced Constipation (OIC)
    Estudio aleatorizado, doble ciego y controlado con placebo para evaluar la eficacia y la seguridad de NKTR-118 en pacientes con dolor no oncológico y estreñimiento inducido por opioides (EIO)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Assessment of efficacy and safety in patients with non-cancer-related pain and opioid-induced constipation.
    Evaluación de la eficacia y seguridad en pacientes con dolor no oncológico y estreñimiento inducido por opioides.
    A.3.2Name or abbreviated title of the trial where available
    This study is part of the KODIAC program.
    Este estudio forma parte del programa KODIAC
    A.4.1Sponsor's protocol code numberD3820C00005
    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
    B.5.2Functional name of contact pointInformation Centre
    B.5.3 Address:
    B.5.3.1Street AddressNot Applicable
    B.5.3.2Town/ cityNot Applicable
    B.5.3.3Post codeNot Applicable
    B.5.3.4CountryUnited States
    B.5.4Telephone number001800 236 9933
    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 INNNot applicable
    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 INNNot applicable
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Opioid-induced constipation (OIC)
    Estreñimiento inducido por opioides (EIO)
    E.1.1.1Medical condition in easily understood language
    Constipation after taking Opioid drugs
    Estreñimiento después de tomar medicamentos opioides
    E.1.1.2Therapeutic area Diseases [C] - Nervous System Diseases [C10]
    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 and 25 mg with placebo in the treatment of patients who have OIC.
    Comparar la eficacia de NKTR-118 12,5 y 25 mg con placebo en el tratamiento de los pacientes con estreñimiento inducido por opioides (EIO).
    E.2.2Secondary objectives of the trial
    The secondary objectives are to compare NKTR-118 12.5 and 25 mg with placebo on the daily signs and symptoms associated with OIC (straining, sensation of incomplete evacuation, and stool consistency), symptoms of constipation and quality of life.
    Comparar los efectos de NKTR-118 12,5 y 25 mg con placebo sobre los signos y síntomas diarios asociados a EIO (esfuerzo, sensación de evacuación incompleta y consistencia de las deposiciones), los síntomas de estreñimiento y la calidad de vida.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Provision of written informed consent prior to any study-specific procedures. Men and women who are between the ages of ?18 and <85 years. Self-reported active symptoms of OIC at screening (<3 SBMs/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 SBMs/week on average over the 2-week OIC confirmation period. Receiving a stable maintenance opioid regimen consisting of a total daily dose of 30 mg to 1000 mg of oral morphine, or equianalgesic amount(s) of 1 or more other opiod therapies for a minimum of 4 weeks prior to screening for non-cancer-related pain with no anticipated change in opioid dose requirement over the proposed study period as a result of disease progression. Willingness to stop all laxatives and other bowel regimens including prune juice and herbal products throughout the 2-week OIC confirmation period and the 12-week treatment period, and to use only bisacodyl as rescue medication if a BM has not occurred within at least 72 hours of the last recorded BM.
    Consentimiento informado por escrito antes de realizar ningún procedimiento específico del estudio Varones y mujeres con edades comprendidas entre 18 y < 85 años. Síntomas activos de EIO notificados por el paciente en la selección (< 3 DE/semana y presencia de 1 síntoma notificado de deposiciones duras/grumosas, 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 DE/semana, por término medio, durante el período de confirmación del EIO de dos semanas. En
    tratamiento con un régimen de mantenimiento estable de opioides que consiste en una dosis diaria total de entre 30 y 1.000 mg de morfina oral o una cantidad equianalgésica de uno o más de otros
    tratamientos opioideos durante un mínimo de 4 semanas antes de la selección por dolor no oncológico sin cambios previstos en las necesidades de dosis de opioides durante el período previsto del estudio como consecuencia de progresión de la enfermedad. Disposición a suspender todos los regímenes laxantes e intestinales de otros tipos, incluidos los productos de herbolario y el zumo de ciruela durante el período de confirmación del EIO de dos semanas y el período de tratamiento de 12 semanas y a utilizar únicamente bisacodilo como medicación de rescate si no se ha hecho una deposición, como mínimo, en las 72 horas siguientes a la última deposición registrada.
    E.4Principal exclusion criteria
    Patients receiving Opioid regimen for treatment of pain related to cancer. History of cancer within 5 years from first study visit with the exception of basal cell cancer and squamous cell skin cancer. Medical conditions and treatments associated with diarrhea, intermittent loose stools, or constipation. Other issues to the gastrointestinal tract that could impose a risk to the patient. Pregnancy or lactation.
    Pacientes en tratamiento con un régimen opioideo por dolor oncológico. Antecedentes de cáncer en los 5 años anteriores a la visita de selección a excepción de carcinoma basocelular y espinocelular de piel. Procesos médicos y tratamientos asociados a diarrea, deposiciones sueltas e intermitentes o
    estreñimiento. Otros problemas relacionados con el tubo digestivo que podrían suponer riesgos para el
    paciente. Embarazo o lactancia.
    E.5 End points
    E.5.1Primary end point(s)
    Response (responder/non-responder) to study drug during Weeks 1 to 4, where a responder is defined as having at least 3 Spontaneous Bowel Movements (SBMs)/week, with at least 1 SBM/week increase over baseline, for at least 3 out of the first 4 weeks.
    Respuesta (paciente con respuesta/paciente sin respuesta) al fármaco del estudio durante las semanas 1 a 4, de modo que se define paciente con respuesta como aquel que presente al menos 3 DE/semana, con aumento de al menos 1 DE/semana con respecto al momento basal, durante al menos 3 de las 4 primeras semanas.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Up to 4 weeks
    Hasta 4 semanas
    E.5.2Secondary end point(s)
    Response (responder/non-responder) to study drug in the LIR subgroup during Weeks 1 to 4, where a responder is defined as having at least 3 SBMs/week, with at least 1 SBM/week increase over baseline, for at least 3 out of the first 4 weeks.

    Response (responder/non-responder) to study drug over the entire 12 week treatment period, where a responder is defined as having at least 3 SBMs/week, with at least 1 SBM/week increase over baseline, for at least 75% of the weeks.

    Regularity during the first 4 weeks of treatment, where regularity is measured as the mean number of days per week with at least 1 SBM during Weeks 1 to 4.
    Respuesta (paciente con respuesta/paciente sin respuesta) al fármaco del estudio en el subgrupo RIL durante las semanas 1 a 4, de modo que se define paciente con respuesta como aquel que presente al menos 3 DE/semana, con aumento de al menos 1 DE/semana con respecto al momento basal, durante al menos 3 de las 4 primeras semanas.

    Respuesta (paciente con respuesta/paciente sin respuesta) al fármaco del estudio durante todo el período de tratamiento de 12 semanas, de modo que se define paciente con respuesta como aquel que presente al menos 3 DE/semana, con aumento de al menos 1 DE/semana con respecto al momento basal, durante al menos el 75 % de las semanas.

    Regularidad durante las 4 primeras semanas de tratamiento, de modo que la regularidad se mide como el número medio de días por semana con al menos 1 DE durante las semanas 1 a 4.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Up to 4 weeks
    12 weeks
    Up to 4 weeks
    Hasta 4 semanas
    12 semanas
    Hasta 4 semanas
    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 concerned13
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA45
    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
    Belgium
    Croatia
    Hungary
    Spain
    Sweden
    United Kingdom
    United States
    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
    LVLS
    Última visita, 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 months6
    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 months6
    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: 530
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 80
    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 No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state22
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 89
    F.4.2.2In the whole clinical trial 630
    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
    Cuidado estándar
    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 Decision2011-09-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-08-08
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2012-09-20
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