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    Summary
    EudraCT Number:2013-002819-10
    Sponsor's Protocol Code Number:M13-621
    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:2013-11-12
    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 number2013-002819-10
    A.3Full title of the trial
    A Double-blind, Randomized, Multicenter, Cross-over Study to Compare the Effect of Creon N and Creon® on Fat Digestion in Subjects ? 12 years of Age with Pancreatic Exocrine Insufficiency Due to Cystic Fibrosis
    Estudio doble ciego, aleatorizado, multicéntrico y cruzado para comparar el efecto de Kreon N y Kreon® sobre la digestión de grasas en sujetos de 12 años o más edad con insuficiencia pancreática exocrina debida a fibrosis quística.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Double-blind, Randomized, Multicenter, Cross-over Study to Compare the Effect of Creon N and Creon® on Fat Digestion in Subjects ? 12 years of Age with Pancreatic Exocrine Insufficiency Due to Cystic Fibrosis
    Estudio doble ciego, aleatorizado, multicéntrico y cruzado para comparar el efecto de Kreon N y Kreon® sobre la digestión de grasas en sujetos de 12 años o más edad con insuficiencia pancreática exocrina debida a fibrosis quística.
    A.4.1Sponsor's protocol code numberM13-621
    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 SponsorAbbott Laboratories GmbH
    B.1.3.4CountryGermany
    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 supportAbbott Laboratories GmbH
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAbbott Laboratories GmbH
    B.5.2Functional name of contact pointSenior Clinical Trial Manager
    B.5.3 Address:
    B.5.3.1Street AddressFreundallee 9A
    B.5.3.2Town/ cityHannover
    B.5.3.3Post code30173
    B.5.3.4CountryGermany
    B.5.4Telephone number+49511 6750 2733
    B.5.5Fax number+49511 6750 2464
    B.5.6E-mailgregor.eibes@abbott.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 nameKREON N 25000
    D.3.4Pharmaceutical form Capsule, hard
    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 8049-47-6
    D.3.9.2Current sponsor codeKREON N
    D.3.9.3Other descriptive namePANCREATIN
    D.3.9.4EV Substance CodeSUB12545MIG
    D.3.10 Strength
    D.3.10.1Concentration unit IU/kg international unit(s)/kilogram
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25000
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 RoleComparator
    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 Kreon 25000
    D.2.1.1.2Name of the Marketing Authorisation holderAbbott Laboratories GmbH
    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 Capsule, hard
    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 assigned
    D.3.9.1CAS number 8049-47-6
    D.3.9.3Other descriptive namePANCREATINA
    D.3.9.4EV Substance CodeSUB12545MIG
    D.3.10 Strength
    D.3.10.1Concentration unit IU international unit(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25000
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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
    Pancreatic exocrine Insufficiency due to Cystic Fibrosis
    Insuficiencia pancreática exocrina debida a Fibrosis Quística
    E.1.1.1Medical condition in easily understood language
    maldigestion of diatery macronutrients (pancreas not producing enough enzymes for digestion of fat, sugars and proteins) in Cystic Fibrosis
    Mala digestión de macronutrientes de la dieta (el páncreas no produce suficientes encimas para la digestión de la grasa, azúcares y proteínas) in Fibrosis Quística
    E.1.1.2Therapeutic area Diseases [C] - Respiratory Tract Diseases [C08]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the therapeutic equivalence of Creon N 25000 with Creon® 25000 on coefficient of fat absorption (CFA) in adolescent and adult subjects with pancreatic exocrine insufficiency (PEI) due to cystic fibrosis (CF).
    Evaluar la equivalencia terapéutica de Kreon N 25000 con Kreon® 25000 sobre el coeficiente de absorción de grasas (CAG) en sujetos adolescentes y adultos con insuficiencia pancreática exocrina (IPE) debida a fibrosis quística (FQ).
    E.2.2Secondary objectives of the trial
    To investigate the effect of Creon N 25000 and Creon® 25000 on coefficient of nitrogen absorption (CNA),on stool fat and clinical symptomatology (stool frequency, stool consistency, abdominal pain, flatulence).
    Safety Objectives:
    To evaluate the short-term safety of Creon N 25000 and Creon® 25000, including vital signs, body weight, physical examination, safety laboratory values, and adverse events (AEs).
    Estudiar el efecto de Kreon N 25000 y Kreon® 25000 sobre el coeficiente de absorción de nitrógeno (CAN), sobre la grasa fecal y la sintomatología clínica (frecuencia de las deposiciones, consistencia de las heces, dolor abdominal, flatulencia).
    Objetivos de seguridad
    Evaluar la seguridad a corto plazo de Kreon N 25000 y Kreon® 25000, incluyendo constantes vitales, peso corporal, exploración física, valores analíticos de seguridad y acontecimientos adversos (AA).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Signed informed consent given by the subject, or the parents, or a legally acceptable representative. If required by the Institutional Review Board/Ethics Committee (IRB/IEC), assent will be given by the subject
    2. Age ? 12 years
    3. Subjects who are able to swallow capsules with each meal and snacks
    4. Diagnosis of CF confirmed by two positive chloride sweat tests or gene analysis
    5. Diagnosis of pancreatic exocrine insufficiency proven by:
    a. CFA < 70% without supplementation
    b. or
    Human fecal elastase < 50 µg/g stool
    6. Currently receiving treatment with a commercially available pancreatic enzyme product and on a continuous dose of this product for more than 3 months
    7. Clinically stable condition without evidence of acute respiratory disease within 1 month of enrollment
    8. Stable body weight defined as no more than a 5% decline within 3 months of enrolment
    9. Females of child-bearing potential should agree to continue using a medically acceptable method of birth control throughout the study and for 30 days immediately after the last dose of study drug. Medically acceptable methods of birth control include bilateral tubal ligation or the use of either a contraceptive implant, a contraceptive injection (Depo-Provera?), an intrauterine device, or an oral contraceptive taken within the past 3 months where the subject agrees to continue using during the study or to adopt another birth control method, or a double-barrier method which consists of a combination of any two of the following: diaphragm, cervical cap, condom, or spermicide.
    1. Consentimiento informado firmado por el sujeto, los progenitores o un representante legal. Si el Comité Ético de Investigación Clínica/Comité de Revisión Institucional (CEIC/IRB) lo requiere, se obtendrá el asentimiento del sujeto.
    2. Edad ? 12 años.
    3. Sujetos que sean capaces de tragar las cápsulas con cada comida o tentempié.
    4. Diagnóstico de FQ confirmado por dos pruebas positivas de cloruro en sudor o análisis génico.
    5. Diagnóstico de insuficiencia pancreática exocrina demostrado por:
    a. CAG < 70% sin suplementación
    b. o
    Elastasa fecal humana < 50 µg/g de heces.
    6. Estar recibiendo actualmente tratamiento con un producto de enzimas pancreáticas disponible en el mercado y a una dosis continua de este producto durante más de 3 meses.
    7. Enfermedad clínicamente estable sin indicios de enfermedad respiratoria aguda en el mes previo a la inclusión en el estudio.
    8. Peso corporal estable definido como una reducción no superior al 5% en los 3 meses previos a la inclusión en el estudio.
    9. Las mujeres en edad fértil deben estar de acuerdo en continuar usando un método anticonceptivo médicamente aceptable durante todo el estudio y durante los 30 días inmediatamente posteriores a la última dosis del fármaco del estudio. Los métodos anticonceptivos médicamente aceptables son: ligadura de trompas bilateral o el uso de un implante anticonceptivo, inyección anticonceptiva (Depo-Provera?), dispositivo intrauterino o anticonceptivo oral tomado durante los últimos 3 meses y que la paciente acepte continuar tomando durante el estudio o adoptar otro método anticonceptivo, o un método de doble barrera que consista en una combinación de cualquiera de los siguientes métodos: diafragma, capuchón cervical, preservativo o espermicida.
    E.4Principal exclusion criteria
    1. Evidence of cardiovascular, respiratory, urogenital, gastrointestinal/hepatic (except underlying disease), hematologic/immunologic, head, ears, eyes, nose, throat, dermatologic/connective tissue, musculoskeletal, metabolic/nutritional (except underlying disease), endocrine (except diabetes mellitus), neurologic/psychiatric, allergy, recent major surgery, or other relevant diseases as revealed by history, physical examination and/or laboratory assessments, which could limit participation in or completion of the study
    2. History of acute abdomen
    3. History of fibrosing colonopathy
    4. History of distal intestinal obstruction syndrome (DIOS) within 6 months prior to enrollment
    5. Solid organ transplant or surgery affecting the large bowel other than appendectomy
    6. Small bowel surgery that significantly affected absorptive capacity (e.g. gastrectomy or pancreatectomy)
    7. Pregnancy or lactation
    8. Any type of malignancy involving the digestive tract in the last 5 years
    9. Celiac disease or Crohn?s disease
    10. Known allergy to pancreatin or inactive ingredients (excipients) of pancreatin capsules
    11. Suspected non-compliance or non-cooperation
    12. Intake of experimental drugs within 30 days prior to study start
    13. Mental disability or any other lack of fitness, in the Investigator's opinion, to preclude subject?s participation in or ability to complete the study
    14. Diagnosis of human immunodeficiency virus in medical history.
    1. Indicios de enfermedad cardiovascular, respiratoria, urogenital, gastrointestinal/hepática (a excepción de la enfermedad subyacente), hematológica/inmunológica, de cabeza, oídos, ojos, nariz y garganta, dermatológica/del tejido conjuntivo, osteomuscular, metabólica/nutricional (a excepción de la enfermedad subyacente), endocrina (a excepción de la diabetes mellitus), neurológica/psiquiátrica, alérgica, cirugía mayor reciente u otras enfermedades relevantes que revele la anamnesis, la exploración física y/o las evaluaciones de laboratorio, que pudieran limitar la participación o la realización del estudio.
    2. Antecedentes de abdomen agudo.
    3. Antecedentes de colonopatía fibrosante.
    4. Antecedentes de síndrome de obstrucción intestinal distal (SOID) en los 6 meses previos a la inclusión en el estudio.
    5. Trasplante de órgano sólido o cirugía que afecte al intestino grueso, aparte de apendectomía.
    6. Cirugía del intestino delgado que afecte significativamente a la capacidad de absorción (p. ej., gastrectomía o pancreatectomía).
    7. Embarazo o lactancia.
    8. Un tipo de neoplasia maligna que afecte al tubo digestivo en los últimos 5 años.
    9. Enfermedad celíaca o enfermedad de Crohn.
    10. Alergia conocida a la pancreatina o a los componentes inactivos (excipientes) de las cápsulas de pancreatina.
    11. Sospecha de falta de cumplimiento o falta de cooperación.
    12. Uso de fármacos experimentales en los 30 días previos al inicio del estudio.
    13. Discapacidad mental o cualquier otra falta de aptitud, en opinión del investigador, que imposibilite la participación o la capacidad para completar el estudio.
    14. Diagnóstico de infección por el virus de inmunodeficiencia humana en los antecedentes patológicos.
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy criterion is the CFA. CFA will be calculated from fat intake and fat excretion, according to the formula:
    CFA (%) = 100 [fat intake ? fat excretion] / fat intake
    El criterio principal de valoración de la eficacia es el CAG. El CAG se calculará a partir del aporte y la excreción de grasas, según la fórmula:
    CAG (%) = 100 [aporte de grasas ? excreción de grasas] / aporte de grasas
    E.5.1.1Timepoint(s) of evaluation of this end point
    The CFA values will be compared between the Creon N 25000 and Creon® 25000 treatment periods.
    Los valores de CAG se comprarán entre los periodos de tratamiento con Kreon N 25000 y Kreon® 25000.
    E.5.2Secondary end point(s)
    The Secondary efficacy criteria are the coefficient of nitrogen absorption (CNA), stool fat and clinical symptomatology (stool frequency, stool consistency, abdominal pain, flatulence).
    The safety data collected during the study are vital signs, physical examination, safety laboratory values and adverses events.
    Los criterios secundarios de valoración de la eficacia son el coeficiente de absorción de nitrógeno (CAN), la grasa fecal y la sintomatología clínica (frecuencia de las deposiciones, consistencia de las heces, dolor abdominal y flatulencia).
    Los datos de seguridad que se recogerán durante el estudio incluyen: constantes vitales, exploración física, valores analíticos de la seguridad y acontecimientos adversos.
    E.5.2.1Timepoint(s) of evaluation of this end point
    The values will be compared between the Creon N 25000 and Creon® 25000 treatment periods.
    Safety parameters are assessed throughout the study.
    Los valores se comprarán entre los periodos de tratamiento con Kreon N 25000 y Kreon® 25000.
    Los parámetros de seguridad serán controlados a lo largo del estudio
    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 No
    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) 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 No
    E.8.1.6Cross over Yes
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    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 EEA7
    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
    Russian Federation
    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
    LVLP
    LVLP última visita último paciente
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months10
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months10
    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: 20
    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) Yes
    F.1.1.6.1Number of subjects for this age range: 20
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 19
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 1
    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
    For minor childs, the parents will have to give their consent.
    Para los menores de edad, los padres tendrán que otorgar su consentimiento
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state12
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 24
    F.4.2.2In the whole clinical trial 40
    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)
    none
    ninguno
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2013-12-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-12-18
    P. End of Trial
    P.End of Trial StatusCompleted
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