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    Summary
    EudraCT Number:2013-005310-35
    Sponsor's Protocol Code Number:AD-03-013
    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:2014-07-22
    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 number2013-005310-35
    A.3Full title of the trial
    A phase IV double-blind, randomized, placebo-controlled, multi-center study with pancreatic enzyme replacement therapy (PERT) in subjects suffering from pancreatic exocrine insufficiency (PEI) after acute necrotizing pancreatitis.
    Estudio multicéntrico, aleatorizado, doble ciego, controlado con placebo, de tratamiento sustitutivo con enzimas pancreáticas (TSEP) en sujetos tras un episodio de pancreatitis aguda necrotizante que padecen insuficiencia exocrina pancreática (IPE)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Pancreatic enzyme replacement therapy (PERT) in subjects with pancreatic exocrine insufficiency (PEI) after acute necrotizing pancreatitis
    tratamiento sustitutivo con enzimas pancreáticas (TSEP) en sujetos tras un episodio de pancreatitis aguda necrotizante que padecen insuficiencia exocrina pancreática (IPE)
    A.4.1Sponsor's protocol code numberAD-03-013
    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 SponsorFundación para la Investigación en Enfermedades del Aparato Digestivo
    B.1.3.4CountrySpain
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportFundación para la Investigación en Enfermedades del Aparato Digestivo
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationFundación para la Investigación en Enfermedades del Aparato Digestivo
    B.5.2Functional name of contact pointJ. Enrique Domínguez Muñoz
    B.5.3 Address:
    B.5.3.1Street AddressUniversity Hospital of Santiago. Choupana s/n
    B.5.3.2Town/ citySantiago de Compostela
    B.5.3.3Post code15706
    B.5.3.4CountrySpain
    B.5.4Telephone number34981951364
    B.5.5Fax number34981955100
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Kreon 25.000
    D.2.1.1.2Name of the Marketing Authorisation holderAbbott Laboratories
    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.3.1Product nameCreon 25000
    D.3.2Product code PL 00512/0150
    D.3.4Pharmaceutical form Capsule
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCapsule
    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
    Patients 2 weeks after discharge from the hospital after an attack of acute necrotizing pancreatitis
    Pacientes dos semanas tras el alta hospitalaria despues de un episodio de pancreatitis aguda necrotizante
    E.1.1.1Medical condition in easily understood language
    Patients after an attack of acute necrotizing pancreatitis
    Pacientes tras un episodio de pancreatitis aguda necrotizante
    E.1.1.2Therapeutic area Diseases [C] - Digestive System Diseases [C06]
    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 demonstrate the superior efficacy of pancreatic enzymes over placebo in improving fat digestion in subjects suffering from PEI after an attack of acute necrotizing pancreatitis. The primary efficacy parameter will be the change in the 13C-cumulative recovery rate (CRR) from baseline to treatment as evaluated by the 13C-MTG breath test
    Demostrar la eficacia del tratamiento enzimático sustitutivo en comparación con placebo en la mejoría de la digestión en pacientes con insuficiencia pancreática exocrina secundaria a pancreatitis aguda necrotizante. El parámetro de eficacia primaria será el cambio en el porcentaje de 13CO2 recuperado en aire espirado durante el tratamiento en comparación con el basal (antes de inicio de tratamiento) evaluado mediante test de aliento con 13C-MTG
    E.2.2Secondary objectives of the trial
    1. To investigate the incidence of PEI after acute necrotizing pancreatitis and the potential factors increasing the risk of PEI, among them age, etiology, extent and location of the necrosis, complications such as ductal disruption, pseudocyst, abscess, and need for surgical or endoscopic necrosectomy.
    2. To evaluate the effect of PERT compared to placebo on abdominal symptoms (abdominal pain, distention and discomfort, postprandial fullness, early satiety, meteorism, bloating, stool frequency and consistency, flatulence), quality of life (QoL SF-36 and EORT QLQ-C30) and nutritional status (hematologic and biochemical nutritional parameters).
    3. To evaluate the safety and tolerability of PERT, including vital signs, safety laboratory values and adverse events.
    1. Investigar la incidencia de IPE en pacientes tras episodio de pancreatitis aguda necrotizante y factores potencialmente asociados a IPE, entre ellos edad, etiología de la pancreatitis, extensión y localización de la necrosis, otras complicaciones locales, presencia de fallo orgánico, comorbilidades asociadas y necesidad de necrosectomía endoscópica o quirúrgica.
    2. Evaluar el efecto del tratamiento enzimático sustitutivo comparado con placebo sobre la presencia e intensidad de síntomas abdominales (dolor o distensión abdominal, pesadez postprandial, saciedad precoz, meteorismo, flatulencia, frecuencia y consistencia de deposiciones) tras el alta hospitalaria, calidad de vida (QoL SF-36 y EORT QLQ-C30) y estado nutricional (parámetros nutricionales antropométricos y bioquímicos).
    3. Evaluar la seguridad y tolerancia del tratamiento enzimático sustitutivo en pacientes tras pancreatitis aguda necrotizante, incluyendo signos vitales, valores de laboratorio y eventos adversos.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Patients between 18 and 80 years old, 2 weeks after discharge from the hospital after an attack of acute necrotizing pancreatitis as defined by a CT scan Balthazar score of ?6.
    2. Written informed consent.
    3. PEI diagnosed at inclusion by the 13C-MTG breath test and defined as a 13C-CCR <29%.
    o Pacientes de edad comprendida entre 18 y 80 años, dos semanas tras el alta hospitalaria tras un episodio de pancreatitis aguda necrotizante definida por la clasificación de Balthazar de TAC abdominal (puntuación ?6) (25).
    o Firma del consentimiento informado específico para la participación en el estudio.
    o Diagnóstico de insuficiencia pancreática exocrina confirmado mediante test de aliento con 13C-MTG y definida como un porcentaje de 13C recuperado en aire espirado inferior al 29%.
    E.4Principal exclusion criteria
    1. Age < 18 years or > 80 years.
    2. Pregnancy or lactancy.
    3. Unwillingness or inability to understand the study and sign the consent, or to accomplish with the visits and procedures of the study.
    4. Diagnosis of chronic pancreatitis or pancreatic cancer.
    5. Any kind of uncured malignant disease.
    6. Need of any therapy known to influence pancreatic secretion (e.g. somatostatin and somatostatin analogs).
    7. Need for any therapy other than gastric acid inhibitors known to influence abdominal symptoms (e.g. prokineticum, opioids).
    8. Any disease associated with a severe gastrointestinal dysmotility (e.g. long lasting diabetes mellitus, sclerodermia).
    o Edad inferior a 18 años.
    o Embarazo o lactancia.
    o Mujeres en edad fértil que no usen anticonceptivo hormonal oral o un dispositivo intrauterino.
    o Negativa a participar en el estudio.
    o Incapacidad para comprender el estudio y/o firmar el correspondiente consentimiento informado.
    o Imposibilidad de cumplir con las visitas y procedimientos del estudio.
    o Diagnóstico de pancreatitis crónica, cáncer de páncreas o cualquier otra enfermedad o condición potencialmente causante de insuficiencia pancreática exocrina.
    o Cirugía gastrointestinal o pancreática previa, excepto apendectomía y colecistectomía.
    o Cualquier enfermedad maligna no considerada como curada.
    o Alergia o hipersensibilidad conocida a proteínas de origen porcino.
    o Necesidad de cualquier tratamiento farmacológico que pueda alterar la función pancreática exocrina, fundamentalmente somatostatina y análogos de somatostatina.
    o Gastroparesia grave asociada a vómitos frecuentes y malnutrición secundaria.
    o Consumo de cualquier fármaco experimental en las cuatro semanas previas a la inclusión en el estudio.
    E.5 End points
    E.5.1Primary end point(s)
    Difference in fat digestion as measured by the 13C-MTG breath test (13C-CCR) from basal to therapy (PERT or placebo).
    Diferencia en la digestión de las grasas según lo medido por la prueba de aliento 13C-MTG (13C-CCR) de basal a terapia (PERT o placebo).
    E.5.1.1Timepoint(s) of evaluation of this end point
    Four weeks
    4 semanas
    E.5.2Secondary end point(s)
    Difference in symptoms, QoL and nutritional status between PERT and placebo at month 1 (symptoms), 3 and 6 after randomization.
    Diferencia en los síntomas, QoL y dstado nutricional entre PERT y placebo al mes (síntomas), 3 y 6 meses tras la randomización
    E.5.2.1Timepoint(s) of evaluation of this end point
    Three and six months
    3 y 6 meses
    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) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised No
    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 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 No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    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
    Severe adverse events cosidered to be related to the study drug.
    Major protocol violation
    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
    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: 50
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 18
    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 state68
    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
    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 Decision2014-08-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-07-31
    P. End of Trial
    P.End of Trial StatusOngoing
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