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    Summary
    EudraCT Number:2015-002570-20
    Sponsor's Protocol Code Number:AD-05-013
    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:2016-04-18
    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 number2015-002570-20
    A.3Full title of the trial
    Open label, randomized, crossover clinical trial to evaluate the efficacy of increasing doses of pancreatic enzymes against inhibition of acid gastric secretion in patients with exocrine pancreatic insufficiency secondary to chronic pancreatitis
    Ensayo clínico prospectivo, aleatorizado, cruzado, abierto para evaluar la eficacia del incremento de dosis de enzimas pancreáticas frente a la inhibición de la secreción ácida gástrica en pacientes con insuficiencia pancreática exocrina secundaria a pancreatitis crónica.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Optimizing treatment of maldigestion in patients with chronic pancreatitis
    A.4.1Sponsor's protocol code numberAD-05-013
    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 SponsorDepartment of gastroenterology. University Hospital of Santiago
    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 supportDpt. of Gastroenterology. University Hospital of Santiago
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationDpt. of Gastroenterology. university Hospital of Santiago
    B.5.2Functional name of contact pointClinical Trials Information
    B.5.3 Address:
    B.5.3.1Street AddressChoupana s/n
    B.5.3.2Town/ citysantiago de Compostela
    B.5.3.3Post code15706
    B.5.3.4CountrySpain
    B.5.4Telephone number34981951364
    B.5.6E-mailjuan.enrique.dominguez.munoz@sergas.es
    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 25000
    D.2.1.1.2Name of the Marketing Authorisation holderMylan
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Patients diagnosed of chronic pancreatitis with pancreatic exocrine insufficiency under pancreatic enzyme replacement therapy
    Pacientes diagnosticados de pancreatitis crónica con insuficiencia pancreática exocrina bajo tratamiento enzimático sustitutivo
    E.1.1.1Medical condition in easily understood language
    Pancreatic exocrine insufficiency (maldigestion) in patients with chronic pancreatitis
    Insuficiencia pancreática exocrina en pacientes con pancreatitis crónica
    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
    1.To evaluate the efficacy of increasing the doses of pancreatic enzymes against the inhibition of gastric acid secretion in patients with fat maldigestion despite of the treatment with conventional dose of pancreatic enzyme
    2. To evaluate whether there is a direct relationship between dose and response in the treatment of patients with pancreatic exocrine insufficiency.
    Evaluar la eficacia del aumento de dosis de tratamiento enzimático sustitutivo frente a la asociación de un inhibidor de la bomba de protones sobre la digestión grasa en pacientes con insuficiencia pancreática exocrina y maldigestión persistente a pesar de tratamiento enzimático sustitutivo convencional.
    Evaluar si existe una relación directa dosis-respuesta en el tratamiento enzimático sustitutivo de pacientes con IPE, evaluada mediante la eficacia del aumento de dosis de tratamiento enzimático sustitutivo, asociado o no a un inhibidor de la bomba de protones, sobre la digestión grasa en pacientes con insuficiencia pancreática exocrina y buena respuesta inicial al tratamiento enzimático sustitutivo convencional.
    E.2.2Secondary objectives of the trial
    Not applicable
    No aplicable
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Chronic Pancreatitis diagnosed by CT scan, endoscopy ultrasound (EUS) or MRI
    2. Pancreatic exocrine insufficiency diagnosed at inclusion by the 13C-MTG breath test and defined as a 13C-CCR <29%.
    3. Written informed consent
    1. Diagnóstico de pancreatitis crónica mediante ecografía endoscópica (USE), TAC o resonancia magnética.
    2. Diagnóstico de insuficiencia pancreática exocrina mediante test de aliento con 13C-MTG (porcentaje de 13CO2 recuperado en aire espirado inferior al 29%).
    3. Firma del consentimiento informado.
    E.4Principal exclusion criteria
    1. Age < 18 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. Any kind of uncured malignant disease.
    5. Need of any therapy known to influence pancreatic secretion (e.g. somatostatin and somatostatin analogs).
    6. Impossibility to stop the treatment with gastric acid inhibitors
    7. Any disease associated with a severe gastrointestinal dysmotility (e.g. long lasting diabetes mellitus, sclerodermia).
    8. Any kind of gastrointestinal or pancreatic surgery except appendicectomy or cholecistectomy
    9. Any experimental drug consumption in the four weeks prior to study entry
    10. Any kind of liver disease, celiac disease, inflammatory bowel disease or any other concomitant disease potentially affecting digestion or intestinal absorption.
    11. Any kind of severe restrictive lung disease which could potentially alter the result of the pancreatic function breath test.
    1. Edad inferior a 18 años.
    2. Embarazo o lactancia.
    3. Incapacidad para comprender el estudio y/o firmar el correspondiente consentimiento informado o imposibilidad para cumplir con las visitas y procedimientos del estudio
    4. Cualquier enfermedad maligna no considerada como curada
    5. Necesidad de cualquier tratamiento farmacológico que pueda alterar la función pancreática exocrina, fundamentalmente somatostatina y análogos de somatostatina.
    6. Imposibilidad de suspender el tratamiento con inhibidor de la secreción ácida gástrica.
    7. Cualquier enfermedad asociado a alteración grave de la motilidad gastrointestinal (ej. Diabetes de larga evolución, esclerodermia)
    8. Cirugía gastrointestinal o pancreática previa, excepto apendicectomía y colecistectomía
    9. Consumo de cualquier fármaco experimental en las cuatro semanas previas a la inclusión en el estudio
    10. Cualquier enfermedad hepática o intestinal (por ejemplo, cirrosis hepática grave, enfermedad celíaca, enfermedad inflamatoria intestinal) que afecten potencialmente a la absorción intestinal o al metabolismo de la grasa.
    11. Cualquier enfermedad pulmonar restrictiva grave que se asocie con una capacidad limitada para la eliminación de CO2
    E.5 End points
    E.5.1Primary end point(s)
    Absolute increase in fat digestion as measured by the 13C-CCR breath test with each treatment (A vs B vs C vs D)
    Incremento absoluto en el 13C-CRR con cada uno de los tratamientos administrados (A vs B vs C vs D).
    E.5.1.1Timepoint(s) of evaluation of this end point
    At the end of the study
    Al final del estudio
    E.5.2Secondary end point(s)
    1. Difference of fat digestion as measured by 13C-CCR breath test from basal to treatment A
    2. Percentage of patients who normalize the 13C-CCR breath test with each treatment (A vs B vs C vs D)
    3. Percentage of patients with pancreatic exocrine insufficiency despite of being under the standard treatment (treatment A)
    4. Percentage of patients with pancreatic exocrine insufficiency despite of being under the highest doses of enzymes (treatment D)
    5. Difference in fat digestion as measured by 13C-CCR breath test between different treatments (A vs B vs C vs D)
    6. Difference in fat digestion as measured by 13C-CCR breath test with treatments B and C in patients with pancreatic exocrine insufficiency despite of the treatment standard (treatment A) and in patients who normalize the digestion with treatment A
    7. Difference in fat digestion as measured by 13C-CCR breath test with treatment D, compared to treatments B and C.
    8. Correlation between the initial 13C-CCR breath test (severity of pancreatic exocrine insufficiency) and the doses of pancreatic enzymes required to normalize the 13C-CCR breath test
    9. Establish a cutoff for the 13C-MTG breath test in patients who require higher doses of pancreatic enzymes.
    10. Difference in symptoms and quality of life between different treatments (A vs B vs C vs D)
    11. Short term adverse events between different treatment ( A vs B vs C vs D)
    1. Diferencia de mejoría absoluta en el 13C-CCR con el tratamiento A respecto al basal.
    2. Porcentaje de pacientes que normalizan el 13C-CRR con cada uno de los tratamientos administrados (A vs B vs C vs D).
    3. Porcentaje de pacientes con maldigestión persistente a pesar del tratamiento enzimático sustitutivo a las dosis iniciales habituales (tratamiento A).
    4. Porcentaje de pacientes con maldigestión persistente a pesar del máximo tratamiento a estudio (tratamiento D).
    5. Diferencia de mejoría absoluta en el 13C-CCR entre los tratamientos administrados (A vs B vs C vs D).
    6. Diferencia de mejoría absoluta en el 13C-CCR entre los tratamientos B y C en pacientes en los que el tratamiento enzimático inicial (tratamiento A) no lograra normalizar la digestión, así como en aquellos con digestión normal con tratamiento A.
    7. Diferencia de mejoría absoluta en el 13C-CCR con el tratamiento D en comparación con B y C, según 1. Diferencia de mejoría absoluta en el 13C-CCR con el tratamiento A respecto al basal.
    2. Porcentaje de pacientes que normalizan el 13C-CRR con cada uno de los tratamientos administrados (A vs B vs C vs D).
    3. Porcentaje de pacientes con maldigestión persistente a pesar del tratamiento enzimático sustitutivo a las dosis iniciales habituales (tratamiento A).
    4. Porcentaje de pacientes con maldigestión persistente a pesar del máximo tratamiento a estudio (tratamiento D).
    5. Diferencia de mejoría absoluta en el 13C-CCR entre los tratamientos administrados (A vs B vs C vs D).
    6. Diferencia de mejoría absoluta en el 13C-CCR entre los tratamientos B y C en pacientes en los que el tratamiento enzimático inicial (tratamiento A) no lograra normalizar la digestión, así como en aquellos con digestión normal con tratamiento A.
    7. Diferencia de mejoría absoluta en el 13C-CCR con el tratamiento D en comparación con B y C, según la normalización o no de la digestión con B o C.
    8. Correlación entre el resultado basal de 13C-CRR (gravedad de insuficiencia pancreática exocrina) y la dosis de enzimas pancreáticas necesaria para normalizar el 13C-CRR.
    9. Resultado basal de 13C-CRR por debajo del cual no es suficiente la dosis inicial habitual de tratamiento enzimático sustitutivo (tratamiento A).
    10. Diferencia en síntomas y calidad de vida entre los distintos tratamientos evaluados (A vs B vs C vs D).
    11. Efectos secundarios a corto plazo de los distintos tratamientos evaluados (A vs B vs C vs D).
    E.5.2.1Timepoint(s) of evaluation of this end point
    At the end of the study
    Al final 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 No
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    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 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.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    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
    LVLS
    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 months
    E.8.9.1In the Member State concerned days
    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: 30
    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 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 state30
    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 Decision2016-02-25
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-07-30
    P. End of Trial
    P.End of Trial StatusOngoing
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