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    Summary
    EudraCT Number:2013-002819-10
    Sponsor's Protocol Code Number:M13-621
    National Competent Authority:Hungary - National Institute of Pharmacy
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2013-10-14
    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 ConcernedHungary - National Institute of Pharmacy
    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
    Kettős vak, randomizált, többcentrumos, keresztezett klinikai vizsgálat a Creon N és a Kreon zsíremésztésre gyakorolt hatásának összehasonlítására a cisztás fibrózis miatt kialakult exokrin hasnyálmirigy elégtelenségű 12 éves és ennél idősebb betegeken
    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
    A Creon N és a Kreon zsíremésztésre gyakorolt hatásának összehasonlítása a cisztás fibrózis miatt kialakult exokrin hasnyálmirigy elégtelenségű 12 éves és ennél idősebb betegeken
    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 nameCREON 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 codeCREON 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 Creon 25000
    D.2.1.1.2Name of the Marketing Authorisation holderAbbott Laboratories GmbH
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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 namePANCREATIN
    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
    Cisztás fibrózis miatt kialakult exokrin hasnyálmirigy elégtelenség
    E.1.1.1Medical condition in easily understood language
    maldigestion of diatery macronutients (pancreas not producing enough enzymes for digestion of fat, sugars and proteins) in Cystic Fibrosis
    Tápanyag lebontási zavar (a hasnyálmirigy nem termel elég enzimet a zsír, cukor és fehérje lebontásához) cisztás fibrózisban
    E.1.1.2Therapeutic area Diseases [C] - Immune System Diseases [C20]
    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).
    A Creon N 25 000 és Kreon 25 000 terápiás egyenértékűségének zsírfelszívódási koefficiensre (CFA) gyakorolt hatásának összehasonlítása a cisztás fibrózis (CF) miatti exokrin hasnyálmirigy rendellenességben (PEI) szenvedő serdülőkön és felnőtteken.
    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).
    A Creon N 25 000 és Kreon 25 000 hatásának vizsgálata a nitrogén felszívódási koefficiensre (CNA), a széklet zsírtartalmára és a klinikai tünetekre (székelés gyakorisága, széklet állaga, hasi fájdalom, puffadás).
    A biztonságosság értékelése
    A rövid ideig tartó Creon N 25 000 és Kreon 25 000 alkalmazás biztonságosságának értékelése a vitális jelek, testtömeg, fizikális vizsgálat, laborvizsgálat és nem várt események (AE) vonatkozásában.
    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. Önkéntes beleegyező nyilatkozat, amelyet a beteg, a szülő vagy a nyilatkozattételre jogosult aláír.
    2. 12 éves vagy ennél idősebb életkor.
    3. Olyan betegek, akik képesek minden fő és közbenső étkezéskor kapszulát lenyelni.
    4. CF diagnózis, amelyet két pozitív verejtékvizsgálat (klorid-szint) vagy genetikai vizsgálat igazolt.
    5. A hasnyálmirigy exokrin alulműködése, amelyet az alábbi igazol:
    a. CFA <70%, kiegészítés nélkül,
    b. vagy
    Humán széklet elasztáz <50 µg/g széklet
    6. Jelenleg is tartó kezelés több mint 3 hónapja, folyamatosan, azonos adagban, kereskedelmi forgalomban kapható hasnyálmirigy enzimet tartalmazó készítménnyel.
    7. Klinikailag stabil állapot akut légúti betegség jele nélkül a bevonást megelőző 1 hónapon belül.
    8. Stabil testsúly, azaz 3 hónapon belül 5%-nál nagyobb csökkenés nem következett be.
    9. Fogamzó képes nőknek gyógyászatilag elfogadott módszerrel kell védekezniük a vizsgálat alatt és további 30 napig a vizsgálati készítmény utolsó bevétele után. Elfogadott módszernek minősül: kétoldali petevezeték-lekötés, fogamzásgátló implantátum vagy fogamzásgátló injekció (Depo-Provera™) alkalmazása, intrauterin eszköz, vagy per os fogamzásgátló szedése 3 hónapon belül. A vizsgálati személy beleegyezik ezek további alkalmazásába a vizsgálat alatt, vagy más fogamzásgátló módszert alkalmaz, vagy kettős barrier módszert, amely a következők közül kettőnek a kombinációja: filmfólia, pesszárium, kondom vagy spermicid.
    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. Szív-érrendszeri, légúti, urogenitális, gasztrointesztinális és májra terjedő (kivéve a fennálló betegséget), hematológiai/immunológiai, fej-, fül-, szem-, orr-, garat-, dermatológiai/kötőszöveti, váz-izomrendszeri, anyagcsere/táplálkozási (kivéve fennálló betegséget), endokrin/táplálkozási (kivéve diabetes mellitus), neurológiai/pszichiátriai, allergiás, közelmúltban jelentős műtét, vagy egyéb releváns betegség jelei, amelyek a kórtörténetből, a fizikális és/vagy laboratóriumi vizsgálatból derültek ki, és gátolhatják a vizsgálatban való részvételt vagy végigvitelét.
    2. Akut has a kórtörténetben.
    3. Fibrotizáló kolonopátia a kórtörténetben.
    4. Distal intestinal obstruction syndrome (DIOS) a kórtörténetben, a beválasztást megelőző 6 hónapon belül.
    5. Transzplantáció vagy a vastagbelet érintő műtét (kivéve appendectomia).
    6. Vékonybél műtét, amely jelentősen befolyásolja a felszívódást (pl. gastrectomia vagy pancreatectomia).
    7. Terhesség vagy szoptatás.
    8. Bármilyen rosszindulatú betegség az elmúlt 5 évben, amely az emésztőrendszert érintette.
    9. Coeliákia vagy Crohn-betegség.
    10. Ismert allergia pankreatin-, vagy pankreatin-kapszulák összetevői iránt.
    11. Együttműködés vagy kooperáció feltételezhető hiánya.
    12. Vizsgálati készítmény szedése a bevonás előtti 30 napban.
    13. Mentális vagy bármi más alkalmatlanság, amely a vizsgáló véleménye szerint meggátolja, hogy az egyén a vizsgálatot lefolytassa.
    14. HIV-fertőzés diagnózisa a kórtörténetben.
    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
    Hatásosság elsődleges változója a CFA. A CFA-t a bevitt zsír és a kiválasztott zsírból számolják a következő képlet szerint:
    CFA (%) = 100 [zsírbevitel – kiválasztott zsír] / zsírbevitel
    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.
    Creon N 25000 és Kreon 25000 kezelési periódusok CFA értékeit hasonlítják össze.
    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.
    Másodlagos változók: CNA, széklet zsírtartalma, klinikai tünettan (székletürítés gyakorisága, széklet állaga, hasi fájdalom, puffadás). A biztonságosság értékelésekor a vitális jelek, testtömeg, fizikális vizsgálat, laborvizsgálat és nem várt események (AE) adatait kell figyelembe venni.
    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.
    Creon N 25000 és Kreon 25000 kezelési periódusok értékeit hasonlítják össze.
    A biztonságosságot az egész vizsgálat során értékelik.
    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 concerned4
    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
    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.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state10
    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
    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 Decision2013-11-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-11-14
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2014-08-25
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