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    Summary
    EudraCT Number:2009-012842-21
    Sponsor's Protocol Code Number:PR-005
    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:2013-05-10
    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 number2009-012842-21
    A.3Full title of the trial
    Randomised, Double-Blind, Active-Controlled, Two-Treatment, Crossover,
    Multinational, Multicentre Study to Compare Two Pancreatic Enzyme Products in theTreatment of Exocrine Pancreatic Insufficiency in Subjects With Cystic Fibrosis
    Randomizált, kettős vak, aktív kontrollos, két kezelést tartalmazó, keresztezett, nemzetközi, multicentrikus vizsgálat két hasnyálmirigyenzim-készítmény összehasonlítására, cisztás fibrózisban szenvedő alanyok exokrin hasnyálmirigy-elégtelenségének kezelése során
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Treatment of Exocrine Pancreatic Insufficiency in subjects with Cystic Fibrosis
    A.4.1Sponsor's protocol code numberPR-005
    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 SponsorAptalis Pharma US Inc.
    B.1.3.4CountryUnited States
    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 supportAptalis Pharma SAS
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAptalis Pharma SAS
    B.5.2Functional name of contact pointGilles Chauviere
    B.5.3 Address:
    B.5.3.1Street AddressRoute de Bû
    B.5.3.2Town/ cityHoudan
    B.5.3.3Post code78550
    B.5.3.4CountryFrance
    B.5.4Telephone number+33130461900
    B.5.5Fax number+33130596547
    B.5.6E-mailgchauviere@aptalispharma.com
    D. IMP Identification
    D.IMP: 1
    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 25 000
    D.2.1.1.2Name of the Marketing Authorisation holderAbbott Arzneimittel 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.3.1Product nameKREON 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 INNPancreas Powder
    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 Other
    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 Yes
    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 Yes
    D.2.1.1.1Trade name Zenpep
    D.2.1.1.2Name of the Marketing Authorisation holderAptalis Pharma US Inc.
    D.2.1.2Country which granted the Marketing AuthorisationUnited States
    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 nameEUR-1008
    D.3.2Product code EUR-1008
    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 INNPancreas Powder
    D.3.9.1CAS number 53608-75-6
    D.3.9.2Current sponsor codeEUR-1008
    D.3.9.3Other descriptive namePANCREATIN
    D.3.9.4EV Substance CodeSUB14750MIG
    D.3.10 Strength
    D.3.10.1Concentration unit Other
    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 Yes
    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
    Exocrine pancreatic insufficiency associated with cystic fibrosis
    E.1.1.1Medical condition in easily understood language
    Pancreas is not able to produce enough digestive enzymes in patients with cystic fibrosis
    E.1.1.2Therapeutic area Diseases [C] - Digestive System Diseases [C06]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level HLGT
    E.1.2Classification code 10015674
    E.1.2Term Exocrine pancreas conditions
    E.1.2System Organ Class 10017947 - Gastrointestinal disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10011762
    E.1.2Term Cystic fibrosis
    E.1.2System Organ Class 10010331 - Congenital, familial and genetic disorders
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of the study is to evaluate the safety and efficacy of EUR-1008 as compared to Kreon® in the treatment of EPI associated with CF in subjects 12 years of age and older who are able to swallow the capsules whole.
    A vizsgálat elsődleges célkitűzése az EUR-1008 és a Kreon® biztonságos¬ságának és hatásosságának összehasonlítása a cisztás fibrózissal járó exokrin hasnyálmirigy-elégtelenség kezelésében olyan, legalább 12 éves alanyoknál, akik képesek a kapszulákat egészben lenyelni.
    E.2.2Secondary objectives of the trial
    - Controlling signs and symptoms of EPI, including stool frequency, consistency, fat in stool, abdominal pain, bloating, and flatulence (as recorded in the subject diary);
    - Change in body weight;
    - Total cholesterol, calculated low-density lipoprotein cholesterol (LDL-C), high-density lipoprotein cholesterol (HDL-C), and fat-soluble vitamins A, D, and E;
    - Coefficient of nitrogen absorption (CNA); and
    - Impact on overall health, daily life, perceived well-being, and symptoms using the Cystic Fibrosis Questionnaire (CFQ).
    • az exokrin hasnyálmirigy-elégtelenség jeleinek és tüneteinek kontrollja, beleértve a székletürítés gyakoriságát, a széklet konzisztenciáját, a székletben lévő zsírt, a hasi fájdalmat, a puffadást és a gyomor-/bélgázképződést (az alany naplójában rögzített adatok alapján);
    • a testsúly változása;
    • összkoleszterin, számított alacsony sűrűségű lipoprotein koleszterin (LDL-C), magas sűrűségű lipoprotein koleszterin (HDL-C), valamint a zsíroldékony A, D és E vitamin;
    • a nitrogénabszorpciós együttható (CNA); valamint
    • az általános egészségi állapotra, a mindennapi életre, az érzékelt jóllétre, valamint a tünetekre kifejtett hatás, a cisztás fibrózisra vonatkozó kérdőív (CFQ) használatával.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Definitive diagnosis of CF based on the following:
    - One clinical feature consistent with CF and
    - Either a genotype with 2 identifiable mutations known to cause CF or a sweat chloride concentration >60 mEq/L by quantitative pilocarpine iontophoresis;
    2. Pancreatic insufficiency documented by a monoclonal faecal elastase
    -100 μg/g stool at screening (test results within the previous 24 months are acceptable);
    3. Currently receiving pancreatic enzyme replacement therapy;
    4. Adequate nutritional status based on the following: body mass index (BMI) >19 kg/m2 in adult subjects or a BMI percentile
    -10th percentile for age in adolescent (12 to 17 years age group) subjects;
    5. Are clinically stable with no evidence of concomitant illness, or acute upper or lower respiratory tract infection that requires antibiotics during the 7-day interval prior to screening and preceding entry into this clinical study;
    6. Subjects likely to adhere to a prescribed diet, vitamin, and nutritional supplements usage;
    7. Dose stabilisation, defined as no change in the number of capsules taken per day for 3 consecutive days before the end of the Screening Period;
    8. Willing to be switched from existing pancreatic enzyme treatment;
    9. Women of childbearing potential must use a medically acceptable birth control method for the duration of the study (ie, from screening) and for 30 days thereafter;
    - Women who are not of childbearing potential will be defined as no attainment of menses, confirmed sterility, undergone surgical procedure (TAH and or oophorectomy), or have undergone menopause (12 consecutive months without menses and substantiated by an appropriate follicle stimulating hormone [FSH]/ luteinizing hormone [LH] test for subjects under 65 years of age);
    10. Written informed consent obtained; and
    11. Appropriate assent from the minor if consent is provided by parent/guardian according to national legal requirements.
    E.4Principal exclusion criteria
    1. Age <12 years;
    2. Known contraindication, hypersensitivity, or intolerance to pork or other porcine PEPs;
    3. Current uncontrolled diabetes mellitus;
    4. History of solid organ transplantation;
    5. History of surgery affecting the bowel function and weight gain;
    6. History or presence of fibrosing colonopathy;
    7. History of any other clinically significant cardiac, renal, neurological, gastrointestinal, hepatic, or endocrine disease, with sequelae and/or treatment requirements that could interfere with the results of the study;
    8. Presence of hepatic insufficiency that in the opinion of the investigator could interfere witht he conduct of the study.
    9. Any acute respiratory infection in the previous 7 days requiring antibiotics;
    10. Cancer or any other chronic disease with life expectancy <2 years;
    11. Subjects treated with oral steroids in the last 8 weeks;
    12. Subjects receiving nutritional supplements containing high doses (>= 30%) of medium-chain triglycerides (MCTs) to maintain weight gain;
    13. Subjects who, in the opinion of the investigator, have a significant medical and/or mental disease that would compromise the subject’s welfare, pose an unacceptable risk to him/her, or confound the study results;
    14. Subjects with evidence of alcohol or drug abuse that, in the opinion of the investigator, could lead to noncompliance with study requirements, or subjects otherwise unable to understand the nature, scope, and possible consequences of the study;
    15. Positive urine (dipstick) pregnancy test (for subjects of childbearing potential);
    16. Pregnant or lactating women;
    17. Subjects who have been previously enrolled in this study;
    18. Participation in an interventional clinical study within 30 days of the screening visit or as applicable per specific country regulations/guidelines. Partecipation in observational studies is not an exclusion;
    19. Presence of any condition known to increase faecal fat loss including tropical sprue. bacterial bowel infection , pseudomembranous colitis, biliary and pancreatic cancer, rediation enteritis and Whipple's disease;
    20. Presence of any uncontrolled condition known to increase faecal fat loss including celiac disease, Crohn’s disease, and lactose intolerance.
    21. Subjects who require chronic treatment with narcotics; or
    22. Subjects who cannot swallow size 00 capsules.
    E.5 End points
    E.5.1Primary end point(s)
    CFA = coefficient of fat absorption
    E.5.1.1Timepoint(s) of evaluation of this end point
    At the end of each treatment period
    E.5.2Secondary end point(s)
    1. Difference in change in body weight during the 2 treatment periods
    2. Differences in the CNA during the 2 treatment periods
    3. Incidences of clinical signs and symptoms of EPI
    4. The difference in change in CFQ scale from baseline to the end of each treatment period
    5. Effect on total cholesterol, calculated LDL-C, HDL-C, and fat-soluble vitamins A, D,
    E.5.2.1Timepoint(s) of evaluation of this end point
    At the end of each treatment period
    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 No
    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 concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA41
    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 Yes
    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
    Last Subject Last Visit
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months8
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months6
    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: 43
    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: 43
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 43
    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 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 No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state28
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 86
    F.4.2.2In the whole clinical trial 86
    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)
    After completion of the trial subject will be treated according to standard care
    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 Decision2013-06-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-06-24
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2014-01-03
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