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    Summary
    EudraCT Number:2016-005063-13
    Sponsor's Protocol Code Number:Repha_1410
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2017-03-09
    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 ConcernedGermany - BfArM
    A.2EudraCT number2016-005063-13
    A.3Full title of the trial
    Investigation of Efficacy, Safety, Acid Resistance and Mode of Action of Lipases in Nortase and Kreon with the Pancreo-Lip 13C breath test in Subjects with Severe Exocrine Pancreatic Insufficiency
    Untersuchung der Wirksamkeit, Sicherheit, Säurestabilität und des Wirkungsmechanismus der Lipasen in Nortase und Kreon mit Pancreo-Lip 13C-Atemtest in Teilnehmern mit einer schweren exokrinen Pankreasinsuffizienz
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Investigation of Efficacy, Safety, Acid Resistance and Mode of Action of Lipases in Nortase and Kreon with the Pancreo-Lip 13C breath test in Subjects with Severe Exocrine Pancreatic Insufficiency
    Untersuchung der Wirksamkeit, Sicherheit, Säurestabilität und des Wirkungsmechanismus der Lipasen in Nortase und Kreon mit Pancreo-Lip 13C-Atemtest in Teilnehmern mit einer schweren exokrinen Pankreasinsuffizienz
    A.3.2Name or abbreviated title of the trial where available
    NORTPANK
    NORTPANK
    A.4.1Sponsor's protocol code numberRepha_1410
    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 SponsorRepha 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 supportRepha GmbH, Langenhagen
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMediconomics GmbH
    B.5.2Functional name of contact pointClinical Research
    B.5.3 Address:
    B.5.3.1Street AddressMisburger Straße 81B
    B.5.3.2Town/ cityHannover
    B.5.3.3Post code30625
    B.5.3.4CountryGermany
    B.5.4Telephone number004905115609980
    B.5.5Fax number0049051156099820
    B.5.6E-mailinfo@mediconomics.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 Yes
    D.2.1.1.1Trade name Nortase
    D.2.1.1.2Name of the Marketing Authorisation holderRepha 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
    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 Yes
    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® 10 000
    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.3.11 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: 3
    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 Nexium® mups 40 mg
    D.2.1.1.2Name of the Marketing Authorisation holderAstraZeneca 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 Tablet
    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 Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    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
    Severe exocrine pancreatic insufficiency
    schwere exokrine Pankreasinsuffizienz
    E.1.1.1Medical condition in easily understood language
    Severe loss in pancreatic activity
    Schwerer Verlust der Bauchspeicheldrüsenfunktion
    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 20.0
    E.1.2Level LLT
    E.1.2Classification code 10033628
    E.1.2Term Pancreatic insufficiency
    E.1.2System Organ Class 100000004856
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Comparison of the total 13CO2-emission values (=calculated as Area Under the Curve (AUC)t=0 240 min) between Nortase and Kreon.
    Vergleich der Gesamt-13CO2-Emmission (berechnet als Area Under the Curve (AUC)t=0 240 min) zwischen Nortase und Kreon.
    E.2.2Secondary objectives of the trial
    Efficacy
    - Comparison of the total 13CO2-emission data (AUCt=0-240 min) between Nortase and Kreon + Nortase
    - Comparison of the total 13CO2-emission data (AUCt=0-240 min) between Nortase and Kreon + PPI
    - Comparison of the total 13CO2-emission data (AUCt=0-240 min) between Kreon and Kreon + PPI
    - Comparison of the total 13CO2-emission data (AUCt=0-240 min) between Kreon and Kreon + Nortase
    - Comparison of the total 13CO2-emission data (AUCt=0-240 min) between Kreon + PPI and Kreon + Nortase
    - Comparison of the time until the first measurable 13CO2-signal (t1) occurs in the respective treatment groups
    - Comparison of the time to reach the maximum lipase activity (tmax) in the respective treatment groups
    - Comparison of the maximum lipase activity (vmax) of administered therapy in the respective treatment groups.

    Safety and Tolerability
    - Type, frequency and severity of documented AEs and SAEs
    - Tolerability of the study medication (assessed by the subject)
    Wirksamkeit
    - Vergleich der Gesamt-13CO2-Emmission (AUCt=0-240 min) zw. Nortase und Kreon + Nortase (Add-On)
    - Vergleich der Gesamt-13CO2-Emmission (AUCt=0-240 min) zw. Nortase und Kreon + PPI (Säurefestigkeit)
    - Vergleich der Gesamt-13CO2-Emmission (AUCt=0-240 min) zwischen Kreon und Kreon + PPI (Säurefestigkeit)
    - Vergleich der Gesamt-13CO2-Emmission (AUCt=0-240 min) zwischen Kreon und Kreon + Nortase (Add-On)
    - Vergleich der Gesamt-13CO2-Emmission (AUCt=0-240 min) zwischen Kreon + PPI und Kreon + Nortase
    - Vergleich der Zeit bis zum ersten messbaren 13CO2-Signal (t1) in den jeweiligen Behandlungsgruppen
    - Vergleich der Zeit bis zum Erreichen der maximalen Lipaseaktivität (tmax) in den jeweiligen Behandlungsgruppen
    - Vergleich der maximalen Lipaseaktivität (vmax) in den jeweiligen Behandlungsgruppen

    Sicherheit und Verträglichkeit
    - Art, Frequenz und Schweregrad der dokumentierten UEs und SUEs
    - Verträglichkeit der Studienmedikation (vom Teilnehmer bewertet)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    -Subjects suffering from a severe exocrine pancreatic insufficiency at screening (visit 1) verified by the medical record of the patient and an elastase-1 ELISA (< 100 µg elastase-1/g stool)
    - Discontinuation of PPI treatment 7 days prior to each of the following visits 2 - 6 (exception: study medication in order to prepare treatment D)
    - Subjects of both sexes aged ≥ 18 years
    - Written informed consent signed by the subject
    - The subject is willing and in a constitution to attend to the study over the whole duration, to finish the study and to comply with given instructions during the course of the study.
    - Teilnehmer, die an einer schweren exokrinen Pankreasinsuffizienz (dokumentiert durch die Krankenakte und <100 µg Elastase-1/g Stuhl im ELISA) zum Zeitpunkt des Screening (Visite 1) leiden
    - Stopp der PPI Einnahme 7 Tage vor einer jeden der folgenden Visiten 2 - 6 (Ausnahme: Studienmedikation zur Vorbereitung der Behandlung D)
    - Teilnehmer beiderlei Geschlechts ≥ 18 Jahre
    - Schriftliche Einverständniserklärung
    - Der Studienteilnehmer ist bereit und in einer Verfassung an der Studie teilzunehmen, die Studie zu beenden und Instruktionen während der Studie zu befolgen.
    E.4Principal exclusion criteria
    - Acute pancreatitis or an acute episode within the course of a chronic pancreatitis 4 weeks before the determined study start or during the study
    - Chronic inflammatory intestinal disease
    - Bowel stenoses, which are known complications in subjects suffering from cystic fibrosis
    - Severe disease of lung, liver or kidney
    - Former surgeries in the gastrointestinal region with detectable influence on lipid-absorption and altered gastric passage (i.e. Whipple procedure, pancreaticoduodenectomy). Patients with pylorus-preserving pancreatic head resection, right sided pancreas resection, duodenum preserving pancreatic head resection might be included.
    - Impaired lipid-metabolism requiring optimal pharmaceutical treatment (cholesterol >400 mg/dL, triglycerides >400 mg/dL)
    - Treatment with antibiotics within 8 days before the breath test
    - Current concomitant medication with laxatives or medication influencing the intestinal motility 24 hours before a visit
    - Concomitant PPI intake 7 days before each visit (excluding study medication in preparation of Treatment D)
    - Any long-term medication that directly influences the pH of the gastrointestinal tract 7 days prior to each of the following visits (except Treatment D). This includes but is not limited to PPI, H2 blocking agents, COX inhibiting agents (NSAIDs)
    Acute, symptomatic treatment with pH-modulating agents (e.g. Bullrich Salz) or COX-inhibiting agents (e.g. ASS) is allowed until 24 hours prior to each visit (except for treatment D).
    - Known intolerances/allergies/hypersensitivities:
    o Lactose intolerance
    o Known mold-Allergy, incompatibility/allergy/sensitivity against Aspergillus oryzae and/or Rhizopus oryzae
    o Celiac disease, wheat allergy and wheat sensitivity; sensitivity, allergy or incompatibility to other cereals.
    o hereditary fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency
    o known incompatibility/allergy/sensitivity against hazelnuts or soy or any other component of Nutella®
    o to pork (pork allergy) or cultural rejection of pork ingredients
    o against one of the components of Nortase®: magnesium-stearate, lactose-monohydrate, hydroxypropylmethyl-cellulose (HPMC), coloring agents: iron oxide red E 172, titanium dioxide E 171
    o against one of the components of Kreon®: cetyl alcohol, triethylcitrate, dimeticone 1000, macrogol 4000, hypromellose phthalate, gelatin, sodiummdodecylsulfate, titanium dioxide, iron[III]-oxide, iron[III]-hydroxide, iron[II,III]-oxide
    o to the active substance esomeprazole in Nexium mups®, to substituted benzimidazoles or to any of the excipients listed: Glycerol monostearate 40-55, hyprolose, hypromellose, iron[III]-oxide (E 172), magnesium stearate (Ph.Eur.), methacrylic acid-ethyl acrylate-copolymer (1:1) (Ph.Eur.), microcrystalline cellulose, hard paraffin, macrogol 6000, polysorbate 80, crospovidone, sodium stearyl fumarate (Ph.Eur.), sugar-starch-pellets (sucrose and maize starch), talcum, titan dioxide (E 171), triethyl Citrate
    - Concomitant use of the following medicinal products:
    o nelfinavir
    o atazanavir
    o clopidogrel
    o ketoconazole, itraconazole or voriconazole
    o erlotinib
    o citalopram, imipramine or clomipramine
    o diazepam
    o cilostazol
    o cisapride
    o digoxin
    o methotrexate
    o tacrolimus
    o rifampicin
    o St. John’s wort (Hypericum perforatum)
    o phenytoin in epileptic patients
    o warfarin or other coumarine derivatives.
    - Participation in another clinical study during the study and within the previous 30 days to screening
    - Malignant disease of pancreas within the previous 5 years
    - Known HIV positivity
    - Pregnancy, lactation or the planning of a pregnancy in female participants
    - Subjects with a disease or in a specific condition/situation, which will present a significant risk - according to the principal investigators opinion - and will therefore affect or significantly influence the outcome of the study.
    - Alcohol abuse and/or substance/drug abuse leading to a restricted cognitive capability documented by the investigator
    - Severe mental illnesses
    - Persons who are institutionalized by court order or regulatory action
    - Sponsor-dependent persons
    • akute Pankreatitis oder eine akute Episode bei chronischer Pankreatitis innerhalb von 4 Wochen vor Studienstart oder während der Studie
    • chronische entzündliche Darmerkrankungen
    • gastrointestinale Stenose, die eine bekannte Komplikation in Teilnehmern mit cystischer Fibrose ist
    • schwerwiegende Erkrankungen der Lunge, Leber oder Niere
    • Frühere Operationen der gastrointestinalen Region mit messbarem Einfluss auf die Fettabsorption und die gastrische Passage (d. h. Whipple Operation, PankreaFormer surgeries in the gastrointestinal region with detectable influence on lipid-absorption and altered gastric passage (i.e. Whipple procedure, Duodenopankreatektomie).

    Patienten mit Pylorus erhaltender Pankreaskopfresektion, rechtsseitiger Pankreasresektion, Duodenum erhaltender Pankreaskopfresektion können eingeschlossen werden.
    • beeinträchtigter Lipidmetabolismus, welcher eine optimale pharmakologische Behandlung benötigt (Cholesterol >400 mg/dL, Triglyceride >400 mg/dL)
    • Behandlung mit Antibiotika 8 Tage vor Studienstart
    • gleichzeitige Einnahme von Laxativa oder Medikation, die die intestinale Motilität beeinflusst 24 h vor der Visite
    • gleichzeitige Einnahme von PPI 7 Tage vor einer Visite (mit Ausnahme der Vorbereitung von Behandlung D)
    • jegliche Langzeit-Medikation, die den pH Wert des Magens direkt beeinflusst muss 7 Tage vor einer folgenden Visite abgesetzt werden. Dies schließt unter anderem PPI, H2-Blocker, COX-Inhibitoren (NSAIDs) ein.
    Symptomatische Akutbehandlungen mit pH modulierenden Agentien (z. B. Bullrich Salz) oder COX inhibierenden Agentien (z. B. ASS) sind bis zu 24 h vor jeder Visite erlaubt (Ausnahme: Behandlung D).
    • Bekannte Intoleranzen / Allergien/ Überempfindlichkeiten:
    o Laktoseintoleranz
    o Bekannte Schimmelpilzallergie, bekannte Unverträglichkeit / Allergie / Überempfindlichkeit gegenüber Aspergillus oryzae und/oder Rhizopus oryzae
    o Zölliakie, Weizenallergie und Weizenunverträglichkeit; Überempfindlichkeit gegenüber anderer Getreidearten
    o hereditäre Fruktoseintoleranz, Glucose-Galaktose Malabsorption oder Saccharose-Isomaltase Insuffizienz
    o bekannte Unverträglichkeit / Allergie / Überempfindlichkeit gegenüber Haselnüssen, Soja oder anderer Komponenten von Nutella®
    o Überempfindlichkeit gegenüber Schweinefleisch (Allergie) oder kulturelle Ablehnung von Schweinefleisch
    o Überempfindlichkeit gegenüber einer oder mehrerer Komponenten von Nortase®: Magnesiumstearat, Lactose-Monohydrat, Hydroxpropylmethyl-Cellulose (HPMC), Farbstoffe: Eisenoxid rot E 172, Titandioxid E 171
    o Überempfindlichkeit gegenüber einer oder mehrerer Komponenten von Kreon®: Cetylalkohol, Triethylcitrat, Dimeticon 1000, Macrogol 4000, Gelatine, Natriumdodecylsulfat, Titandioxid, Eisen(III)-oxid, Eisen(III)-hydroxid-oxid × H2O, Eisen(II,III)-oxid
    o HypromellosephthalatÜberempfindlichkeit gegenüber einer oder mehrerer Komponenten von Nexium® mups 40 mg: Glycerolmonostearat 40 – 55, Hyprolose, Hypromellose, Eisen(III)-oxid (E 172), Magnesiumstearat, (Ph. Eur.), Methacrylsäure-Ethylacrylat-Copolymer (1 : 1) (Ph. Eur.), mikrokristalline Cellulose, Hartparaffin, Macrogol, 6000, Polysorbat 80, Crospovidon, Natriumstearylfumarat (Ph. Eur.), Zucker-Stärke-Pellets (Sucrose und Maisstärke), Talkum, Titandioxid (E 171), Triethylcitrat
    • Gleichzeitige Einnahme der folgenden Medikamente:
    o Nelfinavir
    o Atazanavir
    o Clopidogrel
    o Ketoconazol, Itraconazol, Voriconazol
    o Erlotinib
    o Citalopram, Imipramin or Clomipramine
    o Diazepam
    o Cilostazol
    o Cisapride
    o Digoxin
    o Methotrexat
    o Tacrolismus
    o Rifampicin
    o Johanniskraut
    o Phenytoin bei Epilepsie
    • Teilnehmer, welche 30 Tage vor erstmaliger Einschlussuntersuchung oder während der klinischen Prüfung an anderen Arzneimittelstudien teilnahmen oder teilnehmen
    • Teilnehmer mit einer malignen Erkrankung innerhalb der vorangegangenen 5 Jahre
    • Bekannte HIV Infektion
    • Schwangerschaft und Stillzeit
    • Teilnehmer mit einer Erkrankung oder in einer Situation, die nach Meinung des Prüfarztes den Teilnehmer einem signifikanten Risiko aussetzen, die Studienergebnisse beeinträchtigen oder diese erheblich beeinflussen könnten
    • Bestehender Alkoholabusus bzw. Medikamenten- oder Drogenmissbrauch, welcher nach Einschätzung des Prüfarztes zu einer eingeschränkten kognitiven Leistungsfähigkeit führt
    • Schwerwiegende Erkrankungen der Psyche
    • Personen, die aufgrund behördlicher oder gerichtlicher Anordnung in einer Anstalt untergebracht wurden
    • Personen, die vom Sponsor oder von einer vom Sponsor beauftragten an der Durchführung der Studie beteiligten Stelle abhängig sind
    E.5 End points
    E.5.1Primary end point(s)
    The primary objective is the comparison of the total 13CO2-emission values (=calculated as Area Under the Curve (AUC)t=0 240 min) between Nortase (B) and Kreon (A).

    Treatment A: 4 capsules of Kreon

    Treatment B: 6 capsules of Nortase
    Vergleich der Gesamt-13CO2-Emmission (berechnet als Area Under the Curve (AUC)t=0 240 min) zwischen Nortase (A) und Kreon (B).

    Behandlung A: 4 Kapseln Kreon 10 000 (40 000 Ph. Eur.-Einheiten)

    Behandlung B: 6 Kapseln Nortase (42 000 Ph. Eur.-Einheiten)
    E.5.1.1Timepoint(s) of evaluation of this end point
    after administration of treatments A and B

    Treatment A: 4 capsules of Kreon

    Treatment B: 6 capsules of Nortase
    Nachdem Behandlung A und B erfolgt sind.

    Behandlung A: 4 Kapseln Kreon 10 000 (40 000 Ph. Eur.-Einheiten)

    Behandlung B: 6 Kapseln Nortase (42 000 Ph. Eur.-Einheiten)
    E.5.2Secondary end point(s)
    Efficacy

    - Comparison of the total 13CO2-emission data (AUCt=0-240 min) between Nortase and Kreon + Nortase (Add-On)
    - Comparison of the total 13CO2-emission data (AUCt=0-240 min) between Nortase and Kreon + PPI (acid resistance)
    - Comparison of the total 13CO2-emission data (AUCt=0-240 min) between Kreon and Kreon + PPI (acid resistance)
    - Comparison of the total 13CO2-emission data (AUCt=0-240 min) between Kreon and Kreon + Nortase (Add-On)
    - Comparison of the total 13CO2-emission data (AUCt=0-240 min) between Kreon + PPI and Kreon + Nortase
    - Comparison of the time until the first measurable 13CO2-signal (t1) occurs in the respective treatment groups
    - Comparison of the time to reach the maximum lipase activity (tmax) in the respective treatment groups
    - Comparison of the maximum lipase activity (vmax) of each administered therapy in the respective treatment groups.

    Safety and Tolerability
    - Type, frequency and severity of documented AEs and SAEs
    - Tolerability of the study medication (assessed by the subject)
    - Vergleich der Gesamt-13CO2-Emmission (AUCt=0-240 min) zwischen Nortase und Kreon + Nortase (Add-On)
    - Vergleich der Gesamt-13CO2-Emmission (AUCt=0-240 min) zwischen Nortase und Kreon + PPI (Säurefestigkeit)
    - Vergleich der Gesamt-13CO2-Emmission (AUCt=0-240 min) zwischen Kreon und Kreon + PPI (Säurefestigkeit)
    - Vergleich der Gesamt-13CO2-Emmission (AUCt=0-240 min) zwischen Kreon und Kreon + Nortase (Add-On)
    - Vergleich der Gesamt-13CO2-Emmission (AUCt=0-240 min) zwischen Kreon + PPI und Kreon + Nortase
    - Vergleich der Zeit bis zum ersten messbaren 13CO2-Signal (t1) in den jeweiligen Behandlungsgruppen
    - Vergleich der Zeit bis zum Erreichen der maximalen Lipaseaktivität (tmax) in den jeweiligen Behandlungsgruppen
    - Vergleich der maximalen Lipaseaktivität (vmax) in den jeweiligen Behandlungsgruppen
    E.5.2.1Timepoint(s) of evaluation of this end point
    These secondary endpoints will be analysed in accordance with the primary endpoint. Safety data will be analysed descriptively.
    Die sekundären Endpunkte werden im Zusammenhang mit dem primären Endpunkt analysiert. Sicherheitsdaten werden einer deskriptiven Analyse unterzogen.
    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 No
    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 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 Yes
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    prospektive Pilotstudie
    prospective pilot study
    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 trial4
    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 concerned2
    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
    Final visit of CRA at study site of LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years6
    E.8.9.1In the Member State concerned months8
    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: 20
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 4
    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 state24
    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)
    The patients are offered to discuss an intended treatment with the investigator at the study site after finishing the clinical study.
    Generell besteht für alle Patienten die Möglichkeit, nach Beendigung der Teilnahme an der klinischen Prüfung, soweit erforderlich, individuell nach Maßgabe des sie betreuenden Arztes weiter behandelt zu werden.
    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 Decision2017-04-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-05-08
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2023-06-22
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