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    Summary
    EudraCT Number:2014-003546-27
    Sponsor's Protocol Code Number:MED1-201308
    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:2016-02-02
    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 number2014-003546-27
    A.3Full title of the trial
    Chromoendoscopy versus conventional endoscopy in Patients with polyposis syndrome
    Chromoendoskopie versus konventionelle Endoskopie bei Patienten mit Polyposis-Erkrankungen
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Chromoendoscopy versus conventional endoscopy in Patients with polyposis syndrome
    Chromoendoskopie versus konventionelle Endoskopie bei Patienten mit Polyposis-Erkrankungen
    A.3.2Name or abbreviated title of the trial where available
    ChroPol
    A.4.1Sponsor's protocol code numberMED1-201308
    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 SponsorUniversitätsklinikum Bonn
    B.1.3.4CountryGermany
    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 supportBONFOR
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationStudienzentrale SZB
    B.5.2Functional name of contact pointDr. med. Christoph Coch
    B.5.3 Address:
    B.5.3.1Street AddressSigmund-Freud-Str .25
    B.5.3.2Town/ cityBonn
    B.5.3.3Post code53127
    B.5.3.4CountryGermany
    B.5.4Telephone number004922828716040
    B.5.5Fax number004922828716039
    B.5.6E-mailStudienzentrale-SZB@ukb.uni-bonn.de
    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 Indigocarmin Amino
    D.2.1.1.2Name of the Marketing Authorisation holderAmino AG
    D.2.1.2Country which granted the Marketing AuthorisationSwitzerland
    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 nameIndigocarmin Amino
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPGastroenteral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNIndigocarmin
    D.3.9.1CAS number 860-22-0
    D.3.9.3Other descriptive nameINDIGO CARMINE
    D.3.9.4EV Substance CodeSUB12518MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number4
    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
    Familial adenomatous polyposis
    Familäre adenomatöse Polyposis
    E.1.1.1Medical condition in easily understood language
    Vererbbare Erkrankung, die durch das Auftreten einer großen Anzahl von Polypen im Dickdarm gekennzeichnet ist.
    E.1.1.2Therapeutic area Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    E.1.2Level PT
    E.1.2Classification code 10056981
    E.1.2Term Adenomatous polyposis coli
    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
    Die Studie soll die Detektionsrate von Adenomen im Gastrointestinaltrakt durch Gebrauch der Chromoendoskopie mit Indigokarmin im Vergleich zu konventioneller Endoskopie bei Patienten mit Polyposis Erkrankungen untersuchen
    E.2.2Secondary objectives of the trial
    - Der Nachweis einer erhöhten Detektionsrate von Karzinomen im oberen und unteren Gastrointestinaltrakt durch den Gebrauch der Chromoendoskopie mit 0,4% Indigokarmin bei Patienten mit FAP oder MAP.
    - Der Nachweis einer erhöhten Detektionsrate an hyperplastischen Polypen im oberen und unteren Gastrointestinaltrakt durch den Gebrauch der Chromoendoskopie mit 0,4% Indigokarmin bei Patienten mit FAP oder MAP.
    - Nachweis der Sicherheit des Prüfpräparates.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Patienten müssen ≥ 18 Jahre alt sein
    - Schriftliche Einwilligung zur Teilnahme an der Studie
    - Fähigkeit und Bereitschaft die Studienanweisungen zu befolgen und alle erforderlichen Studienvisiten einzuhalten werden (Compliance)
    - Diagnose einer Polyposis, entweder bei familiärer adenomatöser Polyposis mit Nachweis einer pathogenen Mutation im APC-Gen oder
    Nachweis eines klassischen Phänotyps mit >100 Polypen im Kolon oder Nachweis einer pathogenen Mutation im MUTYH-Gen
    - Notwendigkeit zur diagnostischen Ösophagogastroduodenoskopie bzw. Koloskopie (MAP), Rektoskopie (FAP) oder Pouchoskopie
    - Negativer Schwangerschaftstest (β-HCG Test im Urin) bei gebärfahigen Patientinnen
    - Quick >50%
    - Thrombozyten >50.000 G/l
    E.4Principal exclusion criteria
    - Bekannte Allergie gegen das Prüfpräparat oder gegen Präparate mit ähnlicher chemischer Struktur
    - Unfähigkeit, die Bedeutung und die Konsequenzen dieser klinischen Prüfung zu verstehen
    - Gleichzeitige Teilnahme an einer klinischen Prüfung mit Einnahme eines Prüfpräparats bis zu 30 Tage vor Teilnahme an dieser klinischen Prüfung
    - Bekannter oder andauernder Missbrauch von Medikamenten, Drogen oder Alkohol
    - Vorliegende Schwangerschaft (positiver Schwangerschaftstest) oder Stillzeit
    - Verletzung der laborchemischen Einschlusskriterien
    - Patienten im schlechten Allgemeinzustand (> ASA III)
    - Bekanntes Lynch-Syndrom
    E.5 End points
    E.5.1Primary end point(s)
    Detektionsrate von Adenomen mittels Chromoendoskopie mit 0,4 % Indigokarmin im Vergleich zur konventionellen Endoskopie
    E.5.1.1Timepoint(s) of evaluation of this end point
    Monat 24 (Ende der Studie)
    E.5.2Secondary end point(s)
    - Anzahl von Karzinomen
    - Anzahl von hyperplastischen Polypen
    - Detektionsrate von Karzinomen mittels Chromoendoskopie mit Indigokarmin im Vergleich zur konventionellen Endoskopie
    - Detektionsrate von hyperplastischen Polypen mittels Chromoendoskopie mit Indigokarmin im Vergleich zur konventionellen Endoskopie
    - Auftreten von AEs und SAEs
    E.5.2.1Timepoint(s) of evaluation of this end point
    Monat 24 (Ende der Studie)
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Yes
    E.6.2Prophylaxis Yes
    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 No
    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 Yes
    E.8.2.3.1Comparator description
    konventionelle Endoskopie
    E.8.2.4Number of treatment arms in the trial1
    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 years2
    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: 70
    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 Yes
    F.3.3.1Women of childbearing potential not using contraception For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2016-02-02. Yes
    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 state88
    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)
    Nach Abschluss der klinischen Prüfung werden die Patienten, abhängig von im Rahmen der Studie aufgefallener pathologischer Veränderungen, entsprechend der klinischen Routine weiterbetreut.
    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 Decision2016-07-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-02-29
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2017-12-19
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