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    The EU Clinical Trials Register currently displays   37978   clinical trials with a EudraCT protocol, of which   6230   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2009-010727-91
    Sponsor's Protocol Code Number:00695
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2012-06-05
    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 number2009-010727-91
    A.3Full title of the trial
    Colesevelam for the treatment of bile acid malabsorption in patients with Crohn’s disease (Colesevelam für die Therapie der Gallensäuren-Malabsorption bei M. Crohn-Patienten)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Colesevelam, which is a medication which binds bile acid, to test in patients with Crohns disease
    A.4.1Sponsor's protocol code number00695
    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 SponsorLMU München, Campus Großhadern
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 Cholestagel
    D.2.1.1.2Name of the Marketing Authorisation holderGenzyme Ireland Ltd., IDA Industrial Park, Old Kil-meaden Road, Wa-terford, Irland
    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 nameCholestagel
    D.3.2Product code EU/1/03/268/002
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 INNColesevelam
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number625
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCoated tablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Morbus Crohn
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10011401
    E.1.2Term Crohn's disease
    E.1.2System Organ Class 10017947 - Gastrointestinal disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Reduktion der Frequenz flüssige/breiiger Stuhlgänge/Tag bei Patienten mit Gallensäureverlustsyndrom
    E.2.2Secondary objectives of the trial
    Besserung der Stuhlkonsistenz (Bristol stool chart), Lebensqualität, Sicherheit der Prüfmedikation
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Schriftliche Einwilligung des Patienten nach erfolgter Aufklärung
    • Männliche und weibliche Patienten mit Morbus Crohn im Alter von 18 bis 65 Jahren in Remission (CDAI-Wert ≤ 150), die Symptome einer funktionellen Gallensäuren-Malabsorption bzw. Symptome einer Gallen-säuren-Malabsorption nach Dünndarmresektion haben (≥ 3 und ≤ 15 flüssigen/breiigen Stuhlgänge/Tag)
    • Begleitende/Vorbestehende orale Medikation entweder mit Aminosalicylaten, Steroiden (<10 mg/Tag), Aza-thioprin, 6-Mercaptopurin, Methotrexat oder TNF-alpha AK (Infliximab, Adalimumab, Certolizumab) in stabiler Dosierung für mindestens 3 Monate vor Einschluss
    • CRP-Wert im Serum ≤ 1.0 mg/dL
    • Gallensäuren-Malabsorption bestätigt mittels 7α-Hydroxy-4-cholesten-3-on-Wert-Bestimmung im Serum ≥ 50 ng/ml
    E.4Principal exclusion criteria
    • Anamnestisch bekannte Überempfindlichkeit gegenüber dem eingesetzten Prüfpräparat
    • Teilnahme des Patienten an einer anderen klinischen Studie innerhalb der letzten 4 Wochen vor dem Ein-schluss
    • Sucht- oder sonstige Erkrankungen, die es dem Betreffenden nicht erlauben, Wesen und Tragweite sowie mögliche Folgen der klinischen Prüfung abzuschätzen
    • Anzeichen darauf, dass der Patient den Prüfplan voraussichtlich nicht einhalten wird (z. B. mangelnde Ko-operationsbereitschaft)
    • Cyclosporin- oder Tacrolimus-Therapie bis 12 Wochen vor Einschluss
    • Einnahme von Antibiotika bis 3 Wochen vor Einschluss
    • Topische Therapie mit Steroid- oder Mesalazin-Präparaten bis 3 Wochen vor Einschluss
    • Therapie mit einem gallensäurebindenden Medikament bis 6 Wochen vor Einschluss
    • Infektionserkrankungen (HIV, Hepatitis B, Hepatitis C, Tuberkulose, Listeriose, positiver Clostridium-difficile-Toxin-Nachweis im Stuhl)
    • Intraabdomineller Abszess
    • Fistel
    • Schwere Nieren- oder Lebererkrankung
    • Dysphagie oder Schluckschwierigkeiten
    • Cholestatische Lebererkrankung
    • Bekanntes Malignom oder Malignom in der Vorgeschichte
    • Zustand nach Darmoperation bis 6 Monate vor Einschluss
    • Zustand nach Darmoperation mit >100 cm entferntem Darmanteil
    • Kurzdarm-Syndrom
    • Vorhandensein eines Stomas
    • Schwangerschaft und StillzeitEinnahme von Antibiotika bis 3 Wochen vor Einschluss
    • Orale und topische Therapie mit Steroid- oder Mesalazin-Präparaten bis 3 Wochen vor Einschluss
    • Infektionserkrankungen (HIV, Hepatitis B, Hepatitis C, Tuberkulose, Listeriose, positiver Clostridium-difficile-Toxin-Nachweis im Stuhl)
    • Intraabdomineller Abszess
    • Darmstenosen
    • Fistel
    • Schwere Nieren- oder Lebererkrankung
    • Cholestatische Lebererkrankung
    • Bekanntes Malignom oder Malignom in der Vorgeschichte
    • Zustand nach Darmoperation bis 6 Monate vor Einschluss
    • Zustand nach Darmoperation mit >100 cm entferntem Darmanteil
    • Kurzdarm-Syndrom
    • Stoma
    • Schwangerschaft und Stillzeit
    E.5 End points
    E.5.1Primary end point(s)
    Anteil von Probanden pro Therapiegruppe im Vergleich zu Placebo, bei denen es zu einer signifikanten Ver-bessserung der Stuhlfrequenz, definiert als >30 % Reduktion flüssiger/breiiger Stuhlgänge pro Tag im Vergleich zu Baseline nach 4 Wochen kommt
    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) 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 No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    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 Yes
    E.8.2.3Other No
    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 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 Information not present in EudraCT
    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
    Ende der Studie, wenn alle 50 Patienten Woche 4 abgeschlossen haben.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    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: 50
    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 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 2012-06-05. 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 state50
    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 Decision2011-03-01
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-12-03
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2013-02-28
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