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    Summary
    EudraCT Number:2019-002762-12
    Sponsor's Protocol Code Number:SJ-674
    National Competent Authority:Denmark - DHMA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2019-07-25
    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 ConcernedDenmark - DHMA
    A.2EudraCT number2019-002762-12
    A.3Full title of the trial
    The prevalence of bile acid diarrhéa and the effect of budesonid on the bile acid homeostasis in patients with microscopic colitis
    Prævalens af galdesyrediarré og effekt af budesonid på galdesyrehomeostasen hos patienter med mikroskopisk colitis
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    The prevalence of bile acid diarrhéa and the effect of treatment in patients with microscopic colitis
    A.4.1Sponsor's protocol code numberSJ-674
    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 SponsorZealand University Hospital
    B.1.3.4CountryDenmark
    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 supportRegion Sjællands Sundhedsvidenskabelige Forskningsfond
    B.4.2CountryDenmark
    B.4.1Name of organisation providing supportTillotts Pharma AG
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationZealand University Hospital
    B.5.2Functional name of contact pointDepartment of Medicine
    B.5.3 Address:
    B.5.3.1Street AddressLykkebækvej 1
    B.5.3.2Town/ cityKøge
    B.5.3.3Post code4600
    B.5.3.4CountryDenmark
    B.5.6E-mailrubenlorentsen@hotmail.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 Entocort
    D.2.1.1.2Name of the Marketing Authorisation holderTillotts Pharma AB
    D.2.1.2Country which granted the Marketing AuthorisationDenmark
    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 nameEntocort
    D.3.4Pharmaceutical form Modified-release 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 INNBUDESONIDE
    D.3.9.1CAS number 51333-22-3
    D.3.9.4EV Substance CodeSUB05955MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number9
    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
    Microscopic colitis
    Bile acid diarrhea
    Mikroskopisk colitis
    Galdesyrediarré
    E.1.1.1Medical condition in easily understood language
    Microscopic colitis is a chronic type of diarrhea with inflammation of the large colon, only seen microscopically. The causes of inflammation is unknown, but bile acids seem to play a role.
    Mikroskopisk colitis er en kronisk form for diarré med betændelse af tyktarmen, som kun kan ses ved mikroskopi. Årsagerne til betændelsen er ukendte, men galdesyre ser ud til at spille en rolle.
    E.1.1.2Therapeutic area Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]
    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 investigate the prevalence of bile acid diarrhea (BAD) in patients with active microscopic colitis (MC). The apperance of BAD is defined by watery stools and a raised level of 7alpha-hydroxy-4-cholesten-3-on (C4).
    E.2.2Secondary objectives of the trial
    To investigate the effect of budesonide on the bile acid homeostasis assessed by changes in C4 and FGF19
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Suspected activity in MC, defined by Hjortswang criteria: 3 stools daily OR one watery (Bristol type 6or7) stools daily, as a mean over the last 6-7 days.
    Proven microscopic colitis (collagenous, lymphocytic or incomplete) in biopsies from the last 6 years
    E.4Principal exclusion criteria
    Age < 18 years
    Stoma
    Pregnancy
    Intestinal resection other than appendectomy
    cholecystectomy
    Other chronic intestinal disease with diarrhoea
    Use of other constipation agent than loperamide
    Systemic treatment with steroid within 2 weeks of the start of treatment
    Suspected or proven gastrointestinal infection
    Allergy to budesonide
    Lack of compliance or understanding of the trial
    If taking statin or fibrate therapy: unwilling to pause medical treatment against hypercholesterolaemia
    E.5 End points
    E.5.1Primary end point(s)
    Prevalence of BAD defined by fasting C4 levels > 46 ng/mL in patients with active MC
    E.5.1.1Timepoint(s) of evaluation of this end point
    Analysis of the biobank blood samples after LSLV. Expected aprox. medio 2022
    E.5.2Secondary end point(s)
    Prevalence of BAD defined by total bile acids > 16 mikromol/g
    Effect of budesonide on Bile acid diarrhoea as defined above; comparison of prevalence of BAD week 1 and 6.
    Changes from week 1 (baseline), week 6 (during tratment) and week10 (after treatment) analysed with randomised mixed model:
    1. Changes in biomarkers C4, FGF19, total bile acids in spot faecal sample, fractin of primary bile acids in spot faecal sample.
    2. Differences between groups MC +BAD and MC - BAD in (a) total bowel movement (week 1,6,10), (b) treatment effect according to modified Hjrotswang criteria, (c) rate of relapse week 6 and 10, (d) changes in HRQol from week 1 to 6: SHS question 1 and 2 and total SHS respectively, (e) GIQLI sum of diarrhoea related questions (item 30,31,36), (f) estimated prevalence of BAD in MC calculated from the sensitivity of C4 as compared with SeHCAT.
    Prevalence of BAD defined by fasting FGF19 levels < 60 pg/mL in patients with active MC
    Prevalence of BAD in each of the MC subtypes defined by fasting C4 levels > 30 ng/mL in patients with active MC
    Difference in levels of C4 in week 0, 6, and 10
    Difference in levels of FGF19 in week 0, 6, and 10
    Correlation between difference in C4 and difference in activity
    Difference in groups with MC with and without BAD with regards to numbers of stools, treatment effects and quality of life index
    Changes in fractions of primary bile acids in stools (week 0, 6, and 10)
    E.5.2.1Timepoint(s) of evaluation of this end point
    Analysis of the biobank blood samples after LSLV. Expected aprox. medio 2023
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Yes
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety No
    E.6.5Efficacy No
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic Yes
    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 No
    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 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 concerned5
    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 years3
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    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: 25
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 29
    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 state54
    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 planned
    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 Decision2019-09-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-12-07
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2023-09-23
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