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    Summary
    EudraCT Number:2016-001921-15
    Sponsor's Protocol Code Number:BUS-4/UCA
    National Competent Authority:Poland - Office for Medicinal Products
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2017-03-17
    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 ConcernedPoland - Office for Medicinal Products
    A.2EudraCT number2016-001921-15
    A.3Full title of the trial
    Randomised, double-blind, double-dummy, multicentre study to compare the efficacy and safety of once daily novel 4 mg budesonide suppository versus once daily 2 mg budesonide foam in patients with acute ulcerative proctitis
    Randomizowane, podwójnie ślepe, podwójnie pozorowane, wieloośrodkowe badanie w celu porównania skuteczności i bezpieczeństwa nowego budezonidu 4 mg stosowanego raz dziennie w postaci czopków, w porównaniu z budezonidem 2 mg stosowanym raz dziennie w postaci pianki doodbytniczej, u pacjentów z ostrym wrzodziejącym zapaleniem odbytnicy
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Novel budesonide suppository vs. budesonide foam in acute ulcerative proctitis.
    Nowy budezonid w postaci czopka w porównaniu z budezonidem w postaci pianki w ostrym wrzodziejącym zapaleniu odbytnicy
    A.3.2Name or abbreviated title of the trial where available
    Novel budesonide suppository vs. budesonide foam in acute ulcerative proctitis.
    A.4.1Sponsor's protocol code numberBUS-4/UCA
    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 SponsorDr. Falk Pharma 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 supportDr. Falk Pharma GmbH
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationDr. Falk Pharma GmbH
    B.5.2Functional name of contact pointDept. of Clinical Research & Develo
    B.5.3 Address:
    B.5.3.1Street AddressLeinenweberstrasse 5
    B.5.3.2Town/ cityFreiburg
    B.5.3.3Post code79108
    B.5.3.4CountryGermany
    B.5.4Telephone number+497611514156
    B.5.5Fax number+497611514377
    B.5.6E-mailmohrbacher@drfalkpharma.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 No
    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 nameBudenofalk® suppositories (BUS)
    D.3.4Pharmaceutical form Suppository
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPRectal 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.3.9.3Other descriptive nameBudenofalk® suppositories (BUS)
    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 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.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 Budenofalk rectal foam
    D.2.1.1.2Name of the Marketing Authorisation holderDr. Falk Pharma 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 nameBudenofalk rectal foam
    D.3.4Pharmaceutical form Rectal foam
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPRectal 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.3.9.2Current sponsor codeBudenofalk Rectal Foam
    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 number2
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSuppository
    D.8.4Route of administration of the placeboRectal use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboRectal foam
    D.8.4Route of administration of the placeboRectal use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Acute Ulcerative Proctitis
    Ostre wrzodziejące zapalenie odbytnicy
    E.1.1.1Medical condition in easily understood language
    Acute Ulcerative Proctitis - Inflammation of the Rectum
    Ostre wrzodziejące zapalenie odbytnicy - zapalenie odbytnicy
    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 20.1
    E.1.2Level LLT
    E.1.2Classification code 10045368
    E.1.2Term Ulcerative proctitis
    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
    To prove the non-inferiority of an 8-week treatment with once-daily 4 mg budesonide suppository vs. active comparator 2 mg budesonide foam in patients with acute ulcerative proctitis.
    Udowodnienie nie mniejszej skuteczności 8 tygodniowego leczenia raz dziennie budezonidem 4 mg w postaci czopków w porównaniu z aktywnym komparatorem budezonidem 2 mg w postaci pianki, u pacjentów z ostrym wrzodziejącym zapaleniem odbytnicy.
    E.2.2Secondary objectives of the trial
    - To assess safety and tolerability in the form of adverse events and laboratory parameters,
    - To assess patients' acceptance and preference of the investigational medicinal products.
    - ocena bezpieczeństwa i tolerancji poprzez zdarzenia niepożądane i parametry laboratoryjne
    - ocena akceptacji i preferencji pacjentów odnośnie leków badanych
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Man or woman between 18 and 75 years of age,
    - Acute ulcerative proctitis,
    - Diagnosis confirmed by total colonoscopy or flexible sigmoidoscopy
    - New diagnosis or established disease
    - Mildly to moderately active ulcerative proctitis (3 < modified UC-DAI < 11) with rectal bleeding subscore of ≥ 1 and endoscopic subscore of ≥ 2,
    - Mężczyzna lub kobieta w wieku 18-75 lat
    - Ostre wrzodziejące zapalenie odbytnicy
    - Diagnoza potwierdzona pełną kolonoskopią lub sigmoidoskopią giętką
    - Nowe rozpoznanie lub rozpoznana choroba
    - Łagodne do umiarkowanego aktywne zapalenie odbytnicy (3 < zmodyfikowane UC-DAI < 11) z wynikiem cząstkowym dotyczącym krwawienia odbytniczego ≥ 1 oraz z wynikiem cząstkowym dotyczącym parametru endoskopowego ≥ 2
    E.4Principal exclusion criteria
    - Crohn’s disease, indeterminate colitis, ischemic colitis, diverticular associated colitis, microscopic colitis,
    - Presence of proctitis of a different origin (e.g. infectious or parasitic, drug-induced),
    - Previous colonic surgery (except appendectomy, haemorrhoidectomy, and endoscopic removal of polyps),
    - Presence of symptomatic organic disease of the gastrointestinal tract (with the exception of non-bleeding haemorrhoids or hiatal hernia),
    - Local intestinal infection (i.e. pathogenic bacteria or Clostridium difficile toxin in stool culture),
    - Oral/rectal/intravenous corticosteroids therapy within the last 4 weeks prior to baseline,
    - Existing or intended pregnancy or breast-feeding,
    - Participation in another clinical trial and having received IMP within the last 30 days prior to screening or within 5-half-lives of IMP (whichever is longer), simultaneous participation in another clinical trial, or previous participation in this trial and having received IMP.
    - Choroba Leśniowskiego-Crohna, nieokreślone zapalenie jelita grubego, niedokrwienne zapalenie jelita grubego, zapalenie jelita grubego związane z uchyłkowatością, mikroskopowe zapalenie jelita grubego
    - Zapalenie odbytnicy innego pochodzenia (np. zakaźne lub pasożytnicze, wywołane lekami)
    - Wcześniejsza operacja jelita grubego (z wyjątkiem appendektomii, hemoroidektomii i endoskopowego usunięcia polipów)
    - Obecność objawowej, organicznej choroby przewodu pokarmowego
    (za wyjątkiem nie krwawiących hemoroidów lub przepukliny rozworu przełykowego)
    - Miejscowe zakażenie jelita (tj. wywołane bakteriami patogennymi lub obecnością toksyn bakterii Clostridium difficile w wynikach posiewu kału)
    - Doustne/doodbytnicze/dożylne leczenie kortykosteroidami w okresie ostatnich 4 tygodni przed baseline
    - Trwająca lub planowana ciąża albo karmienie piersią
    - Udział w innym badaniu klinicznym i otrzymanie leku badanego w okresie ostatnich 30 dni przed skriningiem lub w czasie 5 okresów półtrwania leku badanego (który jest dłuższy), jednoczesny udział w innym badaniu klinicznym lub wcześniejszy udział w tym badaniu i otrzymanie leku badanego
    E.5 End points
    E.5.1Primary end point(s)
    - Rate of clinical remission
    - Rate of mucosal healing
    - Wskaźnik klinicznej remisji
    - Wskaźnik wygojenia błony śluzowej
    E.5.1.1Timepoint(s) of evaluation of this end point
    After 8 weeks of treatment
    Po 8 tygodniach leczenia
    E.5.2Secondary end point(s)
    - Rate of patients with clinical remission
    - Rate of patients with mucosal healing
    - Time to resolution of clinical symptoms
    - Wskaźnik pacjentów z kliniczną remisją
    - Wskaźnik pacjentów z wygojeniem błony śluzowej
    - Czas po ustąpieniu objawów klinicznych
    E.5.2.1Timepoint(s) of evaluation of this end point
    After 8 weeks of treatment
    Po 8 tygodniach leczenia
    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 Yes
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    Podwójnie pozorowane
    Double Dummy
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo Yes
    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 concerned11
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA29
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Germany
    Hungary
    Latvia
    Poland
    Russian Federation
    Slovakia
    Ukraine
    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
    LVLS
    Ostatnia Wizyta Ostatniego Pacjenta
    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
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial 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: 519
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 57
    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 state110
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 150
    F.4.2.2In the whole clinical trial 576
    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)
    Once a patient has completed participation in the study they will be treated as per Standard medical practice for this Patient population
    Po zakończeniu udziału w badaniu pacjenci będą leczeni zgodnie ze standardową opieką medyczną dla tej populacji pacjentów.
    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 Decision2017-05-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-03-30
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2020-03-30
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