This will be a multicentre, randomised, double-blind, double-dummy, parallel group
comparative study in patients with mild or moderate, active ulcerative colitis. The study
will compare budesonide-MMX™ 6 mg and budesonide-MMX™ 9 mg tablets to placebo and to
Entocort® 3 x 3 mg capsules, in four parallel groups of patients over an 8 week treatment
period.
After the screening visit, patients will enter a washout period of 2 days, then they will be
randomised to the following four treatment groups: budesonide-MMX™ tablets (6 mg),
budesonide-MMX™ tablets (9 mg), Entocort® capsules (3 x 3 mg) and placebo (tablets and
capsules), all administered once a day after breakfast. Hence, each patient will receive, in
the morning after breakfast, either one budesonide-MMX™ 6 mg or budesonide MMX™ 9 mg tablet
and 3 placebo Entocort® matching capsules, or three Entocort® 3 mg capsules and one placebo
budesonide-MMX™ matching tablet, or one placebo budesonide-MMX™ matching tablet and three
placebo Entocort® matching capsules.
Inclusion Criteria:
- Patients fulfilling the following criteria at the screening visit are eligible for
participation in the study:
- Male and female patients, 18-75 years old, suffering from ulcerative colitis for
at least 6 months.
- Diagnosis of ulcerative colitis in active phase, of mild or moderate entity with
Ulcerative Colitis Disease Activity Index (UCDAI) ≥ 4 and ≤ 10 according to
Sutherland.
- All females of child-bearing potential must have a negative serum pregnancy test
immediately prior to enrollment. In addition, all females of child-bearing
potential must agree to be completely abstinent or be using an accepted form of
contraception throughout the entire study period. Accepted forms of
contraception are defined as those with a failure rate <1% when properly applied
and include: combination oral pill, some intra-uterine devices, and a sterilised
partner in a stable relationship. Female subjects must also not be actively
breast-feeding through the entire study period.
- Ability to comprehend the full nature and purpose of the study, including
possible risks and side effects.
- Ability to co-operate with the investigator and to comply with the requirements
of the entire study.
- Must be able to understand and voluntarily sign written informed consent prior
to inclusion in the study.
Exclusion Criteria:
- Patients who meet any of the following criteria at screening visit are to be excluded
from study participation:
- Patients with limited distal proctitis (from anal verge up to 15 cm above the
pectineal line).
- Patients with severe ulcerative colitis (UCDAI >10).
- Patients with infectious colitis.
- Evidence or history of toxic megacolon.
- Severe anaemia, leucopaenia or granulocytopaenia.
- Use of oral or rectal steroids in the last 4 weeks.
- Use of immuno-suppressive agents in the last 8 weeks before the study.
- Use of anti tumour necrosis factor alpha (anti-TNFα) agents in the last 3
months.
- Concomitant use of any rectal preparation.
- Concomitant use of antibiotics.
- Concurrent use of CYP3A4 inducers or CYP3A4 inhibitors. See Section 4. 2, Table 5
for complete list.
- Patients with verified, presumed or expected pregnancy or ongoing lactation.
- Patients with liver cirrhosis, or evident hepatic or renal disease or
insufficiency, and/or severe impairment of the bio-humoural parameters (i. e. 2 x
upper limit of normal for ALT, AST, GGT or creatinine).
- Patient with severe diseases in other organs and systems.
- Patients with local or systemic complications or other pathological states
requiring a therapy with corticosteroids and/or immuno-suppressive agents.
- Patients diagnosed with type 1 diabetes.
- Patients diagnosed with, or with a family history of, glaucoma.
- All patients with known hepatitis B, hepatitis C or with human immunodeficiency
virus (HIV), according to the local privacy policy.
- Participation in experimental therapeutic studies in the last 3 months. (Note:
patients who participated in observational only studies are not excluded).
- Any other medical condition that in the principal investigator's opinion would
make the administration of the study drug or study procedures hazardous to the
subject or obscure the interpretation of adverse events (AEs).
Desirée Richold, Phone: +44 (0) 1256 460090, Email: desiree.richold@iconplc.com
Royal Adelaide Hospital, Adelaide 5000, Australia; Recruiting
David Hetzel, Phone: +61(0)8 8210 9491, Email: david.hetzel@health.sa.gov.au
David Hetzel, Principal Investigator
Monash Medical Centre, Melbourne 3168, Australia; Recruiting
Gregory Moore, Phone: +61 3 9594 3177, Email: Greg.Moore@med.monash.edu.au
Gregory Moore, Principal Investigator
Box Hill Hospital, Department of Gastroenterology Clive Ward Centre,, Box Hill VIC 3128, Australia; Recruiting
Peter Gibson, Phone: +61 (0)3 9895 0369, Email: miles.Sparrow@med.monash.edu.au
Peter Gibson, Principal Investigator
The Alfred Hospital, Melbourne 3004, Australia; Recruiting
Simon Jakobovits, Phone: +61 (0)3 9276 3375, Email: s.jakobovits@alfred.org.au
Simon Jakobovits, Principal Investigator
Imelda Hospital, Bonheiden, Belgium; Recruiting
Gert D'Haens, Phone: +32 15 505 161
East Viru Central Hospital, Kohtla-Jarve 30322, Estonia; Recruiting
Jaak Lind, Phone: +372 50 31 255, Email: Jaak.Lind@ivkh.ee
Jaak Lind, Principal Investigator
West Tallinn Central Hospital, Tallinn 10617, Estonia; Recruiting
Anu Maelt, Phone: +372 518 66 43, Email: anu.maelt@gmail.com
Anu Maelt, Principal Investigator
East Tallinn Central Hospital, Tallinn 10138, Estonia; Recruiting
Benno Margus, Phone: +372 6207 071, Email: benno.margus@itk.ee
Benno Margus, Principal Investigator
Tartu University Hospital, Tartu 51014, Estonia; Recruiting
Riina Salupere, Phone: +372 53318658, Email: riina.salupere@kliinikum.ee
Riina Salupere, Principal Investigator
Hôpital Beaujon, Clichy Cedex, France; Recruiting
Yoram Bouhnik, Phone: 331 40 87 56 16, Email: yoram.bouhnik@bjn.aphp.fr
Yoram Bouhnik, Principal Investigator
Hospital Saint-Louis, Paris, France; Recruiting
Marc Leman, Phone: 33142499597, Email: marc@lemann.com
Marc Leman, Principal Investigator
CRO - IRCCS - Struttura Operativa Complessa di Gastroenterologia Oncologica, Aviano 33081, Italy; Recruiting
Renato Cannizzaro, Phone: 0039 0434659281, Email: rcannizzaro@cro.it
Renato Cannizzaro, Principal Investigator
Dipartimento di Medicina Interna e Specialità Mediche (DIMI), Genova 16132, Italy; Recruiting
Edoardo Savarino, Phone: +39 010 3538956, Email: vsavarin@unige.it
Edoardo Savarino, Principal Investigator
Divisione di Gastroenterologia - Istituto Clinico Humanitas IRCCS in Gastroenterologia, Milan 20098, Italy; Recruiting
Silvio Danese, Phone: +39 02 82244771, Email: sdanese@hotmail.com
Silvio Danese, Principal Investigator
Daugavpils Regional Hospital, Daugavpils 5417, Latvia; Recruiting
Natalja Kakurina, Phone: +371 2 942 13 89, Email: nkbox@apollo.lv
Natalja Kakurina, Principal Investigator
Clinical University Hospital Gailezers, Riga 1038, Latvia; Recruiting
Diana Lisova, Phone: +371 2985 6753, Email: dianalisova@inbox.lv
Diana Lisova, Principal Investigator
Paula Stradina Clinical University Hospital, Riga 1002, Latvia; Recruiting
Juris Pokrotnieks, Phone: +371 2924 5244, Email: pokrot@latnet.lv
Juris Pokrotnieks, Principal Investigator
Digestive Disease Centre Gastro, Riga 1006, Latvia; Recruiting
Ivars Tolmanis, Phone: +371 2924 5443, Email: tolmanis@linezers.riga.lv
Ivars Tolmanis, Principal Investigator
Siauliai District Hospital, Siauliai 76231, Lithuania; Recruiting
Gitana Acute, Phone: +370 6854 5102, Email: agitana@splius.lt
Gitana Acute, Principal Investigator
Vilnius University Hospital Santariskiu Klinikos, Vilnius 08661, Lithuania; Recruiting
Edita Kazenaite, Phone: +370 6882 5454, Email: Edita.Kazenaite@mf.vu.lt
Edita Kazenaite, Principal Investigator
Kaunas Medical University Hospital, Kaunas 50009, Lithuania; Recruiting
Limas Kupcinskas, Phone: +370 6856 8861
Limas Kupcinska, Principal Investigator
M.Marcinkeviciaus Hospital, Vilnius 03215, Lithuania; Recruiting
Raimonda Vanagaitiene, Phone: +370 6864 1011, Email: nevieraraima@yahoo.com
Raimonda Vanagaitiene, Principal Investigator
NZOZ Centrum Leczenia Chorob Cywilizacyjnych, Gdynia 81-572, Poland; Recruiting
Anna Drobińska-Jurowiecka, Email: fikakowo@clcc.pl
Anna Drobińska-Jurowiecka, Principal Investigator
NZOZ Polimedica, Łódź 90-302, Poland; Recruiting
Oset, Phone: +48 42 6365574, Email: poset@op.pl
Oset, Principal Investigator
Indywidualna Specjalistyczna Praktyka Lekarska, Wejherowo 84-200, Poland; Recruiting
Andrzej Dubaniewicz, Phone: +48 58 5727444, Email: adubaniewicz@onet.eu
Andrzej Dubaniewicz, Principal Investigator
Szpital Uniwersytecki w Krakowie,Oddział Kliniczny Kliniki Gastroenterologii Hematologii i Chorób Zakaźnych, Kraków 31-531, Poland; Recruiting
Irena Ciecko-Michalska, Phone: +48 12 4247382, Email: michalska@su.krakow.pl
Irena Ciecko-Michalska, Principal Investigator
Endoskopia Sp.z o.o., Sopot 81-756, Poland; Recruiting
Marek Hoyrnski, Phone: +48 58 5501473, Email: badanie.kliniczne@wp.pl
Marek Hoyrnski, Principal Investigator
Gastromed S.C.Maciej Kralisz, Andrzej Penpicki, Jacek Romatowski, Gabinet, Gastrologiczny i Pracownia Endoskopowa, Bialystok 15-842, Poland; Recruiting
Jacek Romatowski, Phone: +48 85 654 53 53, Email: jromatowski@wp.pl
Jacek Romatowski, Principal Investigator
NZOZ Centrum Leczenia Chorob Cywilizacyjnych, oddzial Gdynia, filia Fikakw, Gdynia 81-572, Poland; Recruiting
Anna Drobinska-Jurowiecka, Phone: +48 58 781 0811, Email: fikakowo@clcc.pl
Anna Drobinska-Jurowiecka, Principal Investigator
Niepubliczny Zaklad Opieki Zdrowotnej POLIMEDICA, Lodz 90-302, Poland; Recruiting
Robert Petryka, Phone: +48 42 631 04 56
Robert Petryka, Principal Investigator
Samodzielny Publiczny Zaklad Opieki Zdrowotnej, Szpital Uniwersytecki w Krakowie, Oddzial Kliniczny Kliniki Gastroenterologii, Hepatologii i Chorob Zakaznych,, Krakow 31-531, Poland; Recruiting
Irena Ciecko-Michalska, Phone: +48 503 577 488, Email: michalska@su.krakow.pl
Irena Ciecko-Michalska, Principal Investigator
Endoskopia Sp. z o.o., Sopot 81-756, Poland; Recruiting
Marek Hoyrnski, Phone: +48 501 011 879, Email: badanie.kliniczne@wp.pl
Marek Hoyrnski, Principal Investigator
Spitalul Clinic Colentina Sectia Gastroenterologie, Bucuresti 020125, Romania; Recruiting
Radu Voiosu, Phone: 40 723824795, Email: theodorv@b.astral.ro
Radu Voiosu, Principal Investigator
Spitalul Judetean Sibiu, Sibiu, Romania; Recruiting
Alexandru Fraticiu, Phone: 40728 051 716, Email: afraticiu@yahoo.com
Alexandru Fraticiu, Principal Investigator
Cabinet Medical, Oradea, Romania; Recruiting
Augustin Lenghel, Phone: 0040722 393 780, Email: augustinlenghel@yahoo.com
Augustin Lenghel, Principal Investigator
Centrul de Gastroenterologie Dr. Goldis Adrian, Timisoara, Romania; Recruiting
Adian Goldis, Phone: 0040722 410 712, Email: goldisadi@yahoo.com
Adian Goldis, Principal Investigator
Rostov State Medical University, Rostov-on-Don 344022, Russian Federation; Recruiting
Alexander Tkachev, Phone: +7 863 271 97 05, Email: tkachev@aaanet.ru
Alexander Tkachev, Principal Investigator
ZAO Clinic Dvizhenie, Volgograd 400107, Russian Federation; Recruiting
Oleg Solovyev, Phone: +7 8442485401, Email: dvizhenie@avtlg.ru
Oleg Solovyev, Principal Investigator
Yaroslavl Region Clinical Hospital, Yaroslavl, Russian Federation; Recruiting
Oleg Khrustalev, Email: khrust@okb.yar.ru
Oleg Khrustalev, Principal Investigator
State Scientific Centre of Coloproctology of the Federal Agency for High-Technology Medical Care, Moscow 123423, Russian Federation; Recruiting
Oleg Golovenko, Phone: +7 499 199 06 57, Email: drgolovenko@yandex.ru
Oleg Golovenko, Principal Investigator
GUZ of Moscow "City Clinical Hospital #24", Moscow 127006, Russian Federation; Recruiting
Mikhail Yurkov, Phone: 7 495 685 6832, Email: yurkov_52@mail.ru
Yurkov Mikhail, Principal Investigator
Saint-Petersburg GUZ City polyclinic #38 28, St Petersburg 193015, Russian Federation; Recruiting
Boris Starostin, Phone: +7(812)2742906, Email: starostinbd@mail.ru
Boris Starostin, Principal Investigator
St. Petersburg State Medical Academy n.a. I.I. Mechnikov, St Petersburg, Russian Federation; Recruiting
Evgeny Tkachenko, Phone: +7 812 543 95 38, Email: avalueva@mail.ru
Evgeny Tkachenko, Principal Investigator
FGU North-West DIstrict Medical Center of Roszdrav, St-Petersburg 199004, Russian Federation; Recruiting
Rodion Oseshnyuk, Phone: +7 812 251 23 24, Email: rao81@mail.ru
Rodion Oseshnyuk, Principal Investigator
GU research educational medical centre of the administration of the affairs of the president of Russian Federation on the basis of State Healthcare Institution "State Clinical Hospital # 51", Moscow 121309, Russian Federation; Recruiting
Oleg Minushkin, Phone: +7 499 146 81 35
Oleg Minushkin, Principal Investigator
Krestovsky Ireland Medical Institute, St-Petersburg 197110, Russian Federation; Recruiting
Dmitry Volkov, Phone: +7 812 329 03 23, Email: volkovd@gminstitutes.ru
Dmitry Volkov, Principal Investigator
Federal State Institution ?National Medical Surgical Center, Moscow 105203, Russian Federation; Recruiting
Emilia Yakovenko, Phone: 7 495 464 39 63, Email: kafgastro@mail.ru
Emilia Yakovenko, Principal Investigator
Gastroenterologické a Hepatologické centrum, Nitra 94901, Slovakia; Recruiting
Milos Gregus, Phone: +421376545228, Email: ghugregus@gmail.com
Milos Gregus, Principal Investigator
NsP Nove Mesto nad Vahom n.o., Nové Mesto nad Váhom, Slovakia; Recruiting
Slavomir Cernok, Phone: +421327740330, Email: slavomir.cernok@nspnm.sk
Slavomir Cernok, Principal Investigator
FNsP Bratislava, Nemocnica Ruzinov V. Interna klinika, Gastroenterohepatologicke oddelenie Ruzinovska, Bratislava 826 06, Slovakia; Recruiting
Martin Huorka, Phone: +421248234770, Email: huorka@stonline.sk
Martin Huorka, Principal Investigator
FNsP Bratislava, Nemocnica Stare Mesto 1st Internal Clinic Mickiewiczova, Bratislava 813 69, Slovakia; Recruiting
Ludovit Lukac, Phone: +421257290503, Email: ludovit.lukac@centrum.sk
Ludovit Lukac, Principal Investigator
Lund University Hospital, Lund 221 85, Sweden; Recruiting
Erik Hertervig, Email: erik.hertervig@skane.se
Erik Hertervig, Principal Investigator
Dept. of Gastroenerology and Hepatology, Stockholm 171 76, Sweden; Recruiting
Ragnar Befrits, Phone: +46 8 5177 4130, Email: ragnar.befrits@karolinska.se
Ragnar Befrits, Principal Investigator
Div. of Gastroenterology and Hepatology, Stockholm 118 83, Sweden; Recruiting
Per Karlen, Email: per.karlen@sodersjukhuset.se
Per Karlen, Principal Investigator
Sahlgrenska Univerity Hospital, Göteborg 416 85, Sweden; Recruiting
Anders Eriksson, Phone: +46 31 343 5592, Email: anders.eriksson@vgregion.se
Anders Eriksson, Principal Investigator
IBD-Unit, Sophiahemmet, Stockholm 11486, Sweden; Recruiting
Robert Lofberg, Email: ibd@sophiahemmet.se
Robert Lofberg, Principal Investigator
Odessa city Polyclinic #20, Therapeutic Dept. 6, Odessa 65114, Ukraine; Recruiting
Zinaiida Telyatnikova, Phone: +380 048 746 03 17, Email: tze@mail.ru
Zinaiida Telyatnikova, Principal Investigator
Uzhgorod National University, Hospital surgery chair on the base of Uzhgorod Regional Clinical Hospital, Uzhorod, Ukraine; Recruiting
Rusin Vasyl, Phone: +3 80312613570, Email: rusinhirurg@gmail.com
Rusin Vasyl, Principal Investigator
Uzhgorod State Medical University, chair of therapy and family medicine, district clinical hospitalof station "Uzhgorod", Uzhorod, Ukraine; Recruiting
Ivan Chopey, Phone: +380312643834, Email: iv@chp.uzhgorod.ua
Ivan Chopey, Principal Investigator
City Clinical Emergency Hospital named after O.I.Meschaninov,, Kharkov 61018, Ukraine; Recruiting
Nadiya Tryschuk, Phone: +380 573431298, Email: nadezhdatr@mail.ru
Nadiya Tryschuk, Principal Investigator
Lviv National Medical University after name Danylo Halytsky based on Communal Clinical City hospital No 5, Department of Propedeutic of Internal Disease, Lviv 79013, Ukraine; Recruiting
Andriy Bazylevych, Phone: 380 322371414, Email: abazylevych@ukr.net
Andriy Bazylevych, Principal Investigator
Chair of Gastroenterology and therapy of Dnipropetrovsk State Medical Academy based on Institute of gastroenterology, Dnepropetrovsk 49074, Ukraine; Recruiting
Yuriy Stepanov, Phone: +380562 271039, Email: stepanov@dsma.dp.ua
Yuriy Stepanov, Principal Investigator
St Marks Hospital, Harrow HA1 3UJ, United Kingdom; Recruiting
Naila Arebi, Phone: 020 8235 4285
Naila Arebi, Principal Investigator
St Marks Hospital, Harrow HA1 3UJ, United Kingdom; Recruiting
Naila Arebi, Phone: 020 8235 4285, Email: naila.arebi@imperial.ac.uk
Naila Arebi, Principal Investigator
University Hospital of Coventry and Warwickshire, Coventry CV2 2DX, United Kingdom; Recruiting
Chuks Nwokolo, Phone: 02476966087, Email: chuka.nwokolo@uhcw.nhs.uk
Chuks Nwokolo, Principal Investigator
Gastrointestinal Unit, Edinburgh EH4 2XU, United Kingdom; Recruiting
Jack Satsangi, Phone: 01315371769, Email: j.satsangi@ed.ac.uk
Jack Satsangi, Principal Investigator
Centrum Leczenia Chorób Cywilizacyjnych, Warszawa, Mazowieckie, Poland; Recruiting
Łukasz Jalocha, Email: clcc@clcc.pl; awieczorek@clcc.pl
Łukasz Jalocha, Principal Investigator
Niepubliczny Zaklad Opieki Zdrowotnej VIVAMED, Warszawa, Mazowieckie 03-580, Poland; Recruiting
Robert Petryka, Email: robert@petrykamed.com
Robert Petryka, Principal Investigator
Centre for Digestive Diseases, Sydney, New South Wales 2046, Australia; Recruiting
Thomas Borody, Phone: +61 2 9713 4011, Email: tborody@cdd.com.au
Thomas Borodoy, Principal Investigator
John Radcliffe Hospital, Headington, Oxford OX3 9DU, United Kingdom; Active, not recruiting
Gastromed S.C., Białystok, Podlaskie 15-842, Poland; Recruiting
Jacek Romanowski, Email: jromatowski@wp.plgastromed@gastromed.info
Jacek Romanowski, Principal Investigator
