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(CB-01-02/02) Randomized Placebo Controlled Trial of Budesonide-multi-matrix System (MMX™) 6 mg and 9 mg in Patients With Ulcerative Colitis

Primary Purpose

Ulcerative Colitis

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Blood sampling, endoscopy
Budesonide MMX® 6 mg
Budesonide MMX® 9 mg
Entocort EC® 3 mg
Placebo
Sponsored by
Bausch Health Americas, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ulcerative Colitis focused on measuring Ulcerative colitis

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 cytochrome P450 3A4 (CYP3A4) inducers or CYP3A4 inhibitors.
    • 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 alanine aminotransferase (ALT), aspartate aminotransferase (AST), gamma-glutamyl transpeptidase (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).

Sites / Locations

  • Centre for Digestive Diseases
  • Royal Adelaide Hospital
  • Box Hill Hospital, Department of Gastroenterology Clive Ward Centre,
  • The Alfred Hospital
  • Monash Medical Centre
  • Imelda Hospital
  • East Viru Central Hospital
  • East Tallinn Central Hospital
  • West Tallinn Central Hospital
  • Tartu University Hospital
  • Hôpital Beaujon
  • Hospital Saint-Louis
  • Yaron Niv
  • CRO - IRCCS - Struttura Operativa Complessa di Gastroenterologia Oncologica
  • Dipartimento di Medicina Interna e Specialità Mediche (DIMI)
  • Divisione di Gastroenterologia - Istituto Clinico Humanitas IRCCS in Gastroenterologia
  • Daugavpils Regional Hospital
  • Paula Stradina Clinical University Hospital
  • Digestive Disease Centre Gastro
  • Clinical University Hospital Gailezers
  • Kaunas Medical University Hospital
  • Siauliai District Hospital
  • M.Marcinkeviciaus Hospital
  • Vilnius University Hospital Santariskiu Klinikos
  • Niepubliczny Zaklad Opieki Zdrowotnej VIVAMED
  • Centrum Leczenia Chorób Cywilizacyjnych
  • Gastromed S.C.
  • Gastromed S.C.Maciej Kralisz, Andrzej Penpicki, Jacek Romatowski, Gabinet, Gastrologiczny i Pracownia Endoskopowa
  • NZOZ Centrum Leczenia Chorob Cywilizacyjnych, oddzial Gdynia, filia Fikakw
  • NZOZ Centrum Leczenia Chorob Cywilizacyjnych
  • Samodzielny Publiczny Zaklad Opieki Zdrowotnej, Szpital Uniwersytecki w Krakowie, Oddzial Kliniczny Kliniki Gastroenterologii, Hepatologii i Chorob Zakaznych,
  • Szpital Uniwersytecki w Krakowie,Oddział Kliniczny Kliniki Gastroenterologii Hematologii i Chorób Zakaźnych
  • Niepubliczny Zaklad Opieki Zdrowotnej POLIMEDICA
  • Endoskopia Sp. z o.o.
  • Endoskopia Sp.z o.o.
  • Indywidualna Specjalistyczna Praktyka Lekarska
  • NZOZ Polimedica
  • Spitalul Clinic Colentina Sectia Gastroenterologie
  • Cabinet Medical
  • Spitalul Judetean Sibiu
  • Centrul de Gastroenterologie Dr. Goldis Adrian
  • Federal State Institution ?National Medical Surgical Center
  • 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"
  • State Scientific Centre of Coloproctology of the Federal Agency for High-Technology Medical Care
  • GUZ of Moscow "City Clinical Hospital #24"
  • Rostov State Medical University
  • Saint-Petersburg GUZ City polyclinic #38 28
  • St. Petersburg State Medical Academy n.a. I.I. Mechnikov
  • Krestovsky Ireland Medical Institute
  • FGU North-West DIstrict Medical Center of Roszdrav
  • ZAO Clinic Dvizhenie
  • Yaroslavl Region Clinical Hospital
  • FNsP Bratislava, Nemocnica Stare Mesto 1st Internal Clinic Mickiewiczova
  • FNsP Bratislava, Nemocnica Ruzinov V. Interna klinika, Gastroenterohepatologicke oddelenie Ruzinovska
  • Gastroenterologické a Hepatologické centrum
  • NsP Nove Mesto nad Vahom n.o.
  • Sahlgrenska Univerity Hospital
  • Lund University Hospital
  • IBD-Unit, Sophiahemmet
  • Div. of Gastroenterology and Hepatology
  • Dept. of Gastroenerology and Hepatology
  • Chair of Gastroenterology and therapy of Dnipropetrovsk State Medical Academy based on Institute of gastroenterology
  • City Clinical Emergency Hospital named after O.I.Meschaninov,
  • Lviv National Medical University after name Danylo Halytsky based on Communal Clinical City hospital No 5, Department of Propedeutic of Internal Disease
  • Odessa city Polyclinic #20, Therapeutic Dept. 6
  • Uzhgorod National University, Hospital surgery chair on the base of Uzhgorod Regional Clinical Hospital
  • Uzhgorod State Medical University, chair of therapy and family medicine, district clinical hospitalof station "Uzhgorod"
  • John Radcliffe Hospital
  • University Hospital of Coventry and Warwickshire
  • Gastrointestinal Unit
  • St Marks Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Active Comparator

Placebo Comparator

Arm Label

1: budesonide-MMX® 6 mg

2: budesonide-MMX® 9 mg

3: Entocort EC® 3 mg

4: Placebo

Arm Description

One budesonide-MMX® 6 mg plus three placebo Entocort EC® overencapsulated capsules daily in the morning after breakfast.

One budesonide-MMX® 9 mg plus three placebo Entocort EC® overencapsulated capsules daily in the morning after breakfast.

Three Entocort EC® 3 mg overencapsulated capsules plus one placebo budesonide MMX® tablet daily in the morning after breakfast.

Three placebo Entocort EC® overencapsulated capsules plus one placebo Budesonide MMX® tablet daily in the morning after breakfast.

Outcomes

Primary Outcome Measures

Clinical and Endoscopic Remission.
Clinical and endoscopic remission defined as an Ulcerative Colitis Disease Activity Index (UCDAI) score ≤ 1, with subscores of 0 for rectal bleeding, stool frequency, and mucosal appearance and with a ≥ 1 point reduction in the endoscopic index score.

Secondary Outcome Measures

Clinical Improvement.
Clinical improvement, defined as a ≥ 3-point improvement in UCDAI from baseline to the end of Week 8.
Endoscopic Improvement.
Greater or equal to a 1 point improvement in the mucosal appearance subscore of the UCDAI, from baseline to week 8. As per the hierarchical testing procedure for secondary endpoints, because clinical improvement was not statistically significant in the ITT population, formal statistical comparisons for endoscopic improvement between the 2 budesonide MMX groups and placebo were not conducted.

Full Information

First Posted
May 14, 2008
Last Updated
November 26, 2019
Sponsor
Bausch Health Americas, Inc.
Collaborators
Cosmo Technologies Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT00679380
Brief Title
(CB-01-02/02) Randomized Placebo Controlled Trial of Budesonide-multi-matrix System (MMX™) 6 mg and 9 mg in Patients With Ulcerative Colitis
Official Title
Efficacy and Safety of Oral Budesonide-MMX™ (CB-01-02) 6 mg and 9 mg Extended Release Tablets in Patients With Mild or Moderate Active Ulcerative Colitis. A Multicentre, Randomised, Double-Blind, Double-Dummy, Comparative Study Versus Placebo With an Additional Reference Arm Evaluating Entocort®EC
Study Type
Interventional

2. Study Status

Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
June 2008 (undefined)
Primary Completion Date
February 2010 (Actual)
Study Completion Date
April 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bausch Health Americas, Inc.
Collaborators
Cosmo Technologies Ltd

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
Detailed Description
Each patient will receive one of the following regimens in the morning after breakfast: One budesonide MMX® 6 mg tablet plus three placebo Entocort enteric-coated (EC®) overencapsulated capsules, or One budesonide MMX® 9 mg tablet plus three placebo Entocort EC® overencapsulated capsules, or Three placebo Entocort EC® overencapsulated capsules plus one placebo budesonide MMX® tablet, or Three Entocort EC® 3 mg overencapsulated capsules plus one placebo budesonide MMX® tablet, daily for eight weeks. Hence, each patient is to take four tablets/capsules per day of active or placebo study medication as per the randomization schedule. Placebo tablets of Budesonide MMX® and placebo overencapsulated capsules of Entocort EC® will be used to maintain the study blind using a double-dummy technique. During the study, five visits to the clinical center are scheduled: one at Screening and three in the double-blind treatment period (Day 1, Day 14, Day 28 and Day 56). A safety follow-up visit will take place about 2 weeks after the final study visit. If a patient is withdrawn from the study before Day 56, they will be asked to attend the study center as soon as possible thereafter so that the Final visit assessments can be conducted.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ulcerative Colitis
Keywords
Ulcerative colitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
514 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1: budesonide-MMX® 6 mg
Arm Type
Experimental
Arm Description
One budesonide-MMX® 6 mg plus three placebo Entocort EC® overencapsulated capsules daily in the morning after breakfast.
Arm Title
2: budesonide-MMX® 9 mg
Arm Type
Experimental
Arm Description
One budesonide-MMX® 9 mg plus three placebo Entocort EC® overencapsulated capsules daily in the morning after breakfast.
Arm Title
3: Entocort EC® 3 mg
Arm Type
Active Comparator
Arm Description
Three Entocort EC® 3 mg overencapsulated capsules plus one placebo budesonide MMX® tablet daily in the morning after breakfast.
Arm Title
4: Placebo
Arm Type
Placebo Comparator
Arm Description
Three placebo Entocort EC® overencapsulated capsules plus one placebo Budesonide MMX® tablet daily in the morning after breakfast.
Intervention Type
Procedure
Intervention Name(s)
Blood sampling, endoscopy
Intervention Description
Blood sampling for hematology and biochemistry and endoscopy with biopsy for histological and endoscopic assessment scores
Intervention Type
Drug
Intervention Name(s)
Budesonide MMX® 6 mg
Intervention Description
6 mg/day, 6 mg tablets
Intervention Type
Drug
Intervention Name(s)
Budesonide MMX® 9 mg
Intervention Description
9 mg/day, 9 mg tablets
Intervention Type
Drug
Intervention Name(s)
Entocort EC® 3 mg
Intervention Description
9 mg/day, 3 mg tablets
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
Clinical and Endoscopic Remission.
Description
Clinical and endoscopic remission defined as an Ulcerative Colitis Disease Activity Index (UCDAI) score ≤ 1, with subscores of 0 for rectal bleeding, stool frequency, and mucosal appearance and with a ≥ 1 point reduction in the endoscopic index score.
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Clinical Improvement.
Description
Clinical improvement, defined as a ≥ 3-point improvement in UCDAI from baseline to the end of Week 8.
Time Frame
8 weeks
Title
Endoscopic Improvement.
Description
Greater or equal to a 1 point improvement in the mucosal appearance subscore of the UCDAI, from baseline to week 8. As per the hierarchical testing procedure for secondary endpoints, because clinical improvement was not statistically significant in the ITT population, formal statistical comparisons for endoscopic improvement between the 2 budesonide MMX groups and placebo were not conducted.
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 cytochrome P450 3A4 (CYP3A4) inducers or CYP3A4 inhibitors. 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 alanine aminotransferase (ALT), aspartate aminotransferase (AST), gamma-glutamyl transpeptidase (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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Simon Travis
Organizational Affiliation
Oxford University Hospitals NHS Trust
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre for Digestive Diseases
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
2046
Country
Australia
Facility Name
Royal Adelaide Hospital
City
Adelaide
ZIP/Postal Code
5000
Country
Australia
Facility Name
Box Hill Hospital, Department of Gastroenterology Clive Ward Centre,
City
Box Hill
ZIP/Postal Code
VIC 3128
Country
Australia
Facility Name
The Alfred Hospital
City
Melbourne
ZIP/Postal Code
3004
Country
Australia
Facility Name
Monash Medical Centre
City
Melbourne
ZIP/Postal Code
3168
Country
Australia
Facility Name
Imelda Hospital
City
Bonheiden
Country
Belgium
Facility Name
East Viru Central Hospital
City
Kohtla-Jarve
ZIP/Postal Code
30322
Country
Estonia
Facility Name
East Tallinn Central Hospital
City
Tallinn
ZIP/Postal Code
10138
Country
Estonia
Facility Name
West Tallinn Central Hospital
City
Tallinn
ZIP/Postal Code
10617
Country
Estonia
Facility Name
Tartu University Hospital
City
Tartu
ZIP/Postal Code
51014
Country
Estonia
Facility Name
Hôpital Beaujon
City
Clichy Cedex
Country
France
Facility Name
Hospital Saint-Louis
City
Paris
Country
France
Facility Name
Yaron Niv
City
Petach Tikva
Country
Israel
Facility Name
CRO - IRCCS - Struttura Operativa Complessa di Gastroenterologia Oncologica
City
Aviano
ZIP/Postal Code
33081
Country
Italy
Facility Name
Dipartimento di Medicina Interna e Specialità Mediche (DIMI)
City
Genova
ZIP/Postal Code
16132
Country
Italy
Facility Name
Divisione di Gastroenterologia - Istituto Clinico Humanitas IRCCS in Gastroenterologia
City
Milan
ZIP/Postal Code
20098
Country
Italy
Facility Name
Daugavpils Regional Hospital
City
Daugavpils
ZIP/Postal Code
5417
Country
Latvia
Facility Name
Paula Stradina Clinical University Hospital
City
Riga
ZIP/Postal Code
1002
Country
Latvia
Facility Name
Digestive Disease Centre Gastro
City
Riga
ZIP/Postal Code
1006
Country
Latvia
Facility Name
Clinical University Hospital Gailezers
City
Riga
ZIP/Postal Code
1038
Country
Latvia
Facility Name
Kaunas Medical University Hospital
City
Kaunas
ZIP/Postal Code
50009
Country
Lithuania
Facility Name
Siauliai District Hospital
City
Siauliai
ZIP/Postal Code
76231
Country
Lithuania
Facility Name
M.Marcinkeviciaus Hospital
City
Vilnius
ZIP/Postal Code
03215
Country
Lithuania
Facility Name
Vilnius University Hospital Santariskiu Klinikos
City
Vilnius
ZIP/Postal Code
08661
Country
Lithuania
Facility Name
Niepubliczny Zaklad Opieki Zdrowotnej VIVAMED
City
Warszawa
State/Province
Mazowieckie
ZIP/Postal Code
03-580
Country
Poland
Facility Name
Centrum Leczenia Chorób Cywilizacyjnych
City
Warszawa
State/Province
Mazowieckie
Country
Poland
Facility Name
Gastromed S.C.
City
Białystok
State/Province
Podlaskie
ZIP/Postal Code
15-842
Country
Poland
Facility Name
Gastromed S.C.Maciej Kralisz, Andrzej Penpicki, Jacek Romatowski, Gabinet, Gastrologiczny i Pracownia Endoskopowa
City
Bialystok
ZIP/Postal Code
15-842
Country
Poland
Facility Name
NZOZ Centrum Leczenia Chorob Cywilizacyjnych, oddzial Gdynia, filia Fikakw
City
Gdynia
ZIP/Postal Code
81-572
Country
Poland
Facility Name
NZOZ Centrum Leczenia Chorob Cywilizacyjnych
City
Gdynia
ZIP/Postal Code
81-572
Country
Poland
Facility Name
Samodzielny Publiczny Zaklad Opieki Zdrowotnej, Szpital Uniwersytecki w Krakowie, Oddzial Kliniczny Kliniki Gastroenterologii, Hepatologii i Chorob Zakaznych,
City
Krakow
ZIP/Postal Code
31-531
Country
Poland
Facility Name
Szpital Uniwersytecki w Krakowie,Oddział Kliniczny Kliniki Gastroenterologii Hematologii i Chorób Zakaźnych
City
Kraków
ZIP/Postal Code
31-531
Country
Poland
Facility Name
Niepubliczny Zaklad Opieki Zdrowotnej POLIMEDICA
City
Lodz
ZIP/Postal Code
90-302
Country
Poland
Facility Name
Endoskopia Sp. z o.o.
City
Sopot
ZIP/Postal Code
81-756
Country
Poland
Facility Name
Endoskopia Sp.z o.o.
City
Sopot
ZIP/Postal Code
81-756
Country
Poland
Facility Name
Indywidualna Specjalistyczna Praktyka Lekarska
City
Wejherowo
ZIP/Postal Code
84-200
Country
Poland
Facility Name
NZOZ Polimedica
City
Łódź
ZIP/Postal Code
90-302
Country
Poland
Facility Name
Spitalul Clinic Colentina Sectia Gastroenterologie
City
Bucuresti
ZIP/Postal Code
020125
Country
Romania
Facility Name
Cabinet Medical
City
Oradea
Country
Romania
Facility Name
Spitalul Judetean Sibiu
City
Sibiu
Country
Romania
Facility Name
Centrul de Gastroenterologie Dr. Goldis Adrian
City
Timisoara
Country
Romania
Facility Name
Federal State Institution ?National Medical Surgical Center
City
Moscow
ZIP/Postal Code
105203
Country
Russian Federation
Facility Name
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"
City
Moscow
ZIP/Postal Code
121309
Country
Russian Federation
Facility Name
State Scientific Centre of Coloproctology of the Federal Agency for High-Technology Medical Care
City
Moscow
ZIP/Postal Code
123423
Country
Russian Federation
Facility Name
GUZ of Moscow "City Clinical Hospital #24"
City
Moscow
ZIP/Postal Code
127006
Country
Russian Federation
Facility Name
Rostov State Medical University
City
Rostov-on-Don
ZIP/Postal Code
344022
Country
Russian Federation
Facility Name
Saint-Petersburg GUZ City polyclinic #38 28
City
St Petersburg
ZIP/Postal Code
193015
Country
Russian Federation
Facility Name
St. Petersburg State Medical Academy n.a. I.I. Mechnikov
City
St Petersburg
Country
Russian Federation
Facility Name
Krestovsky Ireland Medical Institute
City
St-Petersburg
ZIP/Postal Code
197110
Country
Russian Federation
Facility Name
FGU North-West DIstrict Medical Center of Roszdrav
City
St-Petersburg
ZIP/Postal Code
199004
Country
Russian Federation
Facility Name
ZAO Clinic Dvizhenie
City
Volgograd
ZIP/Postal Code
400107
Country
Russian Federation
Facility Name
Yaroslavl Region Clinical Hospital
City
Yaroslavl
Country
Russian Federation
Facility Name
FNsP Bratislava, Nemocnica Stare Mesto 1st Internal Clinic Mickiewiczova
City
Bratislava
ZIP/Postal Code
813 69
Country
Slovakia
Facility Name
FNsP Bratislava, Nemocnica Ruzinov V. Interna klinika, Gastroenterohepatologicke oddelenie Ruzinovska
City
Bratislava
ZIP/Postal Code
826 06
Country
Slovakia
Facility Name
Gastroenterologické a Hepatologické centrum
City
Nitra
ZIP/Postal Code
94901
Country
Slovakia
Facility Name
NsP Nove Mesto nad Vahom n.o.
City
Nové Mesto nad Váhom
Country
Slovakia
Facility Name
Sahlgrenska Univerity Hospital
City
Göteborg
ZIP/Postal Code
416 85
Country
Sweden
Facility Name
Lund University Hospital
City
Lund
ZIP/Postal Code
221 85
Country
Sweden
Facility Name
IBD-Unit, Sophiahemmet
City
Stockholm
ZIP/Postal Code
11486
Country
Sweden
Facility Name
Div. of Gastroenterology and Hepatology
City
Stockholm
ZIP/Postal Code
118 83
Country
Sweden
Facility Name
Dept. of Gastroenerology and Hepatology
City
Stockholm
ZIP/Postal Code
171 76
Country
Sweden
Facility Name
Chair of Gastroenterology and therapy of Dnipropetrovsk State Medical Academy based on Institute of gastroenterology
City
Dnepropetrovsk
ZIP/Postal Code
49074
Country
Ukraine
Facility Name
City Clinical Emergency Hospital named after O.I.Meschaninov,
City
Kharkov
ZIP/Postal Code
61018
Country
Ukraine
Facility Name
Lviv National Medical University after name Danylo Halytsky based on Communal Clinical City hospital No 5, Department of Propedeutic of Internal Disease
City
Lviv
ZIP/Postal Code
79013
Country
Ukraine
Facility Name
Odessa city Polyclinic #20, Therapeutic Dept. 6
City
Odessa
ZIP/Postal Code
65114
Country
Ukraine
Facility Name
Uzhgorod National University, Hospital surgery chair on the base of Uzhgorod Regional Clinical Hospital
City
Uzhorod
Country
Ukraine
Facility Name
Uzhgorod State Medical University, chair of therapy and family medicine, district clinical hospitalof station "Uzhgorod"
City
Uzhorod
Country
Ukraine
Facility Name
John Radcliffe Hospital
City
Headington
State/Province
Oxford
ZIP/Postal Code
OX3 9DU
Country
United Kingdom
Facility Name
University Hospital of Coventry and Warwickshire
City
Coventry
ZIP/Postal Code
CV2 2DX
Country
United Kingdom
Facility Name
Gastrointestinal Unit
City
Edinburgh
ZIP/Postal Code
EH4 2XU
Country
United Kingdom
Facility Name
St Marks Hospital
City
Harrow
ZIP/Postal Code
HA1 3UJ
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
23436336
Citation
Travis SP, Danese S, Kupcinskas L, Alexeeva O, D'Haens G, Gibson PR, Moro L, Jones R, Ballard ED, Masure J, Rossini M, Sandborn WJ. Once-daily budesonide MMX in active, mild-to-moderate ulcerative colitis: results from the randomised CORE II study. Gut. 2014 Mar;63(3):433-41. doi: 10.1136/gutjnl-2012-304258. Epub 2013 Feb 22.
Results Reference
derived

Learn more about this trial

(CB-01-02/02) Randomized Placebo Controlled Trial of Budesonide-multi-matrix System (MMX™) 6 mg and 9 mg in Patients With Ulcerative Colitis

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