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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00679380




Registration number
NCT00679380
Ethics application status
Date submitted
14/05/2008
Date registered
16/05/2008
Date last updated
10/12/2019

Titles & IDs
Public 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
Scientific 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
Secondary ID [1] 0 0
CB-01-02/02
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Ulcerative Colitis 0 0
Condition category
Condition code
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders
Oral and Gastrointestinal 0 0 0 0
Inflammatory bowel disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Surgery - Blood sampling, endoscopy
Treatment: Drugs - Budesonide MMX® 6 mg
Treatment: Drugs - Budesonide MMX® 9 mg
Treatment: Drugs - Entocort EC® 3 mg
Treatment: Drugs - Placebo

Experimental: 1: budesonide-MMX® 6 mg - One budesonide-MMX® 6 mg plus three placebo Entocort EC® overencapsulated capsules daily in the morning after breakfast.

Experimental: 2: budesonide-MMX® 9 mg - One budesonide-MMX® 9 mg plus three placebo Entocort EC® overencapsulated capsules daily in the morning after breakfast.

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

Placebo Comparator: 4: Placebo - Three placebo Entocort EC® overencapsulated capsules plus one placebo Budesonide MMX® tablet daily in the morning after breakfast.


Treatment: Surgery: Blood sampling, endoscopy
Blood sampling for hematology and biochemistry and endoscopy with biopsy for histological and endoscopic assessment scores

Treatment: Drugs: Budesonide MMX® 6 mg
6 mg/day, 6 mg tablets

Treatment: Drugs: Budesonide MMX® 9 mg
9 mg/day, 9 mg tablets

Treatment: Drugs: Entocort EC® 3 mg
9 mg/day, 3 mg tablets

Treatment: Drugs: Placebo
Placebo

Intervention code [1] 0 0
Treatment: Surgery
Intervention code [2] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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.
Timepoint [1] 0 0
8 weeks
Secondary outcome [1] 0 0
Clinical Improvement. - Clinical improvement, defined as a = 3-point improvement in UCDAI from baseline to the end of Week 8.
Timepoint [1] 0 0
8 weeks
Secondary outcome [2] 0 0
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.
Timepoint [2] 0 0
8 weeks

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
75 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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-TNFa) 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).

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Centre for Digestive Diseases - Sydney
Recruitment hospital [2] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [3] 0 0
Box Hill Hospital, Department of Gastroenterology Clive Ward Centre, - Box Hill
Recruitment hospital [4] 0 0
The Alfred Hospital - Melbourne
Recruitment hospital [5] 0 0
Monash Medical Centre - Melbourne
Recruitment postcode(s) [1] 0 0
2046 - Sydney
Recruitment postcode(s) [2] 0 0
5000 - Adelaide
Recruitment postcode(s) [3] 0 0
VIC 3128 - Box Hill
Recruitment postcode(s) [4] 0 0
3004 - Melbourne
Recruitment postcode(s) [5] 0 0
3168 - Melbourne
Recruitment outside Australia
Country [1] 0 0
Belgium
State/province [1] 0 0
Bonheiden
Country [2] 0 0
Estonia
State/province [2] 0 0
Kohtla-Jarve
Country [3] 0 0
Estonia
State/province [3] 0 0
Tallinn
Country [4] 0 0
Estonia
State/province [4] 0 0
Tartu
Country [5] 0 0
France
State/province [5] 0 0
Clichy Cedex
Country [6] 0 0
France
State/province [6] 0 0
Paris
Country [7] 0 0
Israel
State/province [7] 0 0
Petach Tikva
Country [8] 0 0
Italy
State/province [8] 0 0
Aviano
Country [9] 0 0
Italy
State/province [9] 0 0
Genova
Country [10] 0 0
Italy
State/province [10] 0 0
Milan
Country [11] 0 0
Latvia
State/province [11] 0 0
Daugavpils
Country [12] 0 0
Latvia
State/province [12] 0 0
Riga
Country [13] 0 0
Lithuania
State/province [13] 0 0
Kaunas
Country [14] 0 0
Lithuania
State/province [14] 0 0
Siauliai
Country [15] 0 0
Lithuania
State/province [15] 0 0
Vilnius
Country [16] 0 0
Poland
State/province [16] 0 0
Mazowieckie
Country [17] 0 0
Poland
State/province [17] 0 0
Podlaskie
Country [18] 0 0
Poland
State/province [18] 0 0
Bialystok
Country [19] 0 0
Poland
State/province [19] 0 0
Gdynia
Country [20] 0 0
Poland
State/province [20] 0 0
Krakow
Country [21] 0 0
Poland
State/province [21] 0 0
Kraków
Country [22] 0 0
Poland
State/province [22] 0 0
Lodz
Country [23] 0 0
Poland
State/province [23] 0 0
Sopot
Country [24] 0 0
Poland
State/province [24] 0 0
Wejherowo
Country [25] 0 0
Poland
State/province [25] 0 0
Lódz
Country [26] 0 0
Romania
State/province [26] 0 0
Bucuresti
Country [27] 0 0
Romania
State/province [27] 0 0
Oradea
Country [28] 0 0
Romania
State/province [28] 0 0
Sibiu
Country [29] 0 0
Romania
State/province [29] 0 0
Timisoara
Country [30] 0 0
Russian Federation
State/province [30] 0 0
Moscow
Country [31] 0 0
Russian Federation
State/province [31] 0 0
Rostov-on-Don
Country [32] 0 0
Russian Federation
State/province [32] 0 0
St Petersburg
Country [33] 0 0
Russian Federation
State/province [33] 0 0
St-Petersburg
Country [34] 0 0
Russian Federation
State/province [34] 0 0
Volgograd
Country [35] 0 0
Russian Federation
State/province [35] 0 0
Yaroslavl
Country [36] 0 0
Slovakia
State/province [36] 0 0
Bratislava
Country [37] 0 0
Slovakia
State/province [37] 0 0
Nitra
Country [38] 0 0
Slovakia
State/province [38] 0 0
Nové Mesto nad Váhom
Country [39] 0 0
Sweden
State/province [39] 0 0
Göteborg
Country [40] 0 0
Sweden
State/province [40] 0 0
Lund
Country [41] 0 0
Sweden
State/province [41] 0 0
Stockholm
Country [42] 0 0
Ukraine
State/province [42] 0 0
Dnepropetrovsk
Country [43] 0 0
Ukraine
State/province [43] 0 0
Kharkov
Country [44] 0 0
Ukraine
State/province [44] 0 0
Lviv
Country [45] 0 0
Ukraine
State/province [45] 0 0
Odessa
Country [46] 0 0
Ukraine
State/province [46] 0 0
Uzhorod
Country [47] 0 0
United Kingdom
State/province [47] 0 0
Oxford
Country [48] 0 0
United Kingdom
State/province [48] 0 0
Coventry
Country [49] 0 0
United Kingdom
State/province [49] 0 0
Edinburgh
Country [50] 0 0
United Kingdom
State/province [50] 0 0
Harrow

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Bausch Health Americas, Inc.
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
Cosmo Technologies Ltd
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/show/NCT00679380
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Simon Travis
Address 0 0
Oxford University Hospitals NHS Trust
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications