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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00801723




Registration number
NCT00801723
Ethics application status
Date submitted
2/12/2008
Date registered
3/12/2008
Date last updated
31/08/2020

Titles & IDs
Public title
(CB-01-02/04) Extension Study of Budesonide Multi-Matrix System (MMX) 6 mg in Maintenance Of Remission In Patients With Ulcerative Colitis.
Scientific title
Randomised, Double-Blind, Multi-Centre, 12 Month Extension Study to Evaluate the Safety And Efficacy of Daily Budesonide MMX 6 mg Versus Placebo in the Maintenance of Remission in Subjects With Ulcerative Colitis.
Secondary ID [1] 0 0
CB-01-02/04
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: Drugs - Budesonide MMX 6 mg Tablet
Treatment: Drugs - Placebo Tablet

Experimental: 1: Budesonide MMX® 6 mg - One Budesonide-MMX® 6 mg tablet self-administered by the patients with a glass of water, in the morning after breakfast.

Placebo Comparator: 2: Placebo - One placebo tablet self-administered by the patients with a glass of water, in the morning after breakfast.


Treatment: Drugs: Budesonide MMX 6 mg Tablet
Budesonide MMX 6 mg Tablet once daily.

Treatment: Drugs: Placebo Tablet
Placebo Tablet once daily.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants Achieving Clinical Remission
Timepoint [1] 0 0
1, 3, 6, 9, and 12 months
Secondary outcome [1] 0 0
Percentage of Participants With Clinical Relapse
Timepoint [1] 0 0
12 months
Secondary outcome [2] 0 0
Percentage of Participants With Endoscopic Relapse
Timepoint [2] 0 0
12 months

Eligibility
Key inclusion criteria
- Patients fulfilling the following criteria are eligible for participation in the
study:

- Male and female patients, 18-75 years old, who are able to understand and
voluntarily provide written informed consent.

- Patients in UCDAI remission defined as a UCDAI score = 1 point with a score of 0
for rectal bleeding and stool frequency, and a = 1 point reduction from baseline
in the endoscopy score without any sign of mucosal friability (score 0 for
mucosal appearance).

- Patients who have completed all End of Study assessments for the CB-01-02/01,
CB-01-02/02 and CB-01-02/06 studies.

- Females of child-bearing potential must have had a serum pregnancy test performed
at the End of Study visit of the parent studies and must use an acceptable
contraceptive method throughout the study treatment period.
Minimum age
18 Years
Maximum age
75 Years
Sex
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:

- Subjects who have withdrawn from studies CB-01-02/01, CB 01 02/02 or CB-01-02/06.

- Subjects who did not achieve induction of remission according to the primary
endpoint definition in studies CB-01-02/01, CB 01 02/02 or CB-01-02/06 (i.e.
clinical remission defined as a UCDAI score = 1 point with a score of 0 for
rectal bleeding and stool frequency, and = 1 point reduction from baseline in the
endoscopy score without any sign of mucosal friability [score 0 for mucosal
appearance]).

- Subjects with bone density lower than normal by age and sex (T-score lower than
-1) as assessed via dual energy X-ray absorptiometry (DXA) scans.

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
1/12/2008
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/06/2011
Sample size
Target
Accrual to date
Final
123
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Colorado
Country [5] 0 0
United States of America
State/province [5] 0 0
Florida
Country [6] 0 0
United States of America
State/province [6] 0 0
Georgia
Country [7] 0 0
United States of America
State/province [7] 0 0
Illinois
Country [8] 0 0
United States of America
State/province [8] 0 0
Louisiana
Country [9] 0 0
United States of America
State/province [9] 0 0
Maryland
Country [10] 0 0
United States of America
State/province [10] 0 0
Michigan
Country [11] 0 0
United States of America
State/province [11] 0 0
New Jersey
Country [12] 0 0
United States of America
State/province [12] 0 0
New York
Country [13] 0 0
United States of America
State/province [13] 0 0
North Carolina
Country [14] 0 0
United States of America
State/province [14] 0 0
Ohio
Country [15] 0 0
United States of America
State/province [15] 0 0
Oklahoma
Country [16] 0 0
United States of America
State/province [16] 0 0
Pennsylvania
Country [17] 0 0
United States of America
State/province [17] 0 0
Texas
Country [18] 0 0
United States of America
State/province [18] 0 0
Utah
Country [19] 0 0
United States of America
State/province [19] 0 0
Virginia
Country [20] 0 0
Canada
State/province [20] 0 0
British Columbia
Country [21] 0 0
Canada
State/province [21] 0 0
Ontario
Country [22] 0 0
Canada
State/province [22] 0 0
Quebec

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Bausch Health Americas, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Randomized, double-blind, comparative study versus placebo performed in patients from studies
CB-01-02/01 (NCT00679432), CB-01-02/02 (NCT00679380), or CB-01-02/06 (NCT01100112) who
achieved ulcerative colitis disease activity index (UCDAI) remission after 8 weeks of
treatment.

Patients in remission at the End of Study visit will be given the opportunity to enter the
12-month Maintenance Phase study outlined in this protocol (CB-01-02/04). The End of Study
visit in studies 01, 02, and 06 will be set as the Visit 1 (Day 0) of this study. There will
be no interruption of study treatment between the parent studies and this study.

It is planned that approximately 150 patients will be enrolled in the study. Patients will be
randomly assigned to two groups to receive either budesonide MMX 6 mg or placebo irrespective
of the treatment assigned in studies 01, 02, or 06. Treatments will be administered once a
day after breakfast for a maximum of 12 months or up to the occurrence of the first clinical
relapse, where clinical relapse is defined as combined recurrence of rectal bleeding and
stool frequency = 1-2 stools/day above normal for the patient (score = 1 in both UCDAI
items).

During the study, patients will be assessed for safety and efficacy at Visit 1 and after 1,
3, 6, 9, and 12 months of treatment.

Patients will be contacted by telephone on a monthly basis for safety assessment. In case of
occurrence of symptoms suggestive of clinical relapse, patients will attend an unscheduled
visit at any time during the study.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00801723
Trial related presentations / publications
Public notes
This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed

Contacts
Principal investigator
Name 0 0
Bruce Eric Sands
Address 0 0
Massachusetts General Hospital
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

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00801723