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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/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.
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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.
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Secondary ID [1]
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CB-01-02/04
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Ulcerative Colitis
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Condition category
Condition code
Oral and Gastrointestinal
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Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
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Inflammatory and Immune System
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Other inflammatory or immune system disorders
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Oral and Gastrointestinal
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Inflammatory bowel disease
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Intervention/exposure
Study type
Interventional
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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.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Percentage of Participants Achieving Clinical Remission
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Assessment method [1]
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Clinical remission was defined as the combined absence of recurrence of rectal bleeding and absence of increased stool frequency.
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Timepoint [1]
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1, 3, 6, 9, and 12 months
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Secondary outcome [1]
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Percentage of Participants With Clinical Relapse
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Assessment method [1]
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Clinical relapse was defined as the recurrence of rectal bleeding and/or an abnormal stool frequency \[= 1-2 stools/day above normal for the participant. Clinical remission/relapse status was based on participant diary entries prior to each scheduled visit.
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Timepoint [1]
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12 months
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Secondary outcome [2]
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Percentage of Participants With Endoscopic Relapse
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Assessment method [2]
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Endoscopic relapse was defined as an increase of = 2 points in the Endoscopic Index score from the value calculated at baseline. The score is comprised of four components (granulated scattering reflected light, vascular pattern, vulnerability of mucosa, and mucosal damage). Scores range from 0 to 12, and higher scores indicate more severe (worse) endoscopic findings.
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Timepoint [2]
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12 months
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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.
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Minimum age
18
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Maximum age
75
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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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
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/12/2008
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/06/2011
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Sample size
Target
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Accrual to date
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Final
123
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Recruitment in Australia
Recruitment state(s)
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Recruitment outside Australia
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United States of America
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Alabama
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Arizona
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California
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Colorado
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Florida
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Georgia
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Illinois
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Louisiana
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New York
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North Carolina
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Ohio
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Oklahoma
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Pennsylvania
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Texas
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Utah
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Virginia
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Canada
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British Columbia
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Canada
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Ontario
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Canada
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Quebec
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Bausch Health Americas, Inc.
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Address
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Ethics approval
Ethics application status
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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.
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Trial website
https://clinicaltrials.gov/study/NCT00801723
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Trial related presentations / publications
Gane EJ, Roberts SK, Stedman CA, Angus PW, Ritchie B, Elston R, Ipe D, Morcos PN, Baher L, Najera I, Chu T, Lopatin U, Berrey MM, Bradford W, Laughlin M, Shulman NS, Smith PF. Oral combination therapy with a nucleoside polymerase inhibitor (RG7128) and danoprevir for chronic hepatitis C genotype 1 infection (INFORM-1): a randomised, double-blind, placebo-controlled, dose-escalation trial. Lancet. 2010 Oct 30;376(9751):1467-75. doi: 10.1016/S0140-6736(10)61384-0. Epub 2010 Oct 14.
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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
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Contacts
Principal investigator
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Bruce Eric Sands
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Address
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Massachusetts General Hospital
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT00801723
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