(CB-01-02/04) Extension Study of Budesonide Multi-Matrix System (MMX) 6 mg in Maintenance Of Remission In Patients With Ulcerative Colitis.
NCT ID: NCT00801723
Last Updated: 2020-08-31
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
123 participants
INTERVENTIONAL
2008-12-31
2011-06-30
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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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.
Budesonide MMX 6 mg Tablet
Budesonide MMX 6 mg Tablet once daily.
2: Placebo
One placebo tablet self-administered by the patients with a glass of water, in the morning after breakfast.
Placebo Tablet
Placebo Tablet once daily.
Interventions
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Budesonide MMX 6 mg Tablet
Budesonide MMX 6 mg Tablet once daily.
Placebo Tablet
Placebo Tablet once daily.
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
18 Years
75 Years
ALL
No
Sponsors
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Bausch Health Americas, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Bruce Eric Sands
Role: PRINCIPAL_INVESTIGATOR
Massachusetts General Hospital
Simon Travis
Role: PRINCIPAL_INVESTIGATOR
Oxford University Hospitals NHS Trust
Locations
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Santarus Clinical Investigational Site 5051
Huntsville, Alabama, United States
Santarus Clinical Investigational Site 5088
Tucson, Arizona, United States
Santarus Clinical Investigational Site 5044
Anaheim, California, United States
Santarus Clinical Investigational Site 5087
Lakewood, California, United States
Santarus Clinical Investigational Site 5033
Los Angeles, California, United States
Santarus Clinical Investigational Site 5070
Palm Springs, California, United States
Santarus Clinical Investigational Site 5067
San Diego, California, United States
Santarus Clinical Investigational Site 5064
Lakewood, Colorado, United States
Santarus Clinical Investigational Site 5089
Boynton Beach, Florida, United States
Santarus Clinical Investigational Site 5041
Hollywood, Florida, United States
Santarus Clinical Investigational Site 5055
New Smyrna Beach, Florida, United States
Santarus Clinical Investigational Site 5074
Port Orange, Florida, United States
Santarus Clinical Investigational Site 5032
Tampa, Florida, United States
Santarus Clinical Investigational Site 5009
Tampa, Florida, United States
Santarus Clinical Investigational Site 5047
Winter Park, Florida, United States
Santarus Clinical Investigational Site 5003
Zephyrhills, Florida, United States
Santarus Clinical Investigational Site 5016
Atlanta, Georgia, United States
Santarus Clinical Investigational Site 5056
Columbus, Georgia, United States
Santarus Clinical Investigational Site 5068
Evanston, Illinois, United States
Santarus Clinical Investigational Site 5008
Metairie, Louisiana, United States
Santarus Clinical Investigational Site 5090
Annapolis, Maryland, United States
Santarus Clinical Investigational Site 5025
Baltimore, Maryland, United States
Santarus Clinical Investigational Site 5092
Hollywood, Maryland, United States
Santarus Clinical Investigational Site 5077
Prince Frederick, Maryland, United States
Santarus Clinical Investigational Site 5010
Chesterfield, Michigan, United States
Santarus Clinical Investigational Site 5006
Troy, Michigan, United States
Santarus Clinical Investigational Site 5004
Wyoming, Michigan, United States
Santarus Clinical Investigational Site 5005
Marlton, New Jersey, United States
Santarus Clinical Investigational Site 5011
Great Neck, New York, United States
Santarus Clinical Investigational Site 5101
New York, New York, United States
Santarus Clinical Investigational Site 5020
Pittsford, New York, United States
Santarus Clinical Investigational Site 5096
Fayetteville, North Carolina, United States
Santarus Clinical Investigational Site 5058
Huntersville, North Carolina, United States
Santarus Clinical Investigational Site 5091
New Bern, North Carolina, United States
Santarus Clinical Investigational Site 5045
Cincinnati, Ohio, United States
Santarus Clinical Investigational Site 5078
Dayton, Ohio, United States
Santarus Clinical Investigational Site 5001
Yukon, Oklahoma, United States
Santarus Clinical Investigational Site 5066
Duncansville, Pennsylvania, United States
Santarus Clinical Investigational Site 5065
Pottstown, Pennsylvania, United States
Santarus Clinical Investigational Site 5035
Sayre, Pennsylvania, United States
Santarus Clinical Investigational Site 5021
Austin, Texas, United States
Santarus Clinical Investigational Site 5076
Houston, Texas, United States
Santarus Clinical Investigational Site 5019
Houston, Texas, United States
Santarus Clinical Investigational Site 5036
Houston, Texas, United States
Santarus Clinical Investigational Site 5063
Irving, Texas, United States
Santarus Clinical Investigational Site 5072
Kingwood, Texas, United States
Santarus Clinical Investigational Site 5054
La Porte, Texas, United States
Santarus Clinical Investigational Site 5030
Lewisville, Texas, United States
Santarus Clinical Investigational Site 5093
Plano, Texas, United States
Santarus Clinical Investigational Site 5100
San Antonio, Texas, United States
Santarus Clinical Investigational Site 5079
San Antonio, Texas, United States
Santarus Clinical Investigational Site 5015
Salt Lake City, Utah, United States
Santarus Clinical Investigational Site 5097
Christiansburg, Virginia, United States
Santarus Clinical Investigational Site 6014
Vancouver, British Columbia, Canada
Santarus Clinical Investigational Site 6008
Victoria, British Columbia, Canada
Santarus Clinical Investigational Site 6004
Richmond Hill, Ontario, Canada
Santarus Clinical Investigational Site 6006
Toronto, Ontario, Canada
Santarus Clinical Investigational Site 6013
Longueuil, Quebec, Canada
Countries
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Other Identifiers
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CB-01-02/04
Identifier Type: -
Identifier Source: org_study_id
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