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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
123
Budesonide MMX 6 mg Tablet once daily.
Placebo Tablet once daily.
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
Percentage of Participants Achieving Clinical Remission
Clinical remission was defined as the combined absence of recurrence of rectal bleeding and absence of increased stool frequency.
Time frame: 1, 3, 6, 9, and 12 months
Percentage of Participants With Clinical Relapse
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.
Time frame: 12 months
Percentage of Participants With Endoscopic Relapse
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.
Time frame: 12 months
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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
...and 48 more locations