Oral Budesonide-MMX 9mg Extended Release Tablets
This is an open-label, 8 week study, to assess the efficacy and safety of oral Budesonide-MMX 9 mg Extended-release Tablets in patients with mild to moderate, active ulcerative colitis who are not in remission based on the Ulcerative Colitis Disease Activity Index in study CB-01-02/01 (parent study).
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Multicenter, Open-Label Efficacy and Safety Study of Oral Budesonide-MMX 9mg Extended Release Tablets in Patients With Mild to Moderate, Active Ulcerative Colitis|
- The percentage of patients achieving clinical remission [ Time Frame: At the end of the 8 week treatment period ] [ Designated as safety issue: No ]The primary efficacy endpoint is clinical remission at 8 weeks, defined as a Ulcerative Colitis Disease Activity Index score of <or= 1 with a score of 0 for both rectal bleeding and stool frequency, and >or= 1 point reduction from baseline in endoscopy score, without any sign of mucosal friability (a score of 0 for mucosal appearance.
- The secondary efficacy endpoint is clinical improvement [ Time Frame: After 8 weeks treatment peirod ] [ Designated as safety issue: No ]The secondary efficacy enpoint is clinical improvement, defined as a drop in the Ulcerative Colitis Disease Activity Index score of >or= 3 points from baseline, including a reduction in bleeding if the baseline bleeding subscore is >or=2.
- Safety evaluations [ Time Frame: Throughout the 8 week treatment period ] [ Designated as safety issue: Yes ]Safety will be assessed by evaluating adverse events (AEs), laboratory test results, urinalysis, plasma cortisol levels, physical examination findings and vital signs.
|Study Start Date:||February 2010|
|Study Completion Date:||August 2010|
|Primary Completion Date:||July 2010 (Final data collection date for primary outcome measure)|
Drug: Budesonide MMX
Patients who complete the parent study and who do not achieve clinical remission will be eligible to receive 8 weeks of open-label treatment with Budesonide-MMX 9mg if they satisfy the entry criteria for this study.