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 \[NCT00679432\]).
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
61
One Budesonide-MMX 9 mg tablet will be taken in the morning after breakfast for 8 weeks.
Santarus Clinical Investigational Site 9001
Andhra Pradesh, India
Santarus Clinical Investigational Site 9009
Andhra Pradesh, India
Santarus Clinical Investigational Site 9012
Andhra Pradesh, India
The Percentage of Patients Achieving Clinical Remission
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 UCDAI has 4 components. Each component is scored on scale of 0 to 3 (total maximum \[worst\] score = 12). Definitions of component scores are as follows: stool frequency: 0 = normal frequency, 1 = 1 - 2 stools per day greater than normal frequency, 2 = 3 - 4 stools per day greater than normal frequency, and 3 = \> 4 stools per day greater than normal frequency; rectal bleeding: 0 = none, 1 = streaks of blood, 2 = obvious blood, 3 = mostly blood; physician's rating of disease activity: 0 = normal, 1 = mild, 2 = moderate, 3 = severe; mucosal appearance: 0 = normal, 1 = mild friability, 2 = moderate friability, 3 = exudation, spontaneous bleeding.
Time frame: At the end of the 8 week treatment period
The Secondary Efficacy Endpoint is Clinical Improvement
The secondary efficacy endpoint is clinical improvement, defined as a drop in the Ulcerative Colitis Disease Activity Index score of \> or = 3 points from baseline.
Time frame: After 8 weeks treatment period
Safety Evaluations: the Numbers of Patients Who Experience Serious Adverse Events (SAEs) or Other Nonserious Adverse Events (AEs) During the Course of the Study.
Safety will be assessed by evaluating SAEs and AEs. The outcome measure data are the numbers of patients who experienced SAEs or other nonserious AEs.
Time frame: Throughout the 8 week treatment period
Endoscopic Improvement
Greater or equal to a 1 point improvement in the mucosal appearance subscore of the ulcerative colitis disease activity index (UCDAI), from baseline to week 8. The UCDAI mucosal appearance subscore is graded as follows: 0 = normal, 1 = mild friability, 2 = moderate friability, 3 = exudation, spontaneous bleeding.
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Santarus Clinical Investigational Site 9016
Andhra Pradesh, India
Santarus Clinical Investigational Site 9006
Assam, India
Santarus Clinical Investigational Site 9007
Gujarat, India
Santarus Clinical Investigational Site 9004
Karnataka, India
Santarus Clinical Investigational Site 9015
Karnataka, India
Santarus Clinical Investigational Site 9003
Kerala, India
Santarus Clinical Investigational Site 9002
Maharashtra, India
...and 5 more locations
Time frame: 8 weeks