The aim of this study was to investigate the safety and efficacy of SPD476 2.4 g/day given twice daily (\[BID\] ie 1.2 g/day BID) and SPD476 4.8g/day given QD compared to placebo in subjects with acute, mild to moderate ulcerative colitis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
280
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Percentage of subjects in remission (Ulcerative Colitis Disease Activity Index score of <= 1, with scores of 0 for rectal bleeding and stool frequency, and a sigmoidoscopy score reduction of 1 point or more from baseline
Time frame: 8 weeks
Clinical improvement as defined by a drop of => 3 points from baseline in the overall UC-DAI score
Time frame: 8 weeks
Change in the UC-DAI score
Time frame: 8 weeks
Change in symptoms (rectal bleeding and stool frequency)
Time frame: 2, 4 and 8 weeks
Change in sigmoidoscopic (mucosal) appearance
Time frame: 8 weeks
Time to withdrawal from the start of study medication
Time frame: Throughout the study period of 8 weeks
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