The primary objective of the study was to compare the percentage of subjects in remission after 8 weeks of treatment with SPD476, 2.4 g/day once daily vs placebo and SPD476 4.8 g/day once daily versus placebo
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
343
Imelda General Hospital Dept of Gastroenterology
Bonheiden, Belgium
Percentage of subjects in remission (UC-DAI score <=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 from baseine in UC-DAI score, symptoms, sigmoidscopy score, and PGA
Time frame: 8 weeks
Clinical remission defined as subjects who scored 0 for both the total stool frequency and the total rectal bleeding score
Time frame: 8 weeks
Treatment failure defined as unchanged, worsened missing or imcomplete UC-DAI score
Time frame: 8 weeks
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