The purpose of this study is to investigate the efficacy and safety of 4-week double-blind treatment with PENTASA enema compared with placebo enema in Chinese patients with mild to moderate active left-sided ulcerative colitis, followed by a maximal 28-week open-label extension phase with PENTASA enema and/or PENTASA tablets.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
281
The 6th hospital affiliated to Zhongshan University (there may be other sites in this country)
Guangzhou, China
Clinical remission after 4 weeks treatment
Defined as a total Mayo score ≤2 points, with no subscore \>1 point
Time frame: At week 4
Clinical response after 4 weeks treatment
Defined as a decrease from baseline in total Mayo score ≥3 points and ≥ 30 percent, with an accompanying decrease in the subscore for rectal bleeding ≥ 1 point or an absolute subscore for rectal bleeding of 0 or 1 point
Time frame: At week 4
Change in Quality of Life
Based on the Inflammatory Bowel Disease Questionnaire (IBDQ)
Time frame: From baseline to week 4
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