This study consists of a 2-week placebo-controlled double-blind inter-group efficacy study in moderate to severe refractory ulcerative colitis (UC) patients followed by a maximum of 12-week open-label efficacy and safety study in responders.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
62
oral
oral
Unnamed facility
Chubu Region, Japan
Unnamed facility
Hokkaido Region, Japan
Unnamed facility
Kansai Region, Japan
Unnamed facility
Kanto Region, Japan
Unnamed facility
Kyushu Region, Japan
Improvement of Disease activity index score (DAI score)
Time frame: 2 Weeks
Changes of DAI score ( Total & each item)
Time frame: 2 Weeks
Changes of clinical severity and symptom
Time frame: 2 Weeks
Endoscopic finding
Time frame: 2 Weeks
Patients impression
Time frame: 2 Weeks
Amount of steroid
Time frame: 2 Weeks
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Unnamed facility
Shin'etsu Region, Japan