The purpose of this study is to investigate the efficacy and safety of budesonide suppository for the treatment of acute ulcerative proctitis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
320
Charité-Campus Benjamin Franklin Universitätsmedizin Berlin
Berlin, Germany
Evang. Krankenhaus Kalk, Medical Department
Cologne, Germany
Resolution of clinical symptoms
Symptoms as reported in the diary
Time frame: 8 weeks
Rate of clinical and endoscopic remission
Symptoms as reported in the diary, ulcerative colitis-disease activity index
Time frame: 8 weeks
Rate of improvement
Symptoms as reported in the diary, ulcerative colitis-disease activity index
Time frame: 8 weeks
Rate of patients with clinical remission
Symptoms as reported in the diary, ulcerative colitis-disease activity index
Time frame: 8 weeks
Rate of patients with endoscopic remission
Ulcerative colitis-disease activity index
Time frame: 8 weeks
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per day