The purpose of the study is to determine whether mesalazine granules compared to placebo is effective in prevention of recurrence of disease.
The purpose of the study is to demonstrate the superiority of mesalazine granules compared to placebo in terms of the primary efficacy variable proportion of recurrence-free patients within 48 weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
345
3 g per day
0 g per day
Evang. Krankenhaus Kalk, Medical department
Cologne, Germany
Proportion of recurrence-free patients within 48 weeks
Time frame: 48 weeks
Time to recurrence
Occurrence of diverticulitis-associated fever
Time frame: 48 weeks
Number of days with left lower quadrant pain
Time frame: 48 weeks
Stool consistency
Time frame: 48 weeks
Severity of diarrhea
Time frame: 48 weeks
Quality of Life (QoL)
Time frame: 48 weeks
Health assessment
Time frame: 48 weeks
Assessment of efficacy by investigator and patient
Time frame: 48 weeks
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