The purpose of the study is to determine which dose of mesalazine granules compared to placebo is more effective in the prevention of recurrence of disease.
The primary purpose of the study is to demonstrate the superiority of mesalazine granules compared to placebo in terms of the two primary efficacy variables 'proportion of recurrence-free patients within 48 weeks' and 'proportion of recurrence-free patients within 96 weeks'.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
330
United Medical Research
New Smyrna Beach, Florida, United States
Proportion of recurrence-free patients at 48 weeks and at 96 weeks:
Time frame: 48/96 weeks
Time to recurrence
Time frame: 48/96 weeks
Occurrence of diverticulitis-associated fever
Time frame: 48/96 weeks
Number of days with left lower quadrant pain
Time frame: 48/96 weeks
Stool consistency
Time frame: 48/96 weeks
Severity of diarrhea
Time frame: 48/96 weeks
Quality of Life (QoL)
Time frame: 48/96 weeks
Health assessment
Time frame: 48/96 weeks
Assessment of efficacy by investigator and patient
Time frame: 48/96 weeks
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