Mesalazine Granules vs. Placebo for the Prevention of Recurrence of Diverticulitis
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Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Double-blind, Randomized, Placebo-controlled, Parallel Group, Multi-centre Phase III Clinical Study on the Efficacy and Tolerability of Mesalazine Granules vs. Placebo for the Prevention of Recurrence of Diverticulitis
Study Start Date :
Actual Primary Completion Date :
Actual Study Completion Date :
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Ages Eligible for Study:
40 Years to 80 Years (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Diagnosis of left-sided uncomplicated diverticular disease confirmed by ultrasonography or computed tomography
Presence of at least one diverticulum of the left colon
Most recent attack of left-sided uncomplicated diverticulitis responding to antibiotics and/or dietary modification within the last 6 months
C-reactive protein (CRP) > upper limit of normal (ULN) at the start of the most recent attack
Complicated diverticular disease
Previous colonic surgery
Presence of symptomatic organic disease of the gastrointestinal tract
Active colorectal cancer or a history of colorectal cancer
Active peptic ulcer disease, local intestinal infection
Asthma if careful medical monitoring is not ensured