Two Doses Mesalazine Granules Versus Placebo for the Prevention of Recurrence of Diverticulitis
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ClinicalTrials.gov Identifier: NCT01038739
Recruitment Status :
(Stopped due to futility.)
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.
Condition or disease
Drug: MesalazineDrug: Placebo
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'.
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Double-blind, Dose-response, Randomised, 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:
30 Years to 80 Years (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Diagnosis of left-sided uncomplicated diverticular disease confirmed by 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) or leucocytosis 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