Two Doses Mesalazine Granules Versus Placebo for the Prevention of Recurrence of Diverticulitis

Study Overview
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Brief Summary
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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.

Detailed Description
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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'.

Official Title
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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

Conditions
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Diverticulitis

Intervention / Treatment
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* Drug: Mesalazine
* Drug: Mesalazine
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: Complicated diverticular disease Right-sided diverticulitis Previous colonic surgery Presence of symptomatic organic disease of the gastrointestinal tract Active colorectal cancer or a history of colorectal cancer Hemorrhagic diathesis Active peptic ulcer disease, local intestinal infection Asthma if careful medical monitoring is not ensured Abnormal hepatic function or liver cirrhosis Abnormal renal function

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br> | Drug: Mesalazine<br>* 1.5 g per day<br>|
| Experimental: B<br> | Drug: Mesalazine<br>* 3 g per day<br>|
| Placebo Comparator: C<br> | Drug: Placebo<br>* 0 g per day<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of recurrence-free patients at 48 weeks and at 96 weeks: |  | 48/96 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to recurrence |  | 48/96 weeks | 
| Occurrence of diverticulitis-associated fever |  | 48/96 weeks | 
| Number of days with left lower quadrant pain |  | 48/96 weeks | 
| Stool consistency |  | 48/96 weeks | 
| Severity of diarrhea |  | 48/96 weeks | 
| Quality of Life (QoL) |  | 48/96 weeks | 
| Health assessment |  | 48/96 weeks | 
| Assessment of efficacy by investigator and patient |  | 48/96 weeks |