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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

330 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-31

Study Completion Date

2013-01-31

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.

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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'.

Conditions

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Diverticulitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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A

Group Type EXPERIMENTAL

Mesalazine

Intervention Type DRUG

1.5 g per day

B

Group Type EXPERIMENTAL

Mesalazine

Intervention Type DRUG

3 g per day

C

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

0 g per day

Interventions

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Mesalazine

3 g per day

Intervention Type DRUG

Mesalazine

1.5 g per day

Intervention Type DRUG

Placebo

0 g per day

Intervention Type DRUG

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

Minimum Eligible Age

30 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No