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

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

Status

Terminated

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01038739

Enrollment

330

Registered

2009-12-24

Start date

2010-01-31

Completion date

2013-01-31

Last updated

2017-07-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diverticulitis

Brief summary

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

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'.

Interventions

DRUGMesalazine

3 g per day

DRUGPlacebo

0 g per day

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

30 Years to 80 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Proportion of recurrence-free patients at 48 weeks and at 96 weeks:	48/96 weeks

Secondary

Measure	Time frame
Occurrence of diverticulitis-associated fever	48/96 weeks
Number of days with left lower quadrant pain	48/96 weeks
Stool consistency	48/96 weeks
Time to recurrence	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
Severity of diarrhea	48/96 weeks

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026