Mesalazine Granules vs. Placebo for the Prevention of Recurrence of Diverticulitis

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

Status

Terminated

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00695643

Enrollment

345

Registered

2008-06-12

Start date

2008-01-31

Completion date

2012-01-31

Last updated

2017-07-24

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 whether mesalazine granules compared to placebo is effective in prevention of recurrence of disease.

Detailed description

The purpose of the study is to demonstrate the superiority of mesalazine granules compared to placebo in terms of the primary efficacy variable proportion of recurrence-free patients within 48 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

40 Years to 80 Years

Healthy volunteers

Inclusion criteria

* 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

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 within 48 weeks	48 weeks

Secondary

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

Countries

Germany

Outcome results

None listed

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