Evaluation of Efficacy of Mesalamine in the Long-term Prevention of Diverticulitis Flares

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01120340

Acronym

DIV-01/04

Enrollment

105

Registered

2010-05-10

Start date

2005-10-31

Completion date

2011-11-30

Last updated

2013-09-18

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

Conditions

Diverticular Disease

Brief summary

The purpose of this study is to determine whether mesalamine is effective vs. placebo in the prevention of diverticulitis flares in a 24-months follow-up. The primary end-point of the study is the incidence of diverticulitis flares. Will be made a clinical diagnosis of uncomplicated diverticulitis: fever, leukocytosis, abdominal pain and altered intestinal motility.

Interventions

DRUGmesalamine

mesalamine: 1.6 g/die for ten days/month until 24 months

OTHERplacebo

2 pills/day for ten days/month until 24 months

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* age ≥ 18 years * both males and females patients * positive history of acute diverticulitis flare during the last year. The patients will be recruited only after the complete clinical remission of diverticulitis flare. * patients who have given their free and informed consent

Exclusion criteria

* complicated diverticulitis(fistulas, stenosis, abscesses and/or bleeding) * ascertained hypersensitivity to the salicylates * any severe pathology that can interfere with the treatment or the clinical or instrumental test of the trial * clinically significant renal or hepatic impairment * esophageal, gastric or duodenal ulcer within 30 days prior to randomisation * patients with active malignancy of any type, or history of a malignancy (patients with a history of malignancies that have been surgically removed and who have no evidence of recurrence for at least five years before study enrollment are also acceptable) * treatment with any investigational drug within the previous 30 days * treatment with lactulose or with any compound that lowering the colonic pH can prevent the release of the active moiety from the tablets * recent history or suspicion of alcohol abuse or drug addiction * patients who become unable to conform to protocol * patients with ascertained pregnancy * previous participation in this study

Design outcomes

Primary

Measure	Time frame
diverticulitis relapse	24 months

Countries

Italy

Outcome results

None listed

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