Overview

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

Status:
Completed
Trial end date:
2011-11-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
SOFAR S.p.A.
Treatments:
Mesalamine
Criteria
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