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Completed

NCT Number: NCT01120340

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Ospedale di Seriate, Seriate, Bergamo, Italy

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mesalamine

Drug

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

Placebo

Other

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

Primary outcomes

  1. diverticulitis relapse

    Time frame: 24 months

Sponsors and collaborators

Lead sponsor

SOFAR S.p.A.

Industry

Registry information

Acronym: DIV-01/04

Important dates

Study start
2005
Primary completion
2011
Study completion
2011
First posted
May 10, 2010
Registry last updated
Sep 18, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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