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

NCT01120340 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 105

Last updated 2013-09-18

No results posted yet for this study

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.

Conditions

  • Diverticular Disease

Interventions

DRUG

mesalamine

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

OTHER

placebo

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

Sponsors & Collaborators

  • SOFAR S.p.A.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-10-31
Primary Completion
2011-11-30
Completion
2011-11-30

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01120340 on ClinicalTrials.gov