drugset / Trial / NCT01120340

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

NCT01120340

Phase 3 Completed 105 enrolled SOFAR S.p.A.
RandomizedParallel-groupDouble-blindPrevention

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.

Timeline

Start
2005-10
Primary completion
2011-11
Completion
2011-11

Drugs

EvaluationDrugModalityDoseRoute
Comparator Mesalamine Small molecule 1.6 g

Indications