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Two Doses Mesalazine Granules Versus Placebo for the Prevention of Recurrence of Diverticulitis

Diverticulitis Clinical Trial

Official title:
Double-blind, Dose-response, Randomised, Placebo-controlled, Parallel Group, Multi-centre Phase III Clinical Study on the Efficacy and Tolerability of Mesalazine Granules vs. Placebo for the Prevention of Recurrence of Diverticulitis

Clinical Trial Summary

The purpose of the study is to determine which dose of mesalazine granules compared to placebo is more effective in the prevention of recurrence of disease.

Clinical Trial Description

The primary purpose of the study is to demonstrate the superiority of mesalazine granules compared to placebo in terms of the two primary efficacy variables 'proportion of recurrence-free patients within 48 weeks' and 'proportion of recurrence-free patients within 96 weeks'. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01038739
Study type Interventional
Source Dr. Falk Pharma GmbH
Contact
Status Terminated
Phase Phase 3
Start date January 2010
Completion date January 2013
View Details
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