NCT01038739

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

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

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 330 (actual)
• Sponsor: Dr. Falk Pharma GmbH · Industry
• Sex: All
• Age: 30 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Detailed 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'.

Conditions

• Diverticulitis

Interventions

Type	Name	Description
DRUG	Mesalazine	3 g per day
DRUG	Mesalazine	1.5 g per day
DRUG	Placebo	0 g per day

Timeline

• Start date: 2010-01-01
• Primary completion: 2013-01-01
• Completion: 2013-01-01
• First posted: 2009-12-24
• Last updated: 2017-07-21

Locations

1 site across 1 country: United States