NCT01745770

TID 1000 mg Mesalazine Versus TID 2x500 mg Mesalazine in Active Ulcerative Colitis (UC)

Double-blind, Double-dummy, Randomised, Multi-centre, Comparative Phase III Clinical Study on the Efficacy and Tolerability of an 8 Week Oral Treatment With Three Times Daily 1000 mg Mesalazine Versus Three Times Daily 2x500 mg Mesalazine in Patients With Active Ulcerative Colitis

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 306 (actual)
• Sponsor: Dr. Falk Pharma GmbH · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the trial is to proof whether TID 1000 mg mesalazine is non-inferior to TID 2x 500 mg mesalazine in the treatment of patients with acute ulcerative colitis

Conditions

• Active Ulcerative Colitis

Interventions

Type	Name	Description
DRUG	Mesalazine - TID 1000 mg
DRUG	Mesalazine - TID 2x 500 mg

Timeline

• Start date: 2013-01-01
• Primary completion: 2015-03-01
• Completion: 2015-06-01
• First posted: 2012-12-10
• Last updated: 2016-06-01

Locations

1 site across 1 country: Germany