drugset / Trial / NCT01745770

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

NCT01745770

Phase 3 Completed 306 enrolled Dr. Falk Pharma GmbH
RandomizedParallel-groupQuadruple-blindTreatment

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

Timeline

Start
2013-01
Primary completion
2015-03
Completion
2015-06

Drugs

EvaluationDrugModalityDoseRoute
Subject Mesalamine Small molecule 500 mg Oral
Subject Mesalamine Small molecule 1000 mg Oral

Indications