drugset / Trial / NCT01966783

Budesonide vs. Mesalazine vs. Budesonide/Mesalazine Suppository Combination Therapy in Acute Ulcerative Proctitis

NCT01966783

Phase 2 Completed 320 enrolled Dr. Falk Pharma GmbH
RandomizedParallel-groupQuadruple-blindTreatment

Summary

The purpose of this study is to investigate the efficacy and safety of budesonide suppository for the treatment of acute ulcerative proctitis.

Timeline

Start
2013-09
Primary completion
2015-08
Completion
2015-08

Drugs

EvaluationDrugModalityDoseRoute
Subject Budesonide Small molecule 2 mg Rectal
Subject Budesonide Small molecule 4 mg Rectal
Subject Mesalamine Small molecule 1 g Rectal

Indications