drugset / Trial / NCT00300118

Oral Budesonide vs. Oral Mesalazine in Active Crohn's Disease (CD)

NCT00300118 ↗

Phase 3 Completed 311 enrolled Dr. Falk Pharma GmbH
RandomizedParallel-groupQuadruple-blindTreatment

Summary

The purpose of this study is to determine whether mesalazine or budesonide is more active in the treatment of active Crohn's disease.

Timeline

Start
2004-09
Primary completion
2008-05
Completion
2008-05

Outcome

Met primary endpoint

paper Budesonide 9 mg is at least as effective as mesalamine 4.5 g in patients with mildly to moderately active Crohn's disease. PMID 21070781 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Budesonide Small molecule 9 mg Oral
Comparator Mesalamine Small molecule 4.5 g Oral

Indications