NCT01086553

9 mg Budesonide Once Daily (OD) Versus 3 mg Budesonide Three Times Daily (TID) in Active Crohn's Disease

Double-blind, Double-dummy, Randomised, Comparative, Multi-centre Phase III Study on the Efficacy and Tolerability of an 8-week Oral Treatment With 9 mg Budesonide Once Daily vs. 3 mg Budesonide Three-times Daily in Patients With Active Crohn's Disease

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 471 (actual)
• Sponsor: Dr. Falk Pharma GmbH · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study aims to evaluate the efficacy of 9 mg budesonide once daily (OD) versus 3 mg budesonide three-times daily (TID) for the induction of remission in Crohn's disease.

Conditions

• Crohn´s Disease

Interventions

Type	Name	Description
DRUG	budesonide	9mg budesonide OD
DRUG	budesonide	3mg budesonide TID

Timeline

• Start date: 2009-11-01
• Primary completion: 2012-05-01
• Completion: 2012-12-01
• First posted: 2010-03-15
• Last updated: 2014-10-30

Locations

1 site across 1 country: Germany