NCT02280616

Budesonide Effervescent Tablets vs. Viscous Budesonide Suspension vs. Placebo in Eosinophilic Esophagitis

Double-blind, Double-dummy, Randomized, Placebo-controlled, Phase IIa Study on the Efficacy and Tolerability of a 14-day Treatment With Budesonide Effervescent Tablets vs. Viscous Budesonide Suspension vs. Placebo in Patients With Eosinophilic Esophagitis

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 76 (actual)
• Sponsor: Dr. Falk Pharma GmbH · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to assess the efficacy of a low and high dose of a budesonide effervescent tablet and oral viscous budesonide suspension vs. placebo for the induction treatment of active eosinophilic esophagitis.

Conditions

• Eosinophilic Esophagitis

Interventions

Type	Name	Description
DRUG	low dose budesonide tablet	1mg budesonide tablet twice daily AND 5ml placebo suspension twice daily
DRUG	high dose budesonide tablet	2mg budesonide tablet twice daily AND 5ml placebo suspension twice daily
DRUG	high dose budesonide suspension	placebo tablet twice daily AND 5ml \[0.4mg budesonide/ml\] suspension twice daily
DRUG	Placebo	placebo tablet twice daily AND 5ml placebo suspension twice daily

Timeline

• Start date: 2011-06-01
• Primary completion: 2013-04-01
• Completion: 2014-05-01
• First posted: 2014-10-31
• Last updated: 2016-01-21

Locations

1 site across 1 country: Germany