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

NCT02280616 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 76

Last updated 2016-01-21

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Dr. Falk Pharma GmbH

    lead INDUSTRY

Principal Investigators

  • Ralph Mueller, PhD · Dr. Falk Pharma GmbH

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-06-30
Primary Completion
2013-04-30
Completion
2014-05-31

Countries

  • Germany

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02280616 on ClinicalTrials.gov