Status:
COMPLETED
Budesonide for Eosinophilic Esophagitis
Lead Sponsor:
Swiss EE Study Group
Conditions:
Eosinophilic Esophagitis
Eligibility:
All Genders
14-70 years
Phase:
PHASE2
Brief Summary
Eosinophilic Esophagitis (EE) is a chronic, T-helper 2 cell (TH2) - type inflammatory disorder of the esophagus with a rapidly increasing prevalence. Studies analyzing the natural course of EE provide...
Detailed Description
A randomized, double-blind, placebo-controlled, single center clinical trial to evaluate the efficacy and safety of topically applied Budesonide in the treatment of adult patients with Eosinophilic Es...
Eligibility Criteria
Inclusion
- Isolated Eosinophilic Esophagitis
- Adult patients (age \> 14 years)
- Active disease (clinically and histologically)
- Informed Consent
Exclusion
- Current use of specific treatments for EE
- Secondary causes of esophageal eosinophilia
- Intolerance to Budesonide
- Concomitant therapies for any reason that may affect assessment
- Use of an investigational drug with 30 days of entering the study
- Recent history or suspicion of current drug abuse and alcohol abuse
- Positive serum pregnancy test at the screening visit
- Any unstable serious co-existing medical condition
Key Trial Info
Start Date :
December 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2008
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT00271349
Start Date
December 1 2005
End Date
December 1 2008
Last Update
May 22 2015
Active Locations (1)
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1
Department of Gastroenterology, Kantonsspital
Olten, Canton of Solothurn, Switzerland, 4600