Status:
COMPLETED
Use of Topical Budesonide in the Treatment of Eosinophilic Esophagitis
Lead Sponsor:
Ranjan Dohil
Collaborating Sponsors:
Meritage Pharma, Inc.
Conditions:
Eosinophilic Esophagitis
Eligibility:
All Genders
1+ years
Phase:
PHASE2
Brief Summary
This study is designed to evaluate whether or not oral viscous budesonide is effective in treating children with Eosinophilic Esophagitis.
Eligibility Criteria
Inclusion
- Histologic evidence of EE defined as greater than 20 eosinophils per hpf on esophageal biopsy
- Ages 1 yrs and older
- Ability to continue the same diet that the patient was on at the time of EGD with biopsy
Exclusion
- Adverse reaction or allergy to budesonide
- Pregnancy
- Chronic diseases requiring immunomodulatory therapy
- Use of swallowed topical corticosteroids for EE within the past 3 months
- Use of systemic steroids 2 months prior to study entry
- Upper gastrointestinal bleed within 4 months of study entry
- Chronic use of medications that predispose to upper gastrointestinal bleeding including non-steroidal anti-inflammatory medications or anticoagulants
- Evidence of adrenal suppression prior to study entry
- Evidence of concurrent eosinophilic gastritis, enteritis, colitis, or proctitis
- Recent changes in asthma or allergic rhinitis therapy for 3 months
Key Trial Info
Start Date :
February 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2009
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT00638456
Start Date
February 1 2008
End Date
September 1 2009
Last Update
August 14 2019
Active Locations (1)
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1
Rady Children's Hospital, San Diego
San Diego, California, United States, 92123