Use of Topical Budesonide in the Treatment of Eosinophilic Esophagitis

• Status: Completed
• Trial end date: 2009-09-01
• Target enrollment: 0
• Participant gender: All

Summary

This study is designed to evaluate whether or not oral viscous budesonide is effective in treating children with Eosinophilic Esophagitis.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ranjan Dohil; University of California, San Diego
• Collaborator: Meritage Pharma, Inc.
• Treatments: Budesonide; Dexlansoprazole; Lansoprazole

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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