Use of Topical Budesonide in the Treatment of Eosinophilic Esophagitis, a Randomized Clinical Trial

Ranjan Dohil1 site in 1 country32 target enrollmentFebruary 2008

Overview

Phase: Phase 2
Intervention: Budesonide plus Prevacid
Conditions: Eosinophilic Esophagitis
Sponsor: Ranjan Dohil
Enrollment: 32
Locations: 1
Primary Endpoint: Number of Participants With Improvement of Espohageal Eosinophilia
Status: Completed
Last Updated: 6 years ago

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

Registry

clinicaltrials.gov

Start Date

February 2008

End Date

September 2009

Last Updated

6 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Sponsor

Responsible Party

Sponsor Investigator

Principal Investigator

Ranjan Dohil

Professor

University of California, San Diego

•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

•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