Use of Topical Budesonide in the Treatment of Eosinophilic Esophagitis

Completed · Phase 2 · Has a placebo group

Conditions studied: Eosinophilic Esophagitis

In brief

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

Key facts

Study ID

NCT00638456

Run by

Ranjan Dohil

People needed

32

Starts

2008-02-01

Expected to finish

2009-09-01

Last updated by the study team

2019-08-14

Who can join

Age: 1 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Rady Children's Hospital, San Diego — San Diego, California, United States

Full record on ClinicalTrials.gov

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