Use of Topical Budesonide in the Treatment of Eosinophilic Esophagitis

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-02-29

Study Completion Date

2009-09-30

Brief Summary

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

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Detailed Description

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Conditions

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Eosinophilic Esophagitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

oral viscous budesonide plus Prevacid

Group Type ACTIVE_COMPARATOR

Budesonide plus Prevacid

Intervention Type DRUG

Budesonide is taken daily for three months. In addition, Prevacid is taken twice daily for three months.

2

placebo plus Prevacid

Group Type PLACEBO_COMPARATOR

placebo plus Prevacid

Intervention Type DRUG

Placebo is taken daily for three months. In addition, Prevacid is taken twice daily for three months.

Interventions

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Budesonide plus Prevacid

Budesonide is taken daily for three months. In addition, Prevacid is taken twice daily for three months.

Intervention Type DRUG

placebo plus Prevacid

Placebo is taken daily for three months. In addition, Prevacid is taken twice daily for three months.

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

1 Year

Eligible Sex

ALL

Accepts Healthy Volunteers

No