Phase 2 N=32 Randomized Quadruple-blind Treatment

Use of Topical Budesonide in the Treatment of Eosinophilic Esophagitis

Eosinophilic Esophagitis

Bottom Line

View on ClinicalTrials.gov: NCT00638456 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Aug 2019

Primary outcome: Primary: Number of Participants With Improvement of Espohageal Eosinophilia — 13; 0 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Budesonide plus Prevacid (Drug); placebo plus Prevacid (Drug)
Age: Pediatric, Adult, Older Adult · 1+ yrs
Sex: All
Sponsor: Ranjan Dohil
Primary completion: Sep 2009

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants With Improvement of Espohageal Eosinophilia	13; 0	—
SECONDARY Upper Gastrointestinal Endoscopy Score	4.6; 7.8; 1.5; 5.4	—
SECONDARY Symptom Score	3.5; 2.7; 1.2; 1.8	—

Summary

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

Eligibility 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00638456). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.