Use of Topical Budesonide in the Treatment of Eosinophilic Esophagitis

Eosinophilic Esophagitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00638456
• Other study ID #: VPI-106-01
• Status: Completed
• Phase: Phase 2
• Start date: February 2008
• Est. completion date: September 2009

Study information

• Verified date: July 2019
• Source: University of California, San Diego
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: September 2009
• Est. primary completion date: September 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year and older

Eligibility

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

Related Conditions & MeSH terms

• Eosinophilic Esophagitis
• Esophagitis

Intervention

Drug:
• Budesonide plus Prevacid
Budesonide is taken daily for three months. In addition, Prevacid is taken twice daily for three months.
• placebo plus Prevacid
Placebo is taken daily for three months. In addition, Prevacid is taken twice daily for three months.

Locations

Country	Name	City	State
United States	Rady Children's Hospital, San Diego	San Diego	California

Sponsors (2)

Lead Sponsor	Collaborator
Ranjan Dohil	Meritage Pharma, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Improvement of Espohageal Eosinophilia	Repeat endoscopy was undertaken using the Olympus P160 endoscope (by RD) at 3 months of treatment.	3 Months
Secondary	Upper Gastrointestinal Endoscopy Score	Endoscopy scoring tool took into account the following categories: Mucosal pallor/reduced vasculature Linear furrows/mucosal thickening White plaques Concentric rings/stricture Friability/"tissue-paper" mucosa Histology scoring tools Epithelial histology score Peak eosinophil count; Each category could score 0-3 for a total maximum score of 15. The higher the score the worse the disease.	Baseline and 3 Months
Secondary	Symptom Score	Total score was based on the following symptoms: Heartburn/regurgitation Abdominal pain Nausea/vomiting Anorexia/early satiety Dysphagia Symptom induced nocturnal wakening Gastrointestinal bleeding; Each symptom could score 0-2 for a maximum score for 14 points. The lower the score the milder the symptoms and the higher the score the more severe symptoms.	Baseline and 3 Months