Use of Topical Budesonide in the Treatment of Eosinophilic Esophagitis
Information source: University of California, San Diego
Information obtained from ClinicalTrials.gov on March 21, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Eosinophilic Esophagitis
Intervention: Budesonide (Drug)
Phase: Phase 2
Status: Enrolling by invitation
Sponsored by: University of California, San Diego Official(s) and/or principal investigator(s):
Ranjan Dohil, MD, Principal Investigator, Affiliation: UCSD
Summary
This study is designed to evaluate whether or not oral viscous budesonide is effective in
treating children with Eosinophilic Esophagitis.
Clinical Details
Official title: Use of Topical Budesonide in the Treatment of Eosinophilic Esophagitis, a Randomized Clinical Trial
Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Factorial Assignment, Safety/Efficacy Study
Primary outcome: Histologic resolution of esophageal eosinophilia on repeat endoscopy.
Secondary outcome: Endoscopic resolution of esophagitis and improvement in EE symptom score as assessed by a pediatric EE questionnaire.
Eligibility
Minimum age: 1 Year.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Rady Children's Hospital, San Diego, San Diego, California 92123, United States
Additional Information
Starting date: February 2008
Ending date: April 2010
Last updated: March 18, 2008
|
