Use of Topical Budesonide in the Treatment of Eosinophilic Esophagitis - Tabular View

Tracking Information

First Received Date ^ICMJE

March 12, 2008

Last Updated Date

September 9, 2009

Start Date ^ICMJE

February 2008

Primary Completion Date

September 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Histologic resolution of esophageal eosinophilia on repeat endoscopy. [ Time Frame: 3 Months ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00638456 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Endoscopic resolution of esophagitis and improvement in EE symptom score as assessed by a pediatric EE questionnaire. [ Time Frame: 3 Months ] [ Designated as safety issue: No ]
Open Label Budesonide given and measured through endoscopic resolution of esophagitis and improvement in EE symptoms [ Time Frame: 9 months ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Endoscopic resolution of esophagitis and improvement in EE symptom score as assessed by a pediatric EE questionnaire. [ Time Frame: 3 Months ] [ Designated as safety issue: No ]

Descriptive Information

Brief Title ^ICMJE

Use of Topical Budesonide in the Treatment of Eosinophilic Esophagitis

Official Title ^ICMJE

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

Brief Summary

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

Detailed Description

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Eosinophilic Esophagitis

Intervention ^ICMJE

Drug: Budesonide plus Prevacid
Drug: placebo plus Prevacid

Study Arms / Comparison Groups

Active Comparator: oral viscous budesonide plus Prevacid
Placebo Comparator: placebo plus Prevacid

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

September 2009

Primary Completion Date

September 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

1 Year and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00638456

Responsible Party

Ranjan Dohil, MD, UCSD

Study ID Numbers ^ICMJE

VPI-106-01

Study Sponsor ^ICMJE

University of California, San Diego

Collaborators ^ICMJE

Meritage Pharma, Inc.

Investigators ^ICMJE

Principal Investigator:

Ranjan Dohil, MD

UCSD

Information Provided By

University of California, San Diego

Verification Date

September 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP