Use of Topical Budesonide in the Treatment of Eosinophilic Esophagitis - Full Text View

Sponsors and Collaborators:	University of California, San Diego Meritage Pharma, Inc.
Information provided by:	University of California, San Diego
ClinicalTrials.gov Identifier:	NCT00638456

Purpose

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

Condition	Intervention	Phase
Eosinophilic Esophagitis	Drug: Budesonide plus Prevacid Drug: placebo plus Prevacid	Phase II

Drug Information available for: Budesonide Lansoprazole

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Use of Topical Budesonide in the Treatment of Eosinophilic Esophagitis, a Randomized Clinical Trial

Further study details as provided by University of California, San Diego:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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 ]

Estimated Enrollment:	30
Study Start Date:	February 2008
Estimated Study Completion Date:	April 2010
Estimated Primary Completion Date:	February 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator oral viscous budesonide plus Prevacid	Drug: Budesonide plus Prevacid Budesonide is taken daily for three months. In addition, Prevacid is taken twice daily for three months.
2: Placebo Comparator placebo plus Prevacid	Drug: placebo plus Prevacid Placebo is taken daily for three months. In addition, Prevacid is taken twice daily for three months.

Eligibility

Ages Eligible for Study:	1 Year and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00638456

Locations

United States, California
Rady Children's Hospital, San Diego
San Diego, California, United States, 92123

Sponsors and Collaborators

University of California, San Diego

Meritage Pharma, Inc.

Investigators

Principal Investigator:

Ranjan Dohil, MD

UCSD

More Information

Responsible Party:	UCSD ( Ranjan Dohil, MD )
Study ID Numbers:	VPI-106-01
Study First Received:	March 12, 2008
Last Updated:	November 26, 2008
ClinicalTrials.gov Identifier:	NCT00638456
Health Authority:	United States: Food and Drug Administration

Keywords provided by University of California, San Diego:

Eosinophils
Esophagitis
Microscopy

Study placed in the following topic categories:

Esophagitis
Digestive System Diseases
Esophageal disorder
Gastrointestinal Diseases
Budesonide

Lansoprazole
Eosinophilic enteropathy
Esophageal Diseases
Gastroenteritis

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Anti-Infective Agents
Respiratory System Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Gastrointestinal Agents
Anti-Asthmatic Agents
Enzyme Inhibitors

Hormones
Glucocorticoids
Pharmacologic Actions
Autonomic Agents
Therapeutic Uses
Anti-Ulcer Agents
Peripheral Nervous System Agents
Bronchodilator Agents

ClinicalTrials.gov processed this record on January 16, 2009