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

Sponsor:	University of California, San Diego
Collaborator:	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

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Use of Topical Budesonide in the Treatment of Eosinophilic Esophagitis, a Randomized Clinical Trial

Resource links provided by NLM:

MedlinePlus related topics: Endoscopy Eosinophilic Disorders

Drug Information available for: Budesonide Lansoprazole

U.S. FDA Resources

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 ]
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 ]

Enrollment:	33
Study Start Date:	February 2008
Study Completion Date:	September 2009
Primary Completion Date:	September 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: 1 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.
Placebo Comparator: 2 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

No publications provided by University of California, San Diego

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Dohil R, Newbury R, Fox L, Bastian J, Aceves S. Oral viscous budesonide is effective in children with eosinophilic esophagitis in a randomized, placebo-controlled trial. Gastroenterology. 2010 Aug;139(2):418-29. Epub 2010 May 7.

Responsible Party:	Ranjan Dohil, MD, UCSD
ClinicalTrials.gov Identifier:	NCT00638456 History of Changes
Other Study ID Numbers:	VPI-106-01
Study First Received:	March 12, 2008
Last Updated:	September 9, 2009
Health Authority:	United States: Food and Drug Administration

Keywords provided by University of California, San Diego:

Eosinophils
Esophagitis
Microscopy

Additional relevant MeSH terms:

Esophagitis
Eosinophilic Esophagitis
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Gastroenteritis
Eosinophilia
Leukocyte Disorders
Hematologic Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Lansoprazole
Budesonide
Anti-Infective Agents

Therapeutic Uses
Pharmacologic Actions
Anti-Ulcer Agents
Gastrointestinal Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists

ClinicalTrials.gov processed this record on February 09, 2012