Use of Topical Budesonide in the Treatment of Eosinophilic Esophagitis

This study has been completed.
Sponsor:
Collaborator:
Meritage Pharma, Inc.
Information provided by:
University of California, San Diego
ClinicalTrials.gov Identifier:
NCT00638456
First received: March 12, 2008
Last updated: September 9, 2009
Last verified: September 2009
  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 2

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:


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):
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 April 17, 2014