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Use of Topical Budesonide in the Treatment of Eosinophilic Esophagitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00638456
Recruitment Status : Completed
First Posted : March 19, 2008
Results First Posted : August 14, 2019
Last Update Posted : August 14, 2019
Sponsor:
Collaborator:
Meritage Pharma, Inc.
Information provided by (Responsible Party):
Ranjan Dohil, University of California, San Diego

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

Condition or disease Intervention/treatment Phase
Eosinophilic Esophagitis Drug: Budesonide plus Prevacid Drug: placebo plus Prevacid Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Use of Topical Budesonide in the Treatment of Eosinophilic Esophagitis, a Randomized Clinical Trial
Study Start Date : February 2008
Actual Primary Completion Date : September 2009
Actual Study Completion Date : September 2009

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Arms and Interventions
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Arm Intervention/treatment
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.


Outcome Measures
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Primary Outcome Measures :
  1. Number of Participants With Improvement of Espohageal Eosinophilia [ Time Frame: 3 Months ]
    Repeat endoscopy was undertaken using the Olympus P160 endoscope (by RD) at 3 months of treatment.


Secondary Outcome Measures :
  1. Upper Gastrointestinal Endoscopy Score [ Time Frame: Baseline and 3 Months ]

    Endoscopy scoring tool took into account the following categories:

    Mucosal pallor/reduced vasculature Linear furrows/mucosal thickening White plaques Concentric rings/stricture Friability/"tissue-paper" mucosa Histology scoring tools Epithelial histology score Peak eosinophil count

    Each category could score 0-3 for a total maximum score of 15. The higher the score the worse the disease.


  2. Symptom Score [ Time Frame: Baseline and 3 Months ]

    Total score was based on the following symptoms:

    Heartburn/regurgitation Abdominal pain Nausea/vomiting Anorexia/early satiety Dysphagia Symptom induced nocturnal wakening Gastrointestinal bleeding

    Each symptom could score 0-2 for a maximum score for 14 points. The lower the score the milder the symptoms and the higher the score the more severe symptoms.



Eligibility Criteria
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Ages Eligible for Study:   1 Year and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00638456


Locations
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United States, California
Rady Children's Hospital, San Diego
San Diego, California, United States, 92123
Sponsors and Collaborators
Ranjan Dohil
Meritage Pharma, Inc.
Investigators
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Principal Investigator: Ranjan Dohil, MD UCSD
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Ranjan Dohil, Professor, University of California, San Diego
ClinicalTrials.gov Identifier: NCT00638456    
Other Study ID Numbers: VPI-106-01
First Posted: March 19, 2008    Key Record Dates
Results First Posted: August 14, 2019
Last Update Posted: August 14, 2019
Last Verified: July 2019
Keywords provided by Ranjan Dohil, University of California, San Diego:
Eosinophils
Esophagitis
Microscopy
Additional relevant MeSH terms:
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Eosinophilic Esophagitis
Esophagitis
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Gastroenteritis
Eosinophilia
Leukocyte Disorders
Hematologic Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Budesonide
Lansoprazole
Dexlansoprazole
 Anti-Inflammatory Agents
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
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action