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Use of Topical Budesonide in the Treatment of Eosinophilic Esophagitis

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ClinicalTrials.gov Identifier: NCT00638456
Recruitment Status : Completed
First Posted : March 19, 2008
Last Update Posted : September 10, 2009
Sponsor:
Collaborator:
Meritage Pharma, Inc.
Information provided by:
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 : 33 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. Histologic resolution of esophageal eosinophilia on repeat endoscopy. [ Time Frame: 3 Months ]

Secondary Outcome Measures :
  1. Endoscopic resolution of esophagitis and improvement in EE symptom score as assessed by a pediatric EE questionnaire. [ Time Frame: 3 Months ]
  2. Open Label Budesonide given and measured through endoscopic resolution of esophagitis and improvement in EE symptoms [ Time Frame: 9 months ]

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
University of California, San Diego
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, MD, UCSD
ClinicalTrials.gov Identifier: NCT00638456     History of Changes
Other Study ID Numbers: VPI-106-01
First Posted: March 19, 2008    Key Record Dates
Last Update Posted: September 10, 2009
Last Verified: September 2009

Keywords provided by 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