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Completed

NCT Number: NCT00638456

Use of Topical Budesonide in the Treatment of Eosinophilic Esophagitis

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

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Key information

Conditions

Eosinophilic Esophagitis Digestive System Diseases Eosinophilia Esophageal Diseases Esophagitis Gastroenteritis Gastrointestinal Diseases Hematologic Diseases Hemic and Lymphatic Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Leukocyte Disorders

Age range

1 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Rady Children's Hospital, San Diego

San Diego, California, 92123, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Budesonide plus Prevacid

Drug

Budesonide is taken daily for three months. In addition, Prevacid is taken twice daily for three months.

placebo plus Prevacid

Drug

Placebo is taken daily for three months. In addition, Prevacid is taken twice daily for three months.

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Ranjan Dohil

Other

Collaborators

  • Meritage Pharma, Inc.

Registry information

Official study title

Use of Topical Budesonide in the Treatment of Eosinophilic Esophagitis, a Randomized Clinical Trial

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Mar 19, 2008
Registry last updated
Aug 14, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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