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Use of Topical Budesonide in the Treatment of Eosinophilic Esophagitis

Primary Purpose

Eosinophilic Esophagitis

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Budesonide plus Prevacid
placebo plus Prevacid
Sponsored by
Ranjan Dohil
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Eosinophilic Esophagitis focused on measuring Eosinophils, Esophagitis, Microscopy

Eligibility Criteria

1 Year - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Rady Children's Hospital, San Diego

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

1

2

Arm Description

oral viscous budesonide plus Prevacid

placebo plus Prevacid

Outcomes

Primary Outcome Measures

Number of Participants With Improvement of Espohageal Eosinophilia
Repeat endoscopy was undertaken using the Olympus P160 endoscope (by RD) at 3 months of treatment.

Secondary Outcome Measures

Upper Gastrointestinal Endoscopy Score
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.
Symptom Score
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.

Full Information

First Posted
March 12, 2008
Last Updated
July 25, 2019
Sponsor
Ranjan Dohil
Collaborators
Meritage Pharma, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00638456
Brief Title
Use of Topical Budesonide in the Treatment of Eosinophilic Esophagitis
Official Title
Use of Topical Budesonide in the Treatment of Eosinophilic Esophagitis, a Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
February 2008 (undefined)
Primary Completion Date
September 2009 (Actual)
Study Completion Date
September 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Ranjan Dohil
Collaborators
Meritage Pharma, Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Eosinophilic Esophagitis
Keywords
Eosinophils, Esophagitis, Microscopy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
oral viscous budesonide plus Prevacid
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
placebo plus Prevacid
Intervention Type
Drug
Intervention Name(s)
Budesonide plus Prevacid
Intervention Description
Budesonide is taken daily for three months. In addition, Prevacid is taken twice daily for three months.
Intervention Type
Drug
Intervention Name(s)
placebo plus Prevacid
Intervention Description
Placebo is taken daily for three months. In addition, Prevacid is taken twice daily for three months.
Primary Outcome Measure Information:
Title
Number of Participants With Improvement of Espohageal Eosinophilia
Description
Repeat endoscopy was undertaken using the Olympus P160 endoscope (by RD) at 3 months of treatment.
Time Frame
3 Months
Secondary Outcome Measure Information:
Title
Upper Gastrointestinal Endoscopy Score
Description
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.
Time Frame
Baseline and 3 Months
Title
Symptom Score
Description
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.
Time Frame
Baseline and 3 Months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Year
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ranjan Dohil, MD
Organizational Affiliation
UCSD
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rady Children's Hospital, San Diego
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
20457157
Citation
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. doi: 10.1053/j.gastro.2010.05.001. Epub 2010 May 7.
Results Reference
derived

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Use of Topical Budesonide in the Treatment of Eosinophilic Esophagitis

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