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Corticosteroid
Endoscopy while on study drug for Eosinophilic Esophagitis
Phase 4
Waitlist Available
Research Sponsored by Claire Daniels
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
age 6 to 60 years old
DEERS (defense enrollment eligibility reporting system) eligible
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 0 and week 8
Awards & highlights
Study Summary
This trial will compare the effectiveness of a combination of two drugs versus one of the drugs alone in treating Eosinophilic Esophagitis. The success of the treatment will be measured by the number of a certain type of white blood cell in the esophageal tissue.
Eligible Conditions
- Eosinophilic Esophagitis
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ week 0 and week 8
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 0 and week 8
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in esophageal eosinophilia
Secondary outcome measures
Change in Endoscopic Reference Score
Change in Symptom Scoring
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Fluticasone and omeprazoleExperimental Treatment6 Interventions
These patients will be prescribed swallowed fluticasone and omeprazole to be taken together for the 8 week period. Dosing will be based on weight and age. Primary outcome measure will be the change in esophageal biopsy histology, or number of eosinophils per high powered field, from week 0 to week 8. Secondary outcomes will include changes in the following variables between week 0 and 8: eotaxin staining of the esophageal biopsy tissue, endoscopic scoring from photos of the esophagus obtained during endoscopy, and symptom scoring based on surveys.
Group II: Fluticasone and placeboPlacebo Group6 Interventions
These patients will be prescribed swallowed fluticasone and a placebo medication that appears identical to omeprazole to be taken together for an 8 week period. Dosing will be based on weight and age. Primary outcome measure will be the change in esophageal biopsy histology, or number of eosinophils per high powered field, from week 0 to week 8. Secondary outcomes will include changes in the following variables between week 0 and 8: eotaxin staining of the esophageal biopsy tissue, endoscopic scoring from photos of the esophagus obtained during endoscopy, and symptom scoring based on surveys.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Fluticasone
FDA approved
Omeprazole
FDA approved
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Who is running the clinical trial?
Claire DanielsLead Sponsor
Frequently Asked Questions
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