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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
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 0 and week 8
Awards & highlights
Drug Has Already Been Approved
Pivotal Trial
All Individual Drugs Already Approved
Approved for 10 Other Conditions

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

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 0 and week 8
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 0 and week 8 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in esophageal eosinophilia
Secondary study objectives
Change in Endoscopic Reference Score
Change in Symptom Scoring

Awards & Highlights

Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 10 Other Conditions
This treatment demonstrated efficacy for 10 other conditions.

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

Find a Location

Who is running the clinical trial?

Claire DanielsLead Sponsor
~14 spots leftby Nov 2025
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