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Proton Pump Inhibitor

Omeprazole for Eosinophilic Esophagitis

Phase 4
Waitlist Available
Led By Nathalie Nguyen, MD
Research Sponsored by University of Colorado, Denver
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Willing to undergo unsedated transnasal endoscopy (TNE)
Weight >20kg
Must not have
Uncontrolled cough, rhinorrhea, rhinitis obstructing nasal passages, GI illness or determination of significant illness at screening
Have a known bleeding disorder
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 8 weeks
Awards & highlights
All Individual Drugs Already Approved
Approved for 10 Other Conditions
No Placebo-Only Group
Pivotal Trial
Drug Has Already Been Approved

Summary

This trial will enroll people with Eosinophilic Esophagitis. They will take Omeprazole for 4 weeks, have an endoscopy, and if the biopsies are abnormal, they will take Omeprazole for 8 more weeks. The trial is to determine how well Omeprazole works for treating Eosinophilic Esophagitis.

Who is the study for?
This trial is for children and young adults aged 8-22 who have been diagnosed with Eosinophilic Esophagitis (EoE) within the last six months. Participants must weigh over 20kg, be able to swallow pills or take medication with apple sauce, and be willing to undergo a transnasal endoscopy without sedation. Those with bleeding disorders, recent steroid treatments, nasal passage issues, GI illnesses, pregnancy plans or allergies to PPIs cannot join.
What is being tested?
The study tests if Omeprazole (a proton pump inhibitor), taken twice daily at a dose of 20mg for four weeks followed by an endoscopic biopsy can improve EoE symptoms in children. If initial biopsies are abnormal after four weeks of treatment, participants continue taking Omeprazole until another check-up at eight weeks.
What are the potential side effects?
Omeprazole may cause side effects such as headaches, stomach pain, nausea or vomiting, diarrhea or constipation. Some people might experience more serious effects like severe allergic reactions but these are less common.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am willing to have a nose scope without sedation.
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I weigh more than 20kg.
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I am between the ages of 8 and 22.
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I can swallow pills or take them with apple sauce.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I do not have an uncontrolled cough, severe cold symptoms, or a significant illness.
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I have a diagnosed bleeding disorder.
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I have used steroid treatment for my esophagus or taken steroids by mouth or injection in the last 8 weeks.
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I haven't taken H2 therapy in the last 16 weeks.
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I am allergic to certain medications used in treatments.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~8 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 8 weeks 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 Histological Response Rate at eight weeks
Change in Histological Response Rate at four weeks
Histological Response at baseline
Secondary study objectives
Eosinophilic Esophagitis Histology Scoring System (HSS) scores at eight weeks
Eosinophilic Esophagitis Histology Scoring System (HSS) scores at enrollment
Eosinophilic Esophagitis Histology Scoring System (HSS) scores at four weeks
+3 more

Awards & Highlights

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.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.

Trial Design

1Treatment groups
Experimental Treatment
Group I: OmeprazoleExperimental Treatment1 Intervention
Participants will receive high dose PPI therapy (Omeprazole 20mg twice daily) and will be evaluated for histological improvement.

Find a Location

Who is running the clinical trial?

University of Colorado, DenverLead Sponsor
1,809 Previous Clinical Trials
2,822,209 Total Patients Enrolled
8 Trials studying Eosinophilic Esophagitis
1,733 Patients Enrolled for Eosinophilic Esophagitis
Children's Hospital ColoradoOTHER
120 Previous Clinical Trials
5,133,101 Total Patients Enrolled
1 Trials studying Eosinophilic Esophagitis
21 Patients Enrolled for Eosinophilic Esophagitis
Nathalie Nguyen, MDPrincipal InvestigatorChildren's Hospital Colorado

Media Library

Omeprazole (Proton Pump Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04149470 — Phase 4
Eosinophilic Esophagitis Research Study Groups: Omeprazole
Eosinophilic Esophagitis Clinical Trial 2023: Omeprazole Highlights & Side Effects. Trial Name: NCT04149470 — Phase 4
Omeprazole (Proton Pump Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04149470 — Phase 4
~17 spots leftby Dec 2025
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