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Omeprazole for Eosinophilic Esophagitis
Study 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.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
Media Library
- I have a diagnosed bleeding disorder.I expect to change my corticosteroid medication soon.I have used steroid treatment for my esophagus or taken steroids by mouth or injection in the last 8 weeks.I was diagnosed with Eosinophilic Esophagitis in the last 6 months.I do not have an uncontrolled cough, severe cold symptoms, or a significant illness.I am willing to have a nose scope without sedation.I haven't taken H2 therapy in the last 16 weeks.I weigh more than 20kg.I am allergic to certain medications used in treatments.I am between the ages of 8 and 22.I can swallow pills or take them with apple sauce.
- Group 1: Omeprazole
- Approved for 10 Other Conditions - This treatment demonstrated efficacy for 10 other conditions.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- 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.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
What are the overarching objectives of this research endeavor?
"This 8 week trial will measure the Change in Histological Response Rate at four weeks as its primary outcome. Secondary outcomes include PEESS (Pediatric Eosinophilic Esophagitis Symptom Severity Module) scores, which are an assessment tool to gauge a patient's experience with symptoms of EoE over the past month; and two sets of HSS(Histology Scoring System) Scores - one taken prior to treatment and another after eight weeks post-treatment."
What clinical conditions typically respond to a regimen of Omeprazole 20mg BID?
"Omeprazole 20mg BID is an effective solution for treating gastroesophageal reflux disease, heartburn and Zollinger-Ellison Syndrome."
Are new participants currently being admitted to this trial?
"According to the records on clinicaltrials.gov, this trial is currently seeking participants and was first posted in October 7th 2020 before receiving its most recent update July 28th 2022."
How many participants are engaged in this research study?
"Affirmatively, clinicaltrials.gov has documented that this trial is still inviting patients to join the study. It was initially made public on October 7th 2020 and last modified on July 28th 2022 , with 90 participants being sought from one site."
Does my profile qualify me to be a participant in this research?
"To participate in this medical trial, participants must have eosinophilic esophagitis and be between 8 to 22 years old. The study is hoping to recruit a total of 90 patients."
Has the Federal Drug Administration authorized Omeprazole 20mg BID?
"Omeprazole 20mg BID's safety is rated a 3 on our 1-3 scale. This drug has been approved by the FDA due to its advancement into Phase 4 trials."
Have other clinical trials featured the administration of a 20mg dose of Omeprazole twice daily?
"Presently, 10 clinical trials are being held to assess the efficacy of Omeprazole 20mg BID. None of these studies have advanced beyond Phase 3. Most sites for this research are located in Portland, Oregon; however there exist 50 other institutions that conduct similar experiments with this medication."
Does this clinical investigation admit participants aged above sixty?
"The age range for enrolment into this medical trial is 8 to 22 years old. There are 28 trials available for individuals under the legal age and 44 clinical studies accessible to those over retirement age."
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