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Budesonide for Eosinophilic Esophagitis
Study Summary
This trial is testing whether people with a certain kind of esophageal disease can take breaks from their treatment while still remaining in remission.
- Eosinophilic Esophagitis
Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2016 Phase 4 trial • 222 Patients • NCT02055352Trial Design
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Who is running the clinical trial?
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- You have a condition called eosinophilic esophagitis (EoE) and have not responded well to treatment with topical corticosteroids.You have had or currently have a condition called esophageal strictures, which makes it difficult for food to pass through your throat.
- Group 1: Intervention
- Group 2: Control
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- 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.
- 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
How many participants are being included in this research endeavor?
"Affirmative. Clinicaltrials.gov provides evidence that this clinical trial, which was initially uploaded on November 17th 2021, is actively recruiting participants. Thirty individuals will be accepted from one center for the study duration."
Is this experiment open for enrollment to the public?
"Affirmative. According to the information listed on clinicaltrials.gov, this research endeavour is still searching for candidates; it was first posted in November 2021 and its most recent amendment occurred July 2022. This trial currently seeks 30 volunteers from a single medical site."
Could you please elucidate the safety profile of Budesonide?
"There is a substantial body of evidence indicating the safety of Budesonide, thus it was assigned a rating of 3."
Are any individuals aged 70 or above eligible to partake in this experiment?
"As per the specified standards, only individuals aged 4 to 18 are eligible for enrollment in this medical trial."
What criteria must an individual meet to qualify for involvement in this medical experiment?
"The enrolment criteria for this clinical trial mandates that potential participants must have eosinophilic esophagitis and fall between the ages of 4 to 18. Currently, the researchers are actively recruiting around 30 patients."
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