Eosinophilic Esophagitis Clinical Trial
Official title:
A Preliminary, Open-label Trial of Losartan Potassium in Participants With Eosinophilic Esophagitis (EoE) With or Without a Connective Tissue Disorder.
The purpose of this research study is to test the safety of losartan potassium and see what effects (good and bad) it has on you and your eosinophilic esophagitis.
Losartan is a drug that is approved by the United States Food and Drug Administration (FDA)
for use in adults and children over 6 years of age who have high blood pressure. Losartan has
been safe when administered to patients with normal blood pressure. This medication has not
been studied in people with eosinophilic esophagitis or connective tissue disorder.
Eosinophils are a type of white blood cell that induces inflammation. Eosinophils with other
inflammatory cells produce a protein called TGF-β, which may contribute to part of EoE.
Losartan may reduce the amount of this protein and therefore, be a treatment for eosinophilic
esophagitis.
You will be in the research study for approximately 4 months. Participation in this research
study will involve 9 study visits. Of the 9 study visits, at least 3 visits will take place
in the clinic; the other visits may take place over the telephone.
Throughout the study, the following activities will occur:
1. A physical and vital signs will be obtained
2. There will be two endoscopies performed one at the beginning and one at the end of the
study
3. Blood will be obtained up to three times
4. Pregnancy tests will be performed
5. Quality-of-life questionnaires will be completed
This is an open-label trial, which means that if you choose to enroll and you meet screening
criteria, you will receive Losartan as a treatment. You will start the study drug at a low
dose. It will be increased at vist 3 the 1 month visit. The dose of study drug will be
increased depending on your weight and how well you tolerate each dose but will not exceed
100mg of study drug per day. It may be increased or decreased during the study if there are
any side effects. If you do not have certain side effects, you will take each dose of the
study drug between 21 and 28 days until your next study visit. You will swallow a pill or
liquid once or twice a day.
This study will consist of 4 phases: screening, treatment (titration and maintenance), end of
treatment, and follow-up. Participants that are between 5 to 18 years of age, as well as the
parent or legal guardian will be asked to complete questionnaires of quality-of-life symptom
severity questionnaires. Participants between the age of 19 and 21 will also have to fill out
these questionnaires, but parents/guardians will not have to fill these out. If you are the
parent or caretaker, the only study activity in which you will be involved is the completion
of questionnaires about you and your family.
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