Clinical trial NCT01808196
Conditions: Eosinophilic Esophagitis Connective Tissue Disorders
Keywords: Eosinophilic Esophagitis Connective Tissue Disorders Drug trial
Sponsor: Children's Hospital Medical Center, Cincinnati
Start date: 2013-10-10; Completion date: 2015-02-13
Enrollment: 6 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
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.

Detailed description:
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.

Arms: arm 1: Participants with eosinophilic esophagitis receive Losartan daily
Interventions: intervention 1: Losartan Potassium
Intervention descriptions: intervention 1: The dose of study drug is dependent on body weight and tolerance but did not exceed 100 mg.

Protocol documents: