An Open-Label Trial of Losartan Potassium in Participants With Eosinophilic Esophagitis (EoE)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03029091|
Recruitment Status : Active, not recruiting
First Posted : January 24, 2017
Last Update Posted : May 6, 2019
|Condition or disease||Intervention/treatment||Phase|
|Eosinophilic Esophagitis||Drug: Losartan Potassium||Phase 2|
The purpose of this research study is to test the safety of Losartan potassium to see what effects (good and bad) it has on participants and their Eosinophilic Esophagitis (EoE). If a subject has Connective Tissue Disease (CTD) the researchers want to see what effects (good or bad) Losartan has on EoE.
EoE is an inflammatory disease in the esophagus (the tube leading from the mouth to the stomach) that is typically triggered by exposure to certain things in food. Connective Tissue Disorders (CTDs) are disorders that affect the connective tissues in the body, such as fat, bone, and cartilage.
Eosinophils release a protein called TGF-beta. Losartan may decrease the amount of the protein and therefore help EoE and CTD.
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. This medication has not been studied in people with EoE.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||15 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||This study is an open-label study, which means that all participants receive the study medicine.|
|Masking:||None (Open Label)|
|Official Title:||A Preliminary Open-Label Trial of Losartan Potassium in Participants With Eosinophilic Esophagitis (EoE) With or Without a Connective Tissue Disorder|
|Actual Study Start Date :||January 19, 2017|
|Actual Primary Completion Date :||April 2, 2019|
|Estimated Study Completion Date :||August 2019|
Experimental: Losartan treatment
Treatment with Losartan potassium
Drug: Losartan Potassium
Participants will receive Losartan potassium for 4 months.
Other Name: Losartan
- Change in Peak Esophageal Eosinophil Count [ Time Frame: 4 months ]Change from baseline in peak esophageal eosinophil count at the end of treatment visit (or early withdrawal)
- Change in TGF-beta levels [ Time Frame: 4 months ]Change from baseline in blood and esophageal TGF-beta levels at end of treatment (or early withdrawal)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03029091
|United States, California|
|University of California, San Diego|
|La Jolla, California, United States, 92093|
|United States, Illinois|
|Chicago, Illinois, United States, 60208|
|United States, Ohio|
|Cincinnati Children's Hospital Medical Center|
|Cincinnati, Ohio, United States, 45229|
|Principal Investigator:||Marc E Rothenberg, MD, PhD||Children's Hospital Medical Center, Cincinnati|