NCT03029091

An Open-Label Trial of Losartan Potassium in Participants With Eosinophilic Esophagitis (EoE)

A Preliminary Open-Label Trial of Losartan Potassium in Participants With Eosinophilic Esophagitis (EoE) With or Without a Connective Tissue Disorder

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Children's Hospital Medical Center, Cincinnati · Academic / Other
• Sex: All
• Age: 5 Years – 25 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to test the safety and effectiveness of Losartan potassium in subjects with eosinophilic esophagitis (EoE) including those with a connective tissue disorder (CTD) and those without a CTD.

Detailed description

The purpose of this research study is to test the safety and effects (good and bad) of Losartan potassium on participants with eosinophilic esophagitis (EoE). If a participant has a connective tissue disorder (CTD) the researchers want to see what effects (good or bad) Losartan has on EoE. EoE is an inflammatory disease of the esophagus that is typically triggered by exposure to food. Connective tissue disorders (CTDs) are disorders that affect the connective tissues in the body such as tendons and ligaments. A protein called transforming growth factor (TGF)-beta is associated with both EoE and CTD. Losartan may decrease the amount of TGF-beta 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.

Conditions

• Eosinophilic Esophagitis

Interventions

Type	Name	Description
DRUG	Losartan Potassium	Losartan potassium

Timeline

• Start date: 2017-05-23
• Primary completion: 2019-07-22
• Completion: 2019-08-22
• First posted: 2017-01-24
• Last updated: 2020-09-09
• Results posted: 2020-08-10

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study