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An Open-Label Trial of Losartan Potassium in Participants With Eosinophilic Esophagitis (EoE)
The purpose of this study is to test the safety and effectiveness of Losartan potassium in subjects with Eosinophilic Esophagitis (EoE), both those with a connective tissue disorder (CTD) and those without a CTD.
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.
An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.
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|Eligible Ages||5 Years - 25 Years|
- - Written informed consent/assent - confirmed, active EoE (at Screening or within 12 weeks prior to enrollment) - does or does not have diagnosis of a connective tissue disorder (CTD) - has been on a high dose of proton pump inhibitor (PPI) for at least 8 weeks prior to a diagnostic endoscopy of EoE without histologic resolution (i.e., ≥ 15 eosinophils/HPF).
- - maintain the same diet throughout the duration of the study - female participants must be either: 1.
- - Any past or planned cardiac surgery.
- - An aortic root Z-score ≥ 3.0 on a previous echocardiogram.
- - Intolerance to losartan - A mean blood pressure measurement (both systolic and diastolic) at screening that is below the 2nd percentile for his/her age - Renal dysfunction - Another disorder that causes esophageal eosinophilia (e.g., hypereosinophilic syndrome, Churg Strauss vasculitis, eosinophilic granuloma, or a parasitic infection).
- - A diagnosis of hepatic insufficiency.
- - A history of abnormal gastric or duodenal biopsy or documented gastrointestinal disorders (e.g., Celiac Disease, Crohn's disease or Helicobacter pylori infection), not including chronic gastritis, chronic duodenitis, mucosal eosinophilia or other eosinophilic gastrointestinal disorders (EGIDs).
- - Use of anti-IgE monoclonal antibody (mAb), anti-tumor necrosis factor [TNF] mAb, anti-IL-5 agents, or anti-IL-13 within 6 months prior to study entry - Use of methotrexate, cyclosporine, interferon α, or other systemic immunosuppressive or immunomodulating agents within 3 months prior to the screening visit.
- - A stricture during endoscopy procedure that prevents passage of the endoscope - Taking or is planning to take an angiotensin receptor blocker (ARB), angiotensin-converting enzyme inhibitor (ACEI), beta blocker (BB), or calcium-channel blocker therapy at the screening visit or at any time during the study or has been taking any of these medications for 3 months prior to the screening visit.
- - Taking or planning to take hydrochlorothiazide, digoxin, warfarin, cimetidine, phenobarbital, rifampin, or fluconazole.
- - taking or planning to take potassium supplements or salt substitutes containing potassium.
- - A female participant who is pregnant or nursing or, if of childbearing potential, is not using a medically accepted, effective method of birth control (e.g., condom, oral/injectable/subcutaneous contraceptive, intrauterine device, or sexual abstinence).
- - Participated/participating in any investigative drug or device study within 30 days prior to study entry.
- - Participated/participating in any investigative biologics study within 3 months prior to study entry.
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.
Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.
Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.
Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
|Children's Hospital Medical Center, Cincinnati|
The person who is responsible for the scientific and technical direction of the entire clinical study.
|Marc E Rothenberg, MD, PhD|
|Principal Investigator Affiliation||Children's Hospital Medical Center, Cincinnati|
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
The disease, disorder, syndrome, illness, or injury that is being studied.
|Study Website:||View Trial Website|
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.
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