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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Last refreshed on: 12 December 2020
Main ID:  NCT01808196
Date of registration: 30/01/2013
Prospective Registration: Yes
Primary sponsor: Children's Hospital Medical Center, Cincinnati
Public title: Testing Effectiveness of Losartan in Patients With EoE With or Without a CTD
Scientific title: A Preliminary, Open-label Trial of Losartan Potassium in Participants With Eosinophilic Esophagitis (EoE) With or Without a Connective Tissue Disorder.
Date of first enrolment: October 10, 2013
Target sample size: 6
Recruitment status: Completed
Study type:  Interventional
Study design:  Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).  
Phase:  Phase 2
Countries of recruitment
United States
Name:     J. Pablo Abonia, M.D.
Affiliation:  Children's Hospital Medical Center, Cincinnati
Name:     Marc E Rothenberg, M.D., Ph.D.
Affiliation:  Children's Hospital Medical Center, Cincinnati
Key inclusion & exclusion criteria

Inclusion Criteria:

1. Confirmed diagnosis of eosinophilic esophagitis.

2. Have been on a high dose proton pump inhibitor for at least 8 weeks prior to a
diagnostic endoscopy of eosinophilic esophagitis without histologic resolution.

3. Agree to maintain the same diet throughout the duration of the study.

4. If participant is female: meet one of the following criteria:

1. Is of non-childbearing potential (pre-menarchal or surgically sterile with

2. Is of childbearing potential with a negative urine pregnancy test at screening.

Exclusion Criteria:

1. Past or planned cardiac surgeries.

2. Had an aortic root Z-score greater than 3 on a previous echocardiogram.

3. Have intolerance to the study agent such as angioedema, IgE-mediated allergy.

4. Have renal dysfunction with creatinine in excess of the upper normal limit for age.

5. Have another disorder that causes esophageal eosinophilia (e.g., hypereosinophilic
syndrome, Churg Strauss vasculitis, eosinophilic granuloma, or a parasitic infection).

6. Diagnosed with hepatic insufficiency.

7. History of abnormal gastric or duodenal biopsy or documented gastrointestinal (GI)
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.

8. Used anti-immunoglobulin E [IgE] mAb, anti-tumor necrosis factor [TNF] mAb, anti-IL-5
agents, or anti-IL-13 within the last six months.

9. Used methotrexate, cyclosporine, interferon-a, or other systemic immunosuppressive or
immunomodulating agents within the last three months.

10. Have a history of a stricture during an endoscopy procedure that prevents passage of
the endoscope.

11. Taking or plan to take an angiotensin II receptor blocker (ARB) therapy,
angiotensin-converting enzyme inhibitor (ACEI), beta blocker therapy (BB), or calcium
channel blocker at the screening visit or at any time during the study, or have you
been taking any of these medications for the last three months.

12. If the participant is female: pregnant or nursing.

13. Taking any investigative drug or device study within the last 30 days.

14. Had participated in any investigative biologics study within the last three months
prior to the study entry.

15. Taking or plan to take hydrochlorothiazide, warfarin, cimetidine, phenobarbital,
rifampin, or fluconazole.

16. If the participant is female: using a medically accepted effective method of birth

17. Will be able to complete all study procedures including endoscopy.

18. Taking or plan to take potassium supplements or salt substitutes containing potassium.

Age minimum: 5 Years
Age maximum: 21 Years
Gender: All
Health Condition(s) or Problem(s) studied
Connective Tissue Disorders
Eosinophilic Esophagitis
Drug: Losartan Potassium
Primary Outcome(s)
Percent of Participants in Histologic Remission at 16 Weeks [Time Frame: 16 weeks after treatment]
Secondary Outcome(s)
Change in Peak Eosinophil Count at 16 Weeks [Time Frame: Baseline, 16 weeks after treatment]
Change in Pediatric EoE Symptom Score at 16 Weeks [Time Frame: Baseline, 16 weeks after treatment]
Secondary ID(s)
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results available: Yes
Date Posted: 24/09/2020
Date Completed:
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