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Main
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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. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT01808196 |
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Date of registration:
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30/01/2013 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Testing Effectiveness of Losartan in Patients With EoE With or Without a CTD
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Scientific title:
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A Preliminary, Open-label Trial of Losartan Potassium in Participants With Eosinophilic Esophagitis (EoE) With or Without a Connective Tissue Disorder. |
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Date of first enrolment:
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October 10, 2013 |
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Target sample size:
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6 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT01808196 |
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Study type:
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Interventional |
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Study design:
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Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 2
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Countries of recruitment
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United States
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Contacts
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Name:
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J. Pablo Abonia, M.D. |
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Address:
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Telephone:
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Email:
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Affiliation:
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Children's Hospital Medical Center, Cincinnati |
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Name:
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Marc E Rothenberg, M.D., Ph.D. |
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Address:
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Telephone:
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Email:
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Affiliation:
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Children's Hospital Medical Center, Cincinnati |
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Key inclusion & exclusion criteria
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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
documentation)
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
control.
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
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Health Condition(s) or Problem(s) studied
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Connective Tissue Disorders
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Eosinophilic Esophagitis
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Intervention(s)
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Drug: Losartan Potassium
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Primary Outcome(s)
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Percent of Participants in Histologic Remission at 16 Weeks
[Time Frame: 16 weeks after treatment]
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Secondary Outcome(s)
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Change in Peak Eosinophil Count at 16 Weeks
[Time Frame: Baseline, 16 weeks after treatment]
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Change in Pediatric EoE Symptom Score at 16 Weeks
[Time Frame: Baseline, 16 weeks after treatment]
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Secondary ID(s)
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2012-0106
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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