Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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TERMINATED
PHASE2
1 participants
INTERVENTIONAL
2020-07-10
2021-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Treatment Group
Participants receive Famotidine 40 mg tab twice daily by mouth and Loratadine 10 mg tab once daily by mouth for 12 weeks.
Famotidine
40 mg tab twice daily by mouth for 12 week duration
Loratadine
10 mg tab once daily by mouth for 12 week duration
Placebo Group
Participants receive Famotidine placebo tablet matching Famotidine orally twice daily for 12 weeks, and Loratadine placebo tablet matching Loratadine orally daily for 12 weeks.
Placebo
Contains no active ingredient
Interventions
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Famotidine
40 mg tab twice daily by mouth for 12 week duration
Loratadine
10 mg tab once daily by mouth for 12 week duration
Placebo
Contains no active ingredient
Eligibility Criteria
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Inclusion Criteria
* Patients who carry the diagnosis of Eosinophilic Esophagitis (EoE) based on esophageal biopsies obtained within 6 months prior to enrollment (\>15 eosinophils per hpf on at least 2 esophageal levels)
* Subjects must be able to give appropriate informed consent
Exclusion Criteria
* Patients who have used topical or systemic corticosteroid therapy for any reason in the previous 6 weeks.
* Patients who have been treated with acid-suppressing medications (PPI or H2 receptor antagonists) in the previous 6 weeks.
* Patients on immunosuppressive or immunomodulating medications in the previous 6 weeks.
* Patients with known allergies or hypersensitivity to anti-histamines.
* Patients who have contraindications to the procurement of esophageal biopsies including patients who have known bleeding disorders, a history of bleeding diathesis, or who are currently using warfarin or clopidogrel.
* Patients who have a contraindication to the performance of an esophagogastroduodenoscopy (EGD) including previous cardiopulmonary arrest during an endoscopic procedure.
* Patients who are pregnant.
18 Years
ALL
No
Sponsors
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Mayo Clinic
OTHER
Responsible Party
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Dawn Francis
Principal Investigator
Principal Investigators
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Dawn Francis, MD
Role: PRINCIPAL_INVESTIGATOR
Mayo Clinic
Locations
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Mayo Clinic
Jacksonville, Florida, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Related Links
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Mayo Clinic Clinical Trials
Other Identifiers
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19-005510
Identifier Type: -
Identifier Source: org_study_id