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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT04248712
Other study ID # 19-005510
Secondary ID
Status Terminated
Phase Phase 2
First received
Last updated
Start date July 10, 2020
Est. completion date December 31, 2021

Study information

Verified date November 2022
Source Mayo Clinic
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Researchers are assessing the safety and effectiveness of antihistamines in the treatment of eosinophilic esophagitis.


Description:

The purpose of this research is to determine if antihistamines are safe and effective for the treatment of eosinophilic esophagitis. Antihistamines are frequently used for the treatment of gastroesophageal reflux disease and allergic disorders, and we hypothesize they will be effective in the treatment of eosinophilic esophagitis as well. The two antihistamines used in this study are loratadine and famotidine.


Recruitment information / eligibility

Status Terminated
Enrollment 1
Est. completion date December 31, 2021
Est. primary completion date December 31, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Patients over the age of 18, male and female. - 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: - Not willing or able to sign consent. - 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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
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

Locations

Country Name City State
United States Mayo Clinic Jacksonville Florida

Sponsors (1)

Lead Sponsor Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Adverse Events Number of adverse events reported 12 weeks
Primary Change in Maximum Eosinophil Count Calculated by maximum eosinophils per esophagogastroduodenoscopy (EGD) high-power field (eos/hpf) after therapy with antihistamines. As measured by the percentage of change in maximum eosinophil count from baseline to 12 weeks. 12 weeks
Secondary Change in Symptoms of Eosinophilic Esophagitis, as Measured by Dysphagia Symptom Questionnaire Measured by the self-reported Dysphagia Symptom Questionnaire (DSQ). The DSQ ranges from 0 to 10, with a lower score indicating less symptoms and a higher score indicating more symptoms. 12 weeks
Secondary Change in Endoscopic Response, as Measured by the Endoscopic Reference Score Percentage of subjects with endoscopic response as measured by the Eosinophilic Esophagitis (EoE) Endoscopic Reference Score (EREFS). The score ranges from 0 to 10, with a higher score indicating worse endoscopic findings of eosinophilic esophagitis. 12 weeks
Secondary Change in Histologic Response Percentage of subjects with histologic response of =15 eos/hpf on biopsy at the lower and mid esophagus 12 weeks
See also
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