Antihistamines in Eosinophilic Esophagitis (ATEE)
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|ClinicalTrials.gov Identifier: NCT04248712|
Recruitment Status : Recruiting
First Posted : January 30, 2020
Last Update Posted : August 19, 2020
|Condition or disease||Intervention/treatment||Phase|
|Eosinophilic Esophagitis||Drug: Famotidine Drug: Loratadine Drug: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||A Phase II, Randomized, Placebo-controlled Study Evaluating the Efficacy of Antihistamines in the Treatment of Eosinophilic Esophagitis (the ATEE Study)|
|Actual Study Start Date :||July 10, 2020|
|Estimated Primary Completion Date :||December 31, 2021|
|Estimated Study Completion Date :||December 31, 2021|
Experimental: Treatment Group
Participants receive Famotidine 40 mg tab twice daily by mouth and Loratadine 10 mg tab once daily by mouth for 12 weeks.
40 mg tab twice daily by mouth for 12 week duration
10 mg tab once daily by mouth for 12 week duration
Placebo Comparator: 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.
Contains no active ingredient
- Adverse Events [ Time Frame: 12 weeks ]Number of adverse events reported
- Change in maximum eosinophil count [ Time Frame: 12 weeks ]Calculated by maximum eosinophils per high-power field (eos/hpf) after therapy with antihistamines.
- Change in symptoms of eosinophilic esophagitis, as measured by Dysphagia Symptom Questionnaire [ Time Frame: 12 weeks ]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.
- Change in endoscopic response, as measured by the Endoscopic reference score [ Time Frame: 12 weeks ]Percentage of subjects with endoscopic response as measured by the EoE Endoscopic Reference Score (EREFS). The score ranges from 0 to 10, with a higher score indicating worse endoscopic findings of eosinophilic esophagitis.
- Change in histologic response [ Time Frame: 12 weeks ]Percentage of subjects with histologic response of ≤15 eos/hpf on biopsy at the lower and mid esophagus
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04248712
|Contact: Bianca Axenfeld||904-953-3907||Axenfeld.Bianca@mayo.edu|
|United States, Florida|
|Jacksonville, Florida, United States, 32224|
|Principal Investigator:||Dawn Francis, MD||Mayo Clinic|