Status:
TERMINATED
A Trial of Montelukast for Maintenance Therapy of Eosinophilic Esophagitis in Children
Lead Sponsor:
Children's Mercy Hospital Kansas City
Conditions:
Eosinophilic Esophagitis
Eligibility:
All Genders
2-17 years
Phase:
NA
Brief Summary
Eosinophilic Esophagitis (EE) is a condition where eosinophils (a cell that fights infection) travel to the esophagus (the tube through which food passes to the stomach). These cells do not belong the...
Detailed Description
Eosinophilic esophagitis (EE) is a disease diagnosed using both clinical and pathologic results. Presentation varies among age groups with younger children suffering from vomiting, failure to thrive, ...
Eligibility Criteria
Inclusion
- Males and females aged 2-17
- Presence of more than 15 eosinophils per hpf on original endoscopy and less than 5 eosinophils/hpf on the most recent endoscopy
- Concurrent PPI for 1 month at 1-2mg/kg/dose prior to endoscopy or have a negative pH study
- English speaking
- Ability to undergo a follow up endoscopy between 12 and 13 weeks after the start of the study
- Procurement of written informed consent signed by the subject's legal guardian and study investigator (s) and subject assent.
Exclusion
- Subjects with eosinophils in stomach and duodenum on original endoscopy.
- Subjects requiring oral prednisone within 1 month of current endoscopy.
- Subjects with diagnosis of other co-morbid diseases such as heart disease, renal disease, autoimmune disease, an immunodeficiency, diabetes, phenylketonuria, or thyroid disease.
- Subjects using Montelukast within one month of current endoscopy
- Subjects with concurrent use of phenobarbital or rifampin
Key Trial Info
Start Date :
December 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2015
Estimated Enrollment :
4 Patients enrolled
Trial Details
Trial ID
NCT01458418
Start Date
December 1 2011
End Date
February 1 2015
Last Update
October 30 2020
Active Locations (1)
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1
Children's Mercy Hospitals and Clinics
Kansas City, Missouri, United States, 64108