Status:
COMPLETED
Montelukast in the Treatment of Duodenal Eosinophilia
Lead Sponsor:
Children's Mercy Hospital Kansas City
Collaborating Sponsors:
Merck Sharp & Dohme LLC
Conditions:
Eosinophilic Gastroenteritis
Dyspepsia
Eligibility:
All Genders
8-17 years
Phase:
NA
Brief Summary
This is a single site study of the effect of montelukast on eosinophil and mast cell counts and activation in the lining of the duodenum in 24 children with dyspepsia in association with duodenal eosi...
Detailed Description
I. Background/Rationale Recurrent abdominal pain is a common complaint among school-age children, being present in up to 15% at any given time. It represents the most common chronic pain entity in pe...
Eligibility Criteria
Inclusion
- A subject will be eligible for inclusion in this study if all of the following criteria are met:
- Patients with dyspepsia defined as upper abdominal pain or discomfort of at least two months duration.
- Male and female subjects 6 - 17 years of age
- Endoscopic mucosal biopsies revealing at least 20 eosinophils in a high power field on specimens from the duodenum in the absence of other defined duodenal pathology.
- Written informed consent signed by the subject's legal guardian and by the investigator and patient assent.
Exclusion
- Subjects will not be eligible for inclusion in this study if any of the following criteria apply:
- A subject who has previously been treated with montelukast.
- Treatment with steroids or oral cromolyn in the four weeks prior to endoscopy or during the study.
- Any history, clinical, and/or biochemical evidence of clinically significant renal or liver disease.
- Treatment with any inducers or inhibitors of CYP3A4.
- Intake of grapefruit juice or oral vitamin E supplementation
Key Trial Info
Start Date :
September 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2006
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT00148603
Start Date
September 1 2005
End Date
December 1 2006
Last Update
December 29 2011
Active Locations (1)
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1
Children's Mercy Hospital and Clinics
Kansas City, Missouri, United States, 64108