Montelukast in the Treatment of Duodenal Eosinophilia

• Status: Completed
• Trial end date: 2006-12-01
• Target enrollment: 0
• Participant gender: All

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 eosinophilia in association with measuring the concentration of the medication in the lining of the duodenum. Patients will be endoscoped with biopsies obtained from the duodenum as part of routine clinical care. Participants in the study will then receive montelukast daily and the endoscopy with biopsies will be repeated on day 21 to measure cell counts and activation and tissue montelukast levels. Cell counts and measures of activation will be compared to pre-treatment levels.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Children's Mercy Hospital Kansas City
• Collaborator: Merck Sharp & Dohme Corp.
• Treatments: Montelukast

Criteria

Inclusion Criteria:

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 Criteria:

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