Montelukast in the Treatment of Duodenal Eosinophilia

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00148603
• Date of registration: 06/09/2005
• Prospective Registration: No
• Primary sponsor: Children's Mercy Hospital Kansas City
• Public title: Montelukast in the Treatment of Duodenal Eosinophilia
• Scientific title: Montelukast in the Treatment of Duodenal Eosinophilia in Children With Dyspepsia: Effect on Eosinophil Density and Activation in Relation to Pharmacokinetics
• Date of first enrolment: September 2005
• Target sample size: 24
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00148603
• Study type: Interventional
• Study design: Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind, Primary Purpose: Treatment
• Phase: N/A

Countries of recruitment

United States

Contacts

• Name: Craig A Friesen
• Affiliation: Children's Mercy Hospital and Clinics

Key inclusion & exclusion 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



Age minimum: 8 Years
Age maximum: 17 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Eosinophilic Gastroenteritis

Dyspepsia

Intervention(s)

Drug: montelukast

Primary Outcome(s)

eosinophil activation

serum eosinophil cationic protein

mast cell density

eosinophil density

Secondary Outcome(s)

serum montelukast concentration

duodenal mucosa montelukast concentration

Secondary ID(s)

05 01-009

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Merck Sharp & Dohme Corp.