Montelukast in the Treatment of Duodenal Eosinophilia

NCT00148603 | Completed

• 1 other identifier: 05 01-009
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Eosinophilic Gastroenteritis; Dyspepsia

Keywords

dyspepsia; eosinophilic gastroenteritis; montelukast

Outcome Measures

Primary Outcomes (4)

• eosinophil density

• eosinophil activation

• mast cell density

• serum eosinophil cationic protein

Secondary Outcomes (2)

• serum montelukast concentration

• duodenal mucosa montelukast concentration

Interventions

montelukast DRUG

Eligibility Criteria

• Age: 8 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Children's Mercy Hospital Kansas City: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (1)

Children's Mercy Hospital and Clinics

Kansas City, Missouri, 64108, United States

Location

Related Publications (1)

• Friesen CA, Neilan NA, Schurman JV, Taylor DL, Kearns GL, Abdel-Rahman SM. Montelukast in the treatment of duodenal eosinophilia in children with dyspepsia: effect on eosinophil density and activation in relation to pharmacokinetics. BMC Gastroenterol. 2009 May 11;9:32. doi: 10.1186/1471-230X-9-32.

  PMID: 19432972 DERIVED

MeSH Terms

Conditions

Eosinophilic enteropathy; Dyspepsia

Interventions

montelukast

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Craig A Friesen

  Children's Mercy Hospital and Clinics

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 6, 2005
• First Posted: September 8, 2005
• Study Start: September 1, 2005
• Study Completion: December 1, 2006
• Last Updated: December 29, 2011

Record last verified: 2011-12

Locations

US (1)