Montelukast in the Treatment of Duodenal Eosinophilia

This study has been completed.
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by:
Children's Mercy Hospital Kansas City
ClinicalTrials.gov Identifier:
NCT00148603
First received: September 6, 2005
Last updated: December 26, 2011
Last verified: December 2011
  Purpose

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.


Condition Intervention
Eosinophilic Gastroenteritis
Dyspepsia
Drug: montelukast

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind
Primary Purpose: Treatment
Official Title: Montelukast in the Treatment of Duodenal Eosinophilia in Children With Dyspepsia: Effect on Eosinophil Density and Activation in Relation to Pharmacokinetics

Resource links provided by NLM:


Further study details as provided by Children's Mercy Hospital Kansas City:

Primary Outcome Measures:
  • eosinophil density
  • eosinophil activation
  • mast cell density
  • serum eosinophil cationic protein

Secondary Outcome Measures:
  • serum montelukast concentration
  • duodenal mucosa montelukast concentration

Estimated Enrollment: 24
Study Start Date: September 2005
Study Completion Date: December 2006
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   8 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00148603

Locations
United States, Missouri
Children's Mercy Hospital and Clinics
Kansas City, Missouri, United States, 64108
Sponsors and Collaborators
Children's Mercy Hospital Kansas City
Merck Sharp & Dohme Corp.
Investigators
Principal Investigator: Craig A Friesen Children's Mercy Hospital and Clinics
  More Information

No publications provided by Children's Mercy Hospital Kansas City

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00148603     History of Changes
Other Study ID Numbers: 05 01-009
Study First Received: September 6, 2005
Last Updated: December 26, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Children's Mercy Hospital Kansas City:
dyspepsia
eosinophilic gastroenteritis
montelukast

Additional relevant MeSH terms:
Dyspepsia
Enteritis
Eosinophilia
Eosinophilic Esophagitis
Gastritis
Gastroenteritis
Digestive System Diseases
Esophageal Diseases
Esophagitis
Gastrointestinal Diseases
Hematologic Diseases
Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Intestinal Diseases
Leukocyte Disorders
Signs and Symptoms
Signs and Symptoms, Digestive
Stomach Diseases
Montelukast
Anti-Asthmatic Agents
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Leukotriene Antagonists
Pharmacologic Actions
Physiological Effects of Drugs
Respiratory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014