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Montelukast in the Treatment of Duodenal Eosinophilia
This study is currently recruiting participants.
Verified by Children's Mercy Hospital Kansas City, September 2005
Sponsors and Collaborators: Children's Mercy Hospital Kansas City
Merck
Information provided by: Children's Mercy Hospital Kansas City
ClinicalTrials.gov Identifier: NCT00148603
  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

MedlinePlus related topics: Eosinophilic Disorders Gastroenteritis Indigestion
Drug Information available for: Montelukast sodium Montelukast
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Single Blind, Uncontrolled, Single Group Assignment, Efficacy Study
Official Title: Montelukast in the Treatment of Duodenal Eosinophilia in Children With Dyspepsia: Effect on Eosinophil Density and Activation in Relation to Pharmacokinetics

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
Estimated Study Completion Date: September 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00148603

Contacts
Contact: Andre Linda, RN,BSN 816-234-3000 ext 1058 landre@cmh.edu
Contact: Friesen A Friesen, MD 816-234-3000 ext 3016 cfriesen@cmh.edu

Locations
United States, Missouri
Children's Mercy Hospital and Clinics Recruiting
Kansas City, Missouri, United States, 64108
Contact: William Caskey, PhD     816-234-3000 ext 3874     wcaskey@cmh.edu    
Principal Investigator: Craig A Friesen, MD            
Sub-Investigator: Gregory L Kearns, PhD            
Sub-Investigator: Susan M Abdel-Rahman, PhD            
Sub-Investigator: Jennifer V Schurman, PhD            
Sub-Investigator: Linda Andre, RN            
Sponsors and Collaborators
Children's Mercy Hospital Kansas City
Merck
Investigators
Principal Investigator: Craig A Friesen Children's Mercy Hospital and Clinics
  More Information

Study ID Numbers: 05 01-009
Study First Received: September 6, 2005
Last Updated: September 22, 2006
ClinicalTrials.gov Identifier: NCT00148603  
Health Authority: United States: Institutional Review Board

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

Study placed in the following topic categories:
Signs and Symptoms, Digestive
Hematologic Diseases
Gastrointestinal Diseases
Leukocyte Disorders
Nematode Infections
Eosinophilic enteropathy
Intestinal Diseases
Dyspepsia
Eosinophilia
Leukotriene Antagonists
Montelukast
Signs and Symptoms
Digestive System Diseases
Parasitic Diseases
Intestinal Diseases, Parasitic
Anisakiasis
Gastroenteritis
Helminthiasis

Additional relevant MeSH terms:
Ascaridida Infections
Respiratory System Agents
Therapeutic Uses
Hormone Antagonists
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Anti-Asthmatic Agents
Pharmacologic Actions
Secernentea Infections

ClinicalTrials.gov processed this record on January 16, 2009