Montelukast in the Treatment of Duodenal Eosinophilia

This study is currently recruiting participants.

Verified by Children's Mercy Hospital Kansas City, September 2005

First Received: September 6, 2005 Last Updated: September 22, 2006 History of Changes

Sponsor:	Children's Mercy Hospital Kansas City
Collaborator:	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

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

Resource links provided by NLM:

MedlinePlus related topics: Eosinophilic Disorders Gastroenteritis Indigestion

Drug Information available for: Montelukast sodium Montelukast

U.S. FDA Resources

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

No publications provided by Children's Mercy Hospital Kansas City

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

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.

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

Keywords provided by Children's Mercy Hospital Kansas City:

dyspepsia
eosinophilic gastroenteritis
montelukast

Additional relevant MeSH terms:

Respiratory System Agents
Signs and Symptoms, Digestive
Gastrointestinal Diseases
Hormone Antagonists
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Leukocyte Disorders
Leukotriene Antagonists
Signs and Symptoms
Therapeutic Uses
Parasitic Diseases
Helminthiasis
Ascaridida Infections

Hematologic Diseases
Anti-Asthmatic Agents
Nematode Infections
Dyspepsia
Intestinal Diseases
Eosinophilia
Pharmacologic Actions
Montelukast
Digestive System Diseases
Anisakiasis
Intestinal Diseases, Parasitic
Gastroenteritis
Secernentea Infections

ClinicalTrials.gov processed this record on February 04, 2010