Montelukast in the Treatment of Duodenal Eosinophilia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00148603
Recruitment Status : Completed
First Posted : September 8, 2005
Last Update Posted : December 29, 2011
Merck Sharp & Dohme Corp.
Information provided by:
Children's Mercy Hospital Kansas City

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.

Condition or disease Intervention/treatment Phase
Eosinophilic Gastroenteritis Dyspepsia Drug: montelukast Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Single
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
Study Start Date : September 2005
Actual Study Completion Date : December 2006

Resource links provided by the National Library of Medicine

Drug Information available for: Montelukast

Primary Outcome Measures :
  1. eosinophil density
  2. eosinophil activation
  3. mast cell density
  4. serum eosinophil cationic protein

Secondary Outcome Measures :
  1. serum montelukast concentration
  2. duodenal mucosa montelukast concentration

Information from the National Library of Medicine

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Ages Eligible for Study:   8 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00148603

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.
Principal Investigator: Craig A Friesen Children's Mercy Hospital and Clinics

Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00148603     History of Changes
Other Study ID Numbers: 05 01-009
First Posted: September 8, 2005    Key Record Dates
Last Update Posted: December 29, 2011
Last Verified: December 2011

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

Additional relevant MeSH terms:
Eosinophilic Esophagitis
Signs and Symptoms, Digestive
Signs and Symptoms
Gastrointestinal Diseases
Digestive System Diseases
Leukocyte Disorders
Hematologic Diseases
Esophageal Diseases
Hypersensitivity, Immediate
Immune System Diseases
Intestinal Diseases
Stomach Diseases
Anti-Asthmatic Agents
Respiratory System Agents
Leukotriene Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Cytochrome P-450 CYP1A2 Inducers
Cytochrome P-450 Enzyme Inducers
Molecular Mechanisms of Pharmacological Action