Montelukast in the Treatment of Duodenal Eosinophilia
This study has been completed.
Sponsor:
Children's Mercy Hospital Kansas City
Collaborator:
Merck
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
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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
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
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 Eosinophilia Gastroenteritis Eosinophilic Esophagitis Enteritis Gastritis Signs and Symptoms, Digestive Signs and Symptoms Leukocyte Disorders Hematologic Diseases Gastrointestinal Diseases Digestive System Diseases Esophagitis Esophageal Diseases |
Hypersensitivity, Immediate Hypersensitivity Immune System Diseases Intestinal Diseases Stomach Diseases Montelukast Leukotriene Antagonists Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Pharmacologic Actions Anti-Asthmatic Agents Respiratory System Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 22, 2013