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Sponsors and Collaborators: |
Children's Mercy Hospital Kansas City Merck |
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Information provided by: | Children's Mercy Hospital Kansas City |
ClinicalTrials.gov Identifier: | NCT00148603 |
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 |
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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 |
Estimated Enrollment: | 24 |
Study Start Date: | September 2005 |
Estimated Study Completion Date: | September 2006 |
Ages Eligible for Study: | 8 Years to 17 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
A subject will be eligible for inclusion in this study if all of the following criteria are met:
Exclusion Criteria:
Subjects will not be eligible for inclusion in this study if any of the following criteria apply:
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 |
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 |
Principal Investigator: | Craig A Friesen | Children's Mercy Hospital and Clinics |
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 |
dyspepsia eosinophilic gastroenteritis montelukast |
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 |
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 |