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NCT02360696 · ClinicalTrials.gov registry record

Functional Dyspepsia (FD) - Clinical Response to Montelukast in Children

A clinical trial, sponsored by Children's Mercy Hospital Kansas City.

Completed
Registry status
18
Enrollment target

NCT02360696 is a clinical trial that has completed, run by Children's Mercy Hospital Kansas City. The registered enrollment target is 18 participants.

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The verdict

NCT02360696 has completed, sponsored by Children's Mercy Hospital Kansas City.

COMPLETED
Registry status
18 participants
Enrollment target

Study Summary

Duodenal eosinophilia has been associated with dyspepsia in adults and the investigators have previously described the finding of duodenal mucosal eosinophilia in 71-79% of children undergoing diagnostic endoscopy. Previous studies in children have shown positive response to montelukast with approximately 50% finding complete relief and 20-30 percent showing no response. There are a number of factors that have the potential to contribute to the observed variability in response to montelukast. These include variability in: 1. systemic drug exposure (drug absorption, biotransformation and/or elimination) 2. regulation of leukotriene biosynthesis 3. cysteinyl leukotriene receptors and downstream mediators 4. patient disease phenotype (e.g. Functional Gastrointestinal Disorder (FGID) disease classification, psychologic profile) In this study, the investigators propose to utilize biopsy specimens stratified by drug response to identify candidate gene expression modules that will be validated in a prospective study design. The overall goal of this program is to develop a signature of montelukast response that can be applied not only to eosinophilic gastroenteritis, but more generally to other diseases, such as asthma, where the drug is widely used with variable success.

Trial Details

FieldValue
Enrollment Target 18 participants
Start Date 2014-08
Est. Completion 2016-08

What the Registry Record Tells You About NCT02360696

The ClinicalTrials.gov registry entry for NCT02360696 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 18 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Children's Mercy Hospital Kansas City, which has 184 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 0 interventions.

NCT02360696 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT02360696 about?

NCT02360696 is a clinical study titled "Functional Dyspepsia (FD) - Clinical Response to Montelukast in Children". Duodenal eosinophilia has been associated with dyspepsia in adults and the investigators have previously described the finding of duodenal mucosal eosinophilia in 71-79% of children undergoing diagnostic endoscopy. Previous studies in children have shown positive response to montelukast with approxi...

What is the current status of trial NCT02360696?

This trial is currently completed. The enrollment target is 18 participants. The study started on 2014-08. Estimated completion is 2016-08.

Who is sponsoring clinical trial NCT02360696?

This trial is sponsored by Children's Mercy Hospital Kansas City, which has 184 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

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