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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: Completed study, sponsored by Children's Mercy Hospital Kansas City.
NCT02360696 is a clinical trial that has completed, run by Children's Mercy Hospital Kansas City. The registered enrollment target is 18 participants. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Identification of patients who will benefit from montelukast therapy , allowing more efficient, and possibly more effective, care.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2014-08 |
| Est. Completion | 2016-08 |
What the finished NCT02360696 record still lists
NCT02360696 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 18 participants, a relatively small participant target.
The record links to 0 conditions, and to 0 interventions.
NCT02360696 does not publish any study locations in the registry export this page uses.
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.
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