Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01458418 · ClinicalTrials.gov registry record · NA
A Trial of Montelukast for Maintenance Therapy of Eosinophilic Esophagitis in Children
A NA study, sponsored by Children's Mercy Hospital Kansas City.
- Terminated
- Registry status
- NA
- Development phase
- 4
- Enrollment target
NCT01458418 is a NA study that was terminated before completion, run by Children's Mercy Hospital Kansas City. The registered enrollment target is 4 participants.
The verdict
NCT01458418, a NA study, was terminated before completion, sponsored by Children's Mercy Hospital Kansas City.
- TERMINATED
- Registry status
- NA
- Development phase
- 4 participants
- Enrollment target
Study Summary
Eosinophilic Esophagitis (EE) is a condition where eosinophils (a cell that fights infection) travel to the esophagus (the tube through which food passes to the stomach). These cells do not belong there and can cause pain, soreness, difficulty swallowing and sometimes vomiting. Ways to treat this condition include medicine, not eating some foods, and drinking a specific formula (like milk) without eating any other foods. Doing these things can help fight off EE but these problems can come back when treatment is stopped. If EE symptoms go on for a long time, it can lead to the esophagus becoming narrow and feeling tight when eating and swallowing and surgery may be needed to widen the narrowed area to relieve the sensation of tightening. Montelukast is a medicine that fights off a type of chemical that can be a magnet for eosinophils. People usually take this medicine to help treat their asthma. It is not approved to treat EE. This medication is taken once a day. The purpose of this study is to see if Montelukast, compared to placebo, will help reduce the number of eosinophils in children with EE and help stop the tightening of the esophagus.
Interventions
- DRUG Montelukast
- OTHER placebo
- DRUG 5 mg Montelukast
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 4 participants |
| Start Date | 2011-12 |
| Est. Completion | 2015-02 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01458418
The ClinicalTrials.gov registry entry for NCT01458418 describes a study currently listed as terminated, categorized as NA. The registered enrollment target is 4 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 3 interventions - of which Montelukast is the first listed.
NCT01458418 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01458418 about?
NCT01458418 is a clinical study titled "A Trial of Montelukast for Maintenance Therapy of Eosinophilic Esophagitis in Children". Eosinophilic Esophagitis (EE) is a condition where eosinophils (a cell that fights infection) travel to the esophagus (the tube through which food passes to the stomach). These cells do not belong there and can cause pain, soreness, difficulty swallowing and sometimes vomiting. Ways to treat this c...
What is the current status of trial NCT01458418?
This trial is currently terminated. It is a NA study. The enrollment target is 4 participants. The study started on 2011-12. Estimated completion is 2015-02.
What interventions are being tested in trial NCT01458418?
The interventions under investigation include: Montelukast (DRUG), placebo (OTHER), 5 mg Montelukast (DRUG).
Who is sponsoring clinical trial NCT01458418?
This trial is sponsored by Children's Mercy Hospital Kansas City, which has 184 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.