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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: Clinical Trial NA study, sponsored by Children's Mercy Hospital Kansas City.
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, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (100% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Eosinophils/high powered field(hpf) in the mid esophagus will be measured after 12 weeks of therapy.
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 |
Why NCT01458418 stopped before completion
NCT01458418 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 4 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (100% lower).
The record links to 0 conditions, and to 3 interventions - of which Montelukast is the first listed.
NCT01458418 does not publish any study locations in the registry export this page uses.
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
How this trial's enrollment target compares
Where NCT01458418's enrollment target sits among peer trials
4 1996th of 2000 higher than 5 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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