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Terminated Not applicable Interventional Results available

A Trial of Montelukast for Maintenance Therapy of Eosinophilic Esophagitis in Children

ClinicalTrials.gov ID: NCT01458418

Public ClinicalTrials.gov record NCT01458418. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 25, 2026, 4:15 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT01458418
Recruitment status
Terminated
Study type
Interventional
Phase
Not applicable
Enrollment
4 participants

Conditions and interventions

Interventions

Drug · Other

Eligibility (public fields only)

Age range
2 Years to 17 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Nov 30, 2011
Primary completion
Jan 31, 2015
Completion
Jan 31, 2015
Last update posted
Oct 29, 2020

2011 – 2015

United States locations

U.S. sites
1
U.S. states
1
U.S. cities
1
Facility City State ZIP Site status
Children's Mercy Hospitals and Clinics Kansas City Missouri 64108 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT01458418, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Oct 29, 2020 · Synced Sep 25, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT01458418 live on ClinicalTrials.gov.

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