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

Stopped early · Not applicable · Has a placebo group

Conditions studied: Eosinophilic Esophagitis

In brief

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.

Key facts

Study ID

NCT01458418

Run by

Children's Mercy Hospital Kansas City

People needed

4

Starts

2011-12-01

Expected to finish

2015-02-01

Last updated by the study team

2020-10-30

Who can join

Age: 2 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Males and females aged 2-17
• Presence of more than 15 eosinophils per hpf on original endoscopy and less than 5 eosinophils/hpf on the most recent endoscopy
• Concurrent PPI for 1 month at 1-2mg/kg/dose prior to endoscopy or have a negative pH study
• English speaking
• Ability to undergo a follow up endoscopy between 12 and 13 weeks after the start of the study
• Procurement of written informed consent signed by the subject's legal guardian and study investigator (s) and subject assent.

You may not qualify if…

• Subjects with eosinophils in stomach and duodenum on original endoscopy.
• Subjects requiring oral prednisone within 1 month of current endoscopy.
• Subjects with diagnosis of other co-morbid diseases such as heart disease, renal disease, autoimmune disease, an immunodeficiency, diabetes, phenylketonuria, or thyroid disease.
• Subjects using Montelukast within one month of current endoscopy
• Subjects with concurrent use of phenobarbital or rifampin

Where it is running

• Children's Mercy Hospitals and Clinics — Kansas City, Missouri, United States

Full record on ClinicalTrials.gov

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