Trial of Montelukast in Eosinophilic Esophagitis



Status:Completed
Conditions:Gastrointestinal
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:18 - 100
Updated:4/21/2016
Start Date:August 2007
End Date:September 2015

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Trial Summary
Trial Overview
Inclusion Criteria

A Randomized Placebo-Controlled Trial of Montelukast in Maintenance Therapy of Asymptomatic Eosinophilic Esophagitis

Evaluate clinical effectiveness of oral montelukast compared to placebo on prevention of
dysphagia and food impaction in patients with EE.

Also evaluate tolerance and safety of oral montelukast in treatment of EE.

We will randomize in a double blind manner 60 consecutive consenting patients being
evaluated at the three Mayo Clinic Medical Centers with EE to montelukast 20mg daily or
placebo daily for six months? time. Patients will be in remission after treatment with
topical fluticasone therapy before enrollment. Patients will fill out a validated dysphagia
and side effect questionnaire before, during, and at the end of therapy.

Inclusion Criteria:

- 18 years of age or older

- > 14 eosinophils / hpf on biopsies from mid esophagus within the 6 months.

- Abnormal dysphagia questionnaire (Question 1a yes, question 1c >/= mild and question
2 >/= less than once a week) prior to topical steroid treatment. This questionnaire
has recently been validated.

- Normal dysphagia questionnaire after topical steroid treatment (Having an answer of
no to question 1a: Have you had trouble swallowing, not associated with other cold
symptoms? over the past two weeks since having completed the swallowed steroid
treatment).
We found this trial at
1
site
The Mayo Clinic
Rochester, Minnesota 55905
?
mi
from
Rochester, MN
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