Trial of Montelukast in Eosinophilic Esophagitis
Information source: Mayo Clinic
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Eosinophilic Esophagitis
Intervention: Montelukast/ Singulair (Drug); Placebo (Drug)
Phase: Phase 1
Status: Recruiting
Sponsored by: Mayo Clinic Official(s) and/or principal investigator(s):
Jeffery A. Alexander, M.D., Principal Investigator, Affiliation: Mayo Clinic
Summary
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.
Clinical Details
Official title: A Randomized Placebo-Controlled Trial of Montelukast in Maintenance Therapy of Asymptomatic Eosinophilic Esophagitis
Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Single Group Assignment, Safety/Efficacy Study
Primary outcome: evaluate effectiveness of oral montelukast in treatment of EE.
Secondary outcome: evaluate safety of montelukast in eosinophilic esophagitis
Detailed description:
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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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).
Locations and Contacts
Mayo Clinic, Rochester, Minnesota 55905, United States; Recruiting
Julie A. Schreiber, Phone: 507-266-9138, Email: schreiber.julie@mayo.edu
Jeffery A. Alexander, M.D., Principal Investigator
Additional Information
Mayo Clinic Clinical Trials
Starting date: August 2007
Ending date: July 2009
Last updated: July 20, 2009
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