Trial of Montelukast in Eosinophilic Esophagitis

Phase 1

Completed

• Conditions: Eosinophilic Esophagitis
• Interventions: Drug: Placebo; Drug: Montelukast/ Singulair

• Registration Number: NCT00511316
• Lead Sponsor: Mayo Clinic

Brief 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.

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.

Study Timeline

• Study Start: 2007-08
• Study First Submitted: 2007-08-01
• Study First Submitted QC: 2007-08-02
• Study First Posted: 2007-08-03
• Primary Completion: 2015-09
• Study Completion: 2015-09
• Status Verified: 2015-11
• Last Update Submitted: 2015-11-02
• Last Update Posted: 2015-11-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 41

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).

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	20 mg daily placebo
Drug	Montelukast/ Singulair	20 mg montelukast daily for 6 months

Primary Outcome Measures

Name	Time	Method
evaluate effectiveness of oral montelukast in treatment of EE.	6 months

Secondary Outcome Measures

Name	Time	Method
evaluate safety of montelukast in eosinophilic esophagitis	6 months

Trial Locations

Locations (1)

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States