NCT00511316

Trial of Montelukast in Eosinophilic Esophagitis

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 41 (actual)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Accepted

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.

Conditions

• Eosinophilic Esophagitis

Interventions

Type	Name	Description
DRUG	Montelukast/ Singulair	20 mg daily for six months
DRUG	Placebo	Placebo 20 mg daily for 6 months

Timeline

• Start date: 2007-08-01
• Primary completion: 2015-09-01
• Completion: 2015-09-01
• First posted: 2007-08-03
• Last updated: 2015-11-03

Locations

1 site across 1 country: United States