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NCT00511316 Clinical Trial

Trial of Montelukast in Eosinophilic Esophagitis

Eosinophilic Esophagitis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00511316
Other study ID # 06-003373
Secondary ID
Status Completed
Phase Phase 1
First received August 1, 2007
Last updated November 2, 2015
Start date August 2007
Est. completion date September 2015

Study information
Verified date November 2015
Source Mayo Clinic
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 41
Est. completion date September 2015
Est. primary completion date September 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 100 Years
Eligibility 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).

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Montelukast/ Singulair
20 mg daily for six months
• Placebo
Placebo 20 mg daily for 6 months

Locations
Country Name City State
United States Mayo Clinic Rochester Minnesota

Sponsors (2)
Lead Sponsor Collaborator
Mayo Clinic Merck Sharp & Dohme Corp.

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary evaluate effectiveness of oral montelukast in treatment of EE. 6 months No
Secondary evaluate safety of montelukast in eosinophilic esophagitis 6 months Yes
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