Trial of Montelukast in Eosinophilic Esophagitis
A Randomized Placebo-Controlled Trial of Montelukast in Maintenance Therapy of Asymptomatic Eosinophilic Esophagitis
1 other identifier
interventional
41
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Aug 2007
Longer than P75 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 1, 2007
CompletedStudy Start
First participant enrolled
August 1, 2007
CompletedFirst Posted
Study publicly available on registry
August 3, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2015
CompletedNovember 3, 2015
November 1, 2015
8.1 years
August 1, 2007
November 2, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
evaluate effectiveness of oral montelukast in treatment of EE.
6 months
Secondary Outcomes (1)
evaluate safety of montelukast in eosinophilic esophagitis
6 months
Study Arms (2)
Drug
EXPERIMENTAL20 mg montelukast daily for 6 months
Placebo
PLACEBO COMPARATOR20 mg daily placebo
Interventions
Eligibility Criteria
You may qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mayo Cliniclead
- Merck Sharp & Dohme LLCcollaborator
Study Sites (1)
Mayo Clinic
Rochester, Minnesota, 55905, United States
Related Publications (1)
Alexander JA, Ravi K, Enders FT, Geno DM, Kryzer LA, Mara KC, Smyrk TC, Katzka DA. Montelukast Does not Maintain Symptom Remission After Topical Steroid Therapy for Eosinophilic Esophagitis. Clin Gastroenterol Hepatol. 2017 Feb;15(2):214-221.e2. doi: 10.1016/j.cgh.2016.09.013. Epub 2016 Sep 17.
PMID: 27650328DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jeffrey A. Alexander, M.D.
Mayo Clinic
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
August 1, 2007
First Posted
August 3, 2007
Study Start
August 1, 2007
Primary Completion
September 1, 2015
Study Completion
September 1, 2015
Last Updated
November 3, 2015
Record last verified: 2015-11