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Trial of Montelukast in Eosinophilic Esophagitis

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ClinicalTrials.gov Identifier: NCT00511316
Recruitment Status : Completed
First Posted : August 3, 2007
Last Update Posted : November 3, 2015
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Jeffrey A Alexander, 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.


Condition or disease Intervention/treatment Phase
Eosinophilic Esophagitis Drug: Montelukast/ Singulair Drug: Placebo Phase 1

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 41 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized Placebo-Controlled Trial of Montelukast in Maintenance Therapy of Asymptomatic Eosinophilic Esophagitis
Study Start Date : August 2007
Actual Primary Completion Date : September 2015
Actual Study Completion Date : September 2015


Arm Intervention/treatment
Experimental: Drug
20 mg montelukast daily for 6 months
Drug: Montelukast/ Singulair
20 mg daily for six months
Other Name: Singulair
Placebo Comparator: Placebo
20 mg daily placebo
Drug: Placebo
Placebo 20 mg daily for 6 months



Primary Outcome Measures :
  1. evaluate effectiveness of oral montelukast in treatment of EE. [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. evaluate safety of montelukast in eosinophilic esophagitis [ Time Frame: 6 months ]


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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00511316


Locations
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Merck Sharp & Dohme Corp.
Investigators
Principal Investigator: Jeffrey A. Alexander, M.D. Mayo Clinic

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Jeffrey A Alexander, Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier: NCT00511316     History of Changes
Other Study ID Numbers: 06-003373
First Posted: August 3, 2007    Key Record Dates
Last Update Posted: November 3, 2015
Last Verified: November 2015

Additional relevant MeSH terms:
Esophagitis
Eosinophilic Esophagitis
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Gastroenteritis
Eosinophilia
Leukocyte Disorders
Hematologic Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Montelukast
Anti-Asthmatic Agents
Respiratory System Agents
Leukotriene Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Cytochrome P-450 CYP1A2 Inducers
Cytochrome P-450 Enzyme Inducers
Molecular Mechanisms of Pharmacological Action