Trial of Montelukast in Eosinophilic Esophagitis - Full Text View

Sponsor:	Mayo Clinic
Collaborator:	Merck
Information provided by:	Mayo Clinic
ClinicalTrials.gov Identifier:	NCT00511316

Purpose

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	Intervention	Phase
Eosinophilic Esophagitis	Drug: Montelukast/ Singulair Drug: Placebo	Phase I

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment
Official Title:	A Randomized Placebo-Controlled Trial of Montelukast in Maintenance Therapy of Asymptomatic Eosinophilic Esophagitis

Resource links provided by NLM:

Drug Information available for: Montelukast sodium Montelukast

U.S. FDA Resources

Further study details as provided by Mayo Clinic:

Primary Outcome Measures:

evaluate effectiveness of oral montelukast in treatment of EE. [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

evaluate safety of montelukast in eosinophilic esophagitis [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	60
Study Start Date:	August 2007
Estimated Study Completion Date:	August 2012
Estimated Primary Completion Date:	August 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
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).

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00511316

Locations

United States, Minnesota
Mayo Clinic	Recruiting
Rochester, Minnesota, United States, 55905
Contact: Christine R Kujath 507-266-9138 kujath.christine@mayo.edu
Principal Investigator: Jeffrey A. Alexander, M.D.

Sponsors and Collaborators

Mayo Clinic

Merck

Investigators

Principal Investigator:

Jeffrey A. Alexander, M.D.

Mayo Clinic

More Information

Additional Information:

Mayo Clinic Clinical Trials This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Jeffery A. Alexander M.D., Mayo Clinic Rochester
ClinicalTrials.gov Identifier:	NCT00511316 History of Changes
Other Study ID Numbers:	06-003373
Study First Received:	August 1, 2007
Last Updated:	December 7, 2011
Health Authority:	United States: Institutional Review Board

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
Leukotriene Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on February 09, 2012