A Trial of Montelukast for Maintenance Therapy of Eosinophilic Esophagitis in Children

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Children's Mercy Hospital Kansas City
Sponsor:
Information provided by (Responsible Party):
Children's Mercy Hospital Kansas City
ClinicalTrials.gov Identifier:
NCT01458418
First received: October 18, 2011
Last updated: March 18, 2014
Last verified: March 2014
  Purpose

Eosinophilic Esophagitis (EE) is a condition where eosinophils (a cell that fights infection) travel to the esophagus (the tube through which food passes to the stomach). These cells do not belong there and can cause pain, soreness, difficulty swallowing and sometimes vomiting.

Ways to treat this condition include medicine, not eating some foods, and drinking a specific formula (like milk) without eating any other foods. Doing these things can help fight off EE but these problems can come back when treatment is stopped. If EE symptoms go on for a long time, it can lead to the esophagus becoming narrow and feeling tight when eating and swallowing and surgery may be needed to widen the narrowed area to relieve the sensation of tightening.

Montelukast is a medicine that fights off a type of chemical that can be a magnet for eosinophils. People usually take this medicine to help treat their asthma. It is not approved to treat EE. This medication is taken once a day.

The purpose of this study is to see if Montelukast, compared to placebo, will help reduce the number of eosinophils in children with EE and help stop the tightening of the esophagus.


Condition Intervention
Eosinophilic Esophagitis
Drug: Montelukast
Other: placebo
Drug: 5 mg Montelukast

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Trial of Montelukast for Maintenance Therapy of Eosinophilic Esophagitis in Children

Resource links provided by NLM:


Further study details as provided by Children's Mercy Hospital Kansas City:

Primary Outcome Measures:
  • Eosinophil count [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Eosinophils/hpf in the esophagus will be measured after 12 weeks of therapy.


Secondary Outcome Measures:
  • Amount of MBP, tryptase and trichrome found in esophageal specimens [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: December 2011
Estimated Study Completion Date: October 2015
Estimated Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Montelukast 10 mg/day
Subjects will receive two 5mg tablets of Montelukast/day.
Drug: Montelukast
Those in Montelukast 10mg/day group will receive two 5mg tablets of Montelukast.
Other Name: Singulair
Experimental: Montelukast 5mg/day
Subjects will receive one 5mg tablet of montelukast and 1 placebo tablet per day.
Drug: 5 mg Montelukast
Subject will receive one 5mg tablet of Montelukast and one placebo tablet per day.
Other Name: Singulair
Placebo Comparator: placebo
Subjects will receive two placebo tablets per day.
Other: placebo
Those in the placebo group will receive 2 placebo tablets per day. Those in the Montelukast 5mg/day will receive 1 placebo tablet per day.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   2 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Males and females aged 2-17
  • Presence of more than 15 eosinophils per hpf on original endoscopy and less than 5 eosinophils/hpf on the most recent endoscopy
  • Concurrent PPI for 1 month at 1-2mg/kg/dose prior to endoscopy or have a negative pH study
  • English speaking
  • Ability to undergo a follow up endoscopy between 12 and 13 weeks after the start of the study
  • Procurement of written informed consent signed by the subject's legal guardian and study investigator (s) and subject assent.

Exclusion Criteria:

  • Subjects with eosinophils in stomach and duodenum on original endoscopy.
  • Subjects requiring oral prednisone within 1 month of current endoscopy.
  • Subjects with diagnosis of other co-morbid diseases such as heart disease, renal disease, autoimmune disease, an immunodeficiency, diabetes, phenylketonuria, or thyroid disease.
  • Subjects using Montelukast within one month of current endoscopy
  • Subjects with concurrent use of phenobarbital or rifampin
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01458418

Contacts
Contact: Corey Schurman, MA 816-802-1167 crschurman@cmh.edu
Contact: Shawna Ricks, RN 816-234-3197 sricks@cmh.edu

Locations
United States, Missouri
Children's Mercy Hospitals and Clinics Recruiting
Kansas City, Missouri, United States, 64108
Contact: Corey Schurman, MA    816-802-1167    crschurman@cmh.edu   
Contact: Stephanie Page, MD    816-234-3016      
Principal Investigator: Stephanie Page, MD         
Sub-Investigator: Kathe Menown, APRN         
Sub-Investigator: Jennifer Schurman, PhD         
Sub-Investigator: Jose Cocjin, MD         
Sub-Investigator: James Daniel, MD         
Sub-Investigator: Craig Friesen, MD         
Sponsors and Collaborators
Children's Mercy Hospital Kansas City
Investigators
Principal Investigator: Stephanie Page, MD Children's Mercy Hospital
  More Information

Publications:

Responsible Party: Children's Mercy Hospital Kansas City
ClinicalTrials.gov Identifier: NCT01458418     History of Changes
Other Study ID Numbers: CMH 11 01-007
Study First Received: October 18, 2011
Last Updated: March 18, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Children's Mercy Hospital Kansas City:
Eosinophil
Esophagitis

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
Therapeutic Uses
Pharmacologic Actions
Leukotriene Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 18, 2014