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A Trial of Montelukast for Maintenance Therapy of Eosinophilic Esophagitis in Children
This study has been terminated.
(Inability to complete enrollment due to difficulty in finding subjects)
Sponsor:
Children's Mercy Hospital Kansas City
Information provided by (Responsible Party):
Children's Mercy Hospital Kansas City
ClinicalTrials.gov Identifier:
NCT01458418
First received: October 18, 2011
Last updated: February 17, 2015
Last verified: February 2015
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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 Intervention Model: Parallel Assignment Masking: Double Blind (Participant, Care Provider, 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 ]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 ]
| Enrollment: | 4 |
| Study Start Date: | December 2011 |
| Study Completion Date: | February 2015 |
| Primary Completion Date: | February 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 (Child) |
| Sexes Eligible for Study: | All |
| 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
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01458418
Please refer to this study by its ClinicalTrials.gov identifier: NCT01458418
Locations
| United States, Missouri | |
| Children's Mercy Hospitals and Clinics | |
| Kansas City, Missouri, United States, 64108 | |
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: | February 17, 2015 |
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 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 |
ClinicalTrials.gov processed this record on July 11, 2017