Trial of Montelukast in Eosinophilic Esophagitis
This study is currently recruiting participants.
Verified January 2013 by Mayo Clinic
Sponsor:
Mayo Clinic
Collaborator:
Merck
Information provided by:
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00511316
First received: August 1, 2007
Last updated: January 23, 2013
Last verified: January 2013
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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 1 |
| 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:
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: | October 2013 |
| Estimated Primary Completion Date: | August 2013 (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: Debra M. Geno, CCRP 507-538-0367 geno.debra@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:
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: | January 23, 2013 |
| 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 May 23, 2013