Oral Cromolyn Sodium for the Treatment of Eosinophilic Esophagitis
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|ClinicalTrials.gov Identifier: NCT02371941|
Recruitment Status : Unknown
Verified March 2015 by University of Tennessee.
Recruitment status was: Recruiting
First Posted : February 26, 2015
Last Update Posted : March 13, 2015
|Condition or disease||Intervention/treatment||Phase|
|Eosinophilic Esophagitis||Drug: oral cromolyn sodium Drug: Placebo||Phase 4|
Eosinophilic esophagitis is an antigen-mediated allergic disease of the esophagus characterized by symptoms of gastrointestinal complaints and eosinophilic inflammation limited to the esophagus. Currently, first line therapeutic recommendations include swallowed, topical steroids or dietary therapy. While both work for the majority of patients, they both have limitations.
The investigators are examining the use of oral cromolyn sodium as a treatment for this condition. This medication is a non-steroid that is already approved for other conditions. When taken orally, it is essentially not absorbed systemically, so side effects are minimal. There is only 1 brief, retrospective report of its use in this condition suggesting it does not work. However, from studying swallowed, topical steroids, it may require formulating the medication into a viscous preparation for it to work.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||24 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||A Randomized, Double-blind, Placebo-controlled Study of the Use of Oral Cromolyn Sodium for the Treatment of Eosinophilic Esophagitis|
|Study Start Date :||December 2014|
|Estimated Primary Completion Date :||December 2015|
Experimental: Oral cromolyn
Subjects randomized to the experimental arm will receive oral cromolyn sodium. The dose will be per current package insert for oral cromolyn:
Subjects 2-12 years of age - 100 mg (1 ampule) 4 times daily Subjects 13-18 years of age - 200 mg (2 ampules) 4 times daily
Drug: oral cromolyn sodium
Oral cromolyn sodium
Other Name: Gastrocrom
Placebo Comparator: Placebo
Subjects randomized to placebo will receive normal saline ampules Subjects 2-12 years of age - 1 ampule 4 times daily Subjects 13-18 years of age - 2 ampules 4 times daily
- Peak esophageal eosinophil count [ Time Frame: 2 months ]Measure of the peak esophageal eosinophil count on esophageal biopsy specimens after 2 months of therapy
- Symptoms as measured by Pediatric Eosinophilic Esophagitis Symptom Score [ Time Frame: 1 month and 2 month ]Symptom scores will be measures at baseline, 1 month, and 2 months using a symptom scoring assessment tool known as the Pediatric Eosinophilic Esophagitis Symptom Score.
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): NCT02371941
|Contact: Jay A Lieberman, MDfirstname.lastname@example.org|
|United States, Tennessee|
|LeBonheur Children's Hospital||Recruiting|
|Memphis, Tennessee, United States, 38105|
|Contact: Jay A Lieberman, MD 901-287-5283 email@example.com|
|Principal Investigator:||Jay A Lieberman, MD||The University of Tennessee Health Science Center|