NCT02371941

Oral Cromolyn Sodium for the Treatment of Eosinophilic Esophagitis

A Randomized, Double-blind, Placebo-controlled Study of the Use of Oral Cromolyn Sodium for the Treatment of Eosinophilic Esophagitis

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: University of Tennessee · Academic / Other
• Sex: All
• Age: 2 Years – 18 Years
• Healthy volunteers: Not accepted

Summary

This is a randomized, double-blind, placebo-controlled study of oral cromolyn sodium when made into a viscous preparation for the treatment of eosinophilic esophagitis.

Detailed description

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.

Conditions

• Eosinophilic Esophagitis

Interventions

Type	Name	Description
DRUG	oral cromolyn sodium	Oral cromolyn sodium
DRUG	Placebo	Saline

Timeline

• Start date: 2014-12-01
• Primary completion: 2017-07-01
• Completion: 2017-12-01
• First posted: 2015-02-26
• Last updated: 2023-10-26
• Results posted: 2023-10-26

Locations

1 site across 1 country: United States