Phase 4 N=16 Randomized Triple-blind Treatment

Oral Cromolyn Sodium for the Treatment of Eosinophilic Esophagitis

Eosinophilic Esophagitis

Bottom Line

View on ClinicalTrials.gov: NCT02371941 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Oct 2023

Primary outcome: Primary: Peak Esophageal Eosinophil Count — 57.3; 71.3 Peak # of eosinophils counted per field

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: oral cromolyn sodium (Drug); Placebo (Drug)
Age: Pediatric, Adult · 2+ yrs
Sex: All
Sponsor: University of Tennessee
Primary completion: Jul 2017

Outcome Measures

Outcome	Result	p-value
PRIMARY Peak Esophageal Eosinophil Count	57.3; 71.3	—
SECONDARY Symptoms as Measured by Pediatric Eosinophilic Esophagitis Symptom Score	37.89; 30.3; 17.5; 22.3	—

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.

Eligibility Criteria

Inclusion Criteria

Diagnosis of eosinophilic esophagitis

Exclusion Criteria

Concomitant treatment with swallowed corticosteroids. Any prior use of swallowed corticosteroids will require a 4 week washout period.
Pregnancy (all females of child bearing potential will have urine pregnancy test done at baseline).
Evidence of pathologic eosinophilia in other locations in the GI tract.
Participation in another research protocol
Reduced Renal or Hepatic Function (all subjects will have a baseline creatinine and liver function panel drawn)

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02371941). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.