Phase 4
Completed N=16
Oral Cromolyn Sodium for the Treatment of Eosinophilic Esophagitis
Source: ClinicalTrials.gov NCT02371941 ↗Enrolled (actual)
16
Serious AEs
0.0%
Results posted
Oct 2023
Primary outcomePrimary: Peak Esophageal Eosinophil Count — 57.3; 71.3 Peak # of eosinophils counted per field
◆ Published Evidence
Established
40citations · ~5 / year
A randomized, double-blinded, placebo-controlled study of the use of viscous oral cromolyn sodium for the treatment of eosinophilic esophagitis.
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.
Linked Publications
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A randomized, double-blinded, placebo-controlled study of the use of viscous oral cromolyn sodium for the treatment of eosinophilic esophagitis.
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 | — |
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)
Data sourced from ClinicalTrials.gov (NCT02371941) and the linked publication. 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. Informational only — not medical advice.