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Oral Cromolyn Sodium for the Treatment of Eosinophilic Esophagitis

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ClinicalTrials.gov Identifier: NCT02371941
Recruitment Status : Completed
First Posted : February 26, 2015
Last Update Posted : May 4, 2018
Sponsor:
Information provided by (Responsible Party):
University of Tennessee

Brief 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.

Condition or disease Intervention/treatment Phase
Eosinophilic Esophagitis Drug: oral cromolyn sodium Drug: Placebo Phase 4

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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
Actual Primary Completion Date : July 2017
Actual Study Completion Date : December 2017


Arm Intervention/treatment
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
Drug: Placebo
Saline




Primary Outcome Measures :
  1. Peak esophageal eosinophil count [ Time Frame: 2 months ]
    Measure of the peak esophageal eosinophil count on esophageal biopsy specimens after 2 months of therapy


Secondary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   2 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

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


Locations
United States, Tennessee
LeBonheur Children's Hospital
Memphis, Tennessee, United States, 38105
Sponsors and Collaborators
University of Tennessee
Investigators
Principal Investigator: Jay A Lieberman, MD The University of Tennessee Health Science Center

Responsible Party: University of Tennessee
ClinicalTrials.gov Identifier: NCT02371941     History of Changes
Other Study ID Numbers: 13-02521-FB
First Posted: February 26, 2015    Key Record Dates
Last Update Posted: May 4, 2018
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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
Cromolyn Sodium
Anti-Asthmatic Agents
Respiratory System Agents